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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-80.0, Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 adult outpatients (≥20 and ≤80 years) T1 or T2 diabetes mellitus basal-bolus insulin regimen (basal insulin, i.e. Glargine, Detemir or Degludec, plus at least two prandial insulin shots) for at least six months assuming three daily meals capable of informed consent pregnancy breast-feeding severe liver or renal failure (eGFR <30 mL/min/1.73 m2) use of OADs (except for metformin) hospitalization for any cause in the last six month glucocorticoid treatment in the last six month oncologic treatment in the last six month Ramadan in the last six months
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-75.0, Type 1 Diabetes Mellitus Age ≥ 18 and ≤ 75 years at the time of screening Clinical diagnosis of type 1 diabetes for at least one year Has been using an insulin pump for at least 6 months at the time of screening HbA1c < 10.5% Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate Willing to perform at least 7 fingerstick blood glucose tests a day If using Apidra (insulin glulisine) at home and planning to use the Tandem t:AP pump for the closed-loop session, willing to switch to Novolog or Humalog for the closed-loop session Willing to refrain from taking acetaminophen products for the duration of the clinical trial Willing to abide by the study protocol and use study-provided devices, including the Omnipod OR Tandem Pump, Dexcom CGM, glucometer, ketone meter and APS APP on the study phone device Pregnancy One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination Dermatological conditions that would preclude wearing a CGM sensor or Pod/infusion site One or more seizures in the past year Any condition that could interfere with participating in the trial, based on investigator judgment Participation in another pharmaceutical or device trial at the time of enrollment or during the study
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperglycemia Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney. 2. Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose < 126 mg/dl). 3. Receiving standard triple immunosuppressive medications that tacrolimus (once-daily in Europe, twice-daily in the U.S.), mycophenolate mofetil or mycophenolic sodium and steroids. 4. Capable of understanding the study and willing to give informed written consent for study participation Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dl on two occasions at least three days apart. 2. Patients receiving an organ transplant other than kidney. 3. Patients receiving an unlicensed drug or therapy within one month prior to study entry. 4. Patients with history of hypersensitivity to injectable insulin. 5. Patients with documented HIV infection
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-80.0, Type2 Diabetes Mellitus type 2 diabetes patients 2. aged 20-80 years 3. had been on premixed insulin and used an insulin pen for at least 3 months 4. fasting glucose between 6.1-16 mmolL, postprandial(or random) glucose below 22.2mmol/L. 5. No acute complications such as diabetic ketoacidosis, diabetic hypertosmolar syndrome. 6. Subjects were able and willing to ues CGMS and eat regularly. 7. Patients who were able to inject insulin themselves or actual injections can be accompanied Insulin allergy. 2. There has been a history of drug abuse and alcohol dependence in the past five years, or systemic hormone therapy within 3 months. 3. Patients with poor compliance and irregular eating and exercise. 4. Infection or stress within four weeks. 5. Patients unable to tolerate CGMS. 6. patients with pregnancy, breast-feeding, planning to have a baby 7. patients with coagulopathy, serious complication,such as cardiovascular disease, end stage renal disease; and patients with severe retinopathy or other eye problems that impair their visual function, or cognitive dysfunction
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Heart Failure Diabetes General for both H-HeFT and Met-HeFT Patients with chronic heart failure NYHA-class II, III or IV LVEF </= 40% within 12 months prior to screening. The echocardiography should (i) be performed after uptitration in heart failure medication and (ii) LVEF from the most recently performed echocardiographic study should be used and (iii) LVEF must not be measured during rapid atrial fibrillation, i.e. heart rate >110/min) and (iiii) the echocardiography should be performed at least 3 months after CRT-implantation Patients should be uptitrated to recommended or maximally tolerated dose of ACE-I/ARB/ARNI (unless contraindicated) and beta-blocker (unless contraindicated). If indicated, an aldosterone receptor antagonist should be given (unless contraindicated) A CRT device should be implanted, if indicated and accepted by the patient and patients with a CRT device should be treated for > 3 months Implantation of an ICD unit should be planned or already done, if indicated and accepted by the patient. The patient can be included in the study before a planned ICD implantation has been performed Informed consent Specific for only H-HeFT Systolic blood pressure ≥100 mmHg NT-proBNP > 350 pg/ml or BNP > 80 pg/ml (in patients treated with ARNI, NT-proBNP must be used) Specific for only Met-HeFT: Patients must have a diagnosis of type 2 diabetes or insulin resistance or diabetes risk. This includes 1 or more of any of the following
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-99.0, End-Stage Renal Disease Diabetes Mellitus Adult patients over 18 years old with diabetes (both sexes) presenting without any kidney disease or with ESRD on hemodialysis Undergoing major elective surgery procedures such as abdominal, pulmonary, GU/GYN, vascular, renal, neurologic, and orthopedic surgery Signed informed consent for the study Patients with elevated preoperative blood glucose of a value > 150 mg/dL or < 350 mg/dL English-speaking Baseline chemistry with a potassium at or above 3.5 Patients under the age of 18 Pregnant women. (Pregnant women have altered glucose metabolism; specific insulin regimen used for pregnant women) Patient does not give informed consent for the study Patient does not have decisional capacity or a surrogate Patient cannot understand or read English Patients with a preoperative blood glucose < 150 mg/dL or >350 mg/dL Patients without diabetes Patients with kidney disease that are not on hemodialysis A history of frequent hypoglycemia in the month prior to surgery by history or a change in insulin dose for hypoglycemia in the month prior to surgery Patients taking steroids or patients that will receive steroids during their surgery
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 2.0-18.0, Diabetes Type 1 Age between 2 and 18 years Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody insulin-treated type 2 diabetes by daily injections or insulin pump Trouble to read Trouble to understand Trouble to answer to the questionnaire Opposition
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 13.0-999.0, Asthma Adolescents who are at least 13.0 at the time of consent Teenager reports having a prior asthma diagnosis, and in the last 12 months has: (a) used prescribed asthma medication and (b) uncontrolled asthma, defined as: (i) symptoms 3+ days a week; (ii) night awakenings 3+ nights per month; (iii) 2+ ED visits; or (iv) 1+ hospitalization for asthma; and Adolescents are English proficient • Co-morbid diseases that affect lung functioning
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 14.0-999.0, Type 1 Diabetes Mellitus Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year. 2. Familiarity and use of a carbohydrate ratio for meal boluses. 3. Age ≥14.0 years old. 4. For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 5. For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency. 6. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use. 7. Willingness to use a regular insulin pump during the study with no automatic insulin adjustment based on glucose level when assigned to participate in an SAP group 8. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol. 9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study. 10. Total daily insulin dose (TDD) at least 10 U/day. 11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). 2. Hemophilia or any other bleeding disorder. 3. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. 4. Participation in another pharmaceutical or device trial at the time of enrollment or during the study. 5. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc. or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-29.0, Type1diabetes Type 1 diabetes
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-70.0, Non Alcoholic Fatty Liver Disease Type2 Diabetes Mellitus A man or woman, 20 years of age or above with the diagnosis of type 2 diabetes for at least 3 months who meets all of the following two 1. On standard anti-diabetic agents (metformin, DPP-4 inhibitors, sulphonylureas or insulin, in any combination) with an HbA1c of ≤ 7.0% and ≥10.0% (≤53 and ≥86 mmol/mol) at screening 2. Have documented hepatic steatosis (MRI-PDFF >6%) on screening MRI-PDFF 2. Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations. 3. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol. 4. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy. 2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely. 3. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score ≥8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years. 4. Thyroid stimulating hormone (TSH) value that is either < 0.45 mIU/L or >10 mIU/L at Screening. Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment. 5. Use of a PPARγ agonist [e.g., a thiazolidinedione (pioglitazone], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin) or another GLP-1 receptor agonist (e.g., liraglutide) within 24 weeks before the enrollment. 6. BMI ≥23 kg/m2 or ≤40 kg/m2. 7. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report. 8. Use of weight loss medication (prescription and/or over-the-counter) within 3 months prior to Screening or have participated in a weight loss/diet program within 12 months prior to Screening. 9. Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant. 10. Myocardial infarction, unstable angina, pulmonary hypertension, revascularisation procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularisation procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease. 11. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening. 12. Use of vitamin E within 3 months before screening. 13. History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection). 14. History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder. 15. Estimated glomerular filtration rate (eGFR) <65 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation. 16. Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination. 17. Screening fasting serum triglycerides ≥600 mg/dL (6•74 mmol/L). 18. Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures. 19. Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening. 20. History of human immunodeficiency virus (HIV) antibody positive at Screening. 21. Major surgery (e.g., requiring general anaesthesia) within 12 weeks before Screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. 22. Contraindications to the use of dulaglutide (per US Prescribing Information). 23. Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication or an immunosuppressive agent. Note: Subjects using inhaled, intranasal, intra-articular, or topical corticosteroids, or corticosteroids in therapeutic replacement doses may participate. 24. Pregnancy or women breastfeeding or planning to become pregnant while enroled in this study. 25. History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 26. Use of drugs known to cause hepatic steatosis like methotrexate
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 1 Diabetes >18 years type 1 diabetes had been treated with insulin pump for more than three months had hypoglycemia unawareness with a hypoglycemia perception threshold below 60 mg/dL and/or had had at least one severe hypoglycemia event in the previous year > 18 years any serious disease that could interfere with the study pregnancy incompatibility with monitoring irregular management of diabetes hearing loss and low vision preventing them from using the devices
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 40.0-59.0, Diabetes Mellitus, Type 2 Signature of consent under written information prior to the completion of any procedure in the study Men and women aged 40 to 59 years old, residents of Guadalajara, Jalisco and the metropolitan area Ability to communicate and meet all the requirements of the study BMI less than or equal to 34.9 kg / m2 Diagnosis of DM2 according to the ADA Plasmatic glucose ≥126mg / dl (7.0 mmol / L) in an 8-hour fast Plasmatic glucose ≥200mg / dl (11.1 mmol / L) at 2 hours after an oral glucose tolerance test. or HbA1C ≥6.5% (48 mmol / mol). o Plasmatic glucose ≥200mg / dl (11.1 mmol / L) in a random sample to the patient with classic symptoms of hyperglycemia Evolution of DM2 less than 1 year Be receiving pharmacological treatment with metformin in doses less than or equal to 850mg Stable body weight within 3 months prior to the start of the study, defined as a variability in body weight of less than 10% Determination of HbA1c less than 6.5%, greater than 10% or fasting glucose greater than 250 mg / dL Serum total cholesterol concentration greater than or equal to 240mg / dl Serum triglyceride concentration greater than or equal to 400mg / dl History of hypersensitivity to study drugs Intake of drugs with known effects on glucose metabolism, lipids, and weight Uncontrolled arterial hypertension, defined as systolic blood pressure values greater than or equal to 140mm / Hg and a diastolic blood pressure greater than or equal to 90mm / Hg History of cardiovascular disease, blood disorders, kidney, pancreatic or thyroid disease Women with suspicion or confirmation of pregnancy Women in breastfeeding period History of smoking at any intensity within 12 months prior to the start of the study
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 1 Adults ≥18years of age Diagnosis of T1DM for > 1 year Structured education completed in last 3 years and capable of CHO counting CBG measured at least twice daily for CGM calibration Capacity to follow the protocol and sign the informed consent Access to a personal computer/laptop Severe episode of hypoglycaemia (requiring 3rd party assistance) in last 6 months Diabetic ketoacidosis in the last 6 months prior to enrolment Impaired awareness of hypoglycaemia (based on Gold score) Pregnant or planning pregnancy over time of study procedures Breastfeeding Enrolled in other clinical trials Active malignancy or being investigated for malignancy Suspected or diagnosed endocrinopathy like adrenal insufficiency, unstable thyroidopathy, endocrine tumour Gastroparesis Autonomic neuropathy
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-85.0, Diabetic Ketoacidosis Diagnosis of diabetic ketoacidosis defined as: 1. Blood sugar greater than 250 mg/dl 2. Venous pH less than 7.25 3. Bicarbonate less than 18 4. Evidence of ketone formation with either positive urine ketones or elevated beta-hydroxybutyrate > 3 5. Anion gap greater than 10 +/ (or higher than expected anion gap corrected for albumin) 2. 18-85 years of age Pregnancy 2. Hyperglycemic hyperosmolar state 3. Ketosis from other etiology such as starvation or alcoholic ketosis 4. Acute exacerbation of congestive heart failure 5. Acute coronary syndrome or non-ST elevation MI 6. Pulmonary edema from other cause such as decompensated liver failure or acute renal failure 7. Renal failure requiring renal replacement therapy (hemodialysis) 8. Septic shock
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hypertension Diabetes Mellitus Clinical Staff Subjects Must be a current clinic or pharmacy service employee who works as a provider, pharmacist, nurse, clerk or administrator Patient Subjects English or Spanish speaking Seen in the clinic at least once in the previous 12 months Currently has one of the following diseases: 1. Diabetes with HA1c 9.0% or greater and/or 2. Hypertension (uncomplicated) with systolic blood pressure 150 mm Hg or greater Informal Caregiver Subjects Person identified by the patient subject who assists the patient subject with activities of daily living or other aspects of the patient subject's healthcare Study wide exclusions Inability to give consent Nursing home residence No telephone Additional patient subject exclusions Cancer with a life expectancy less than 24 months Pregnancy Diagnosis of dementia Plans to terminate care from the clinic within 24 months
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Diabetes Mellitus, Type 1 Males or females ≥18 and ≤65 years of age. 2. Type 1 diabetes mellitus (diagnosed clinically and treated with multiple daily injections of insulin) for ≥12 months. 3. HbA1c <10% within 30 days of being enrolled in the study 4. Current treatment with any basal insulin analogue as the once daily basal insulin given in the evening (22) and no fewer than three injections with rapid acting bolus insulin (e.g. insulin aspart, insulin lispro, or insulin glulisine) as mealtime bolus insulin therapy. 5. No contraindication to long-haul travel. 6. No recurrent severe hypoglycemia (more than 1 severe hypoglycemic event requiring hospitalization during the last 12 months), or hypoglycemia unawareness as judged by a score of >4 on the Gold score (23), or hospitalization for diabetic ketoacidosis during the previous 6 months. 7. Willing and able to use a continuous glucose monitoring device (e.g. Dexcom G4). 8. Ability to self-manage insulin therapy (verbal confirmation at screening visit) of a changed bolus insulin dose the preceding 2 months prior to screening. 9. Ability and willingness to adhere to the protocol, including performance of self-monitored blood glucose (SMBG) readings and self-adjustment of insulin doses according to protocol. - Current use of an insulin pump. 2. Use within the last 3 months prior to enrollment visit 1 of any glucose-lowering drug other than insulin. 3. Initiation or significant change of any systemic treatment which, in the investigator's opinion, could interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers or monoamine oxidase inhibitors (inhaled corticosteroids allowed). 4. Proliferative retinopathy or maculopathy requiring treatment, according to the investigator. 5. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures. 6. Any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial. 7. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or cooperation, including subjects not able to read or write, and known or suspected abuse of alcohol, narcotics, or illicit drugs. 8. Known or suspected allergy to any of the trial products or related products. 9. Receipt of any investigational drug or participation in other trials within 1 month prior to Visit 1. -
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 6.0-999.0, Type 1 Diabetes Mellitus Cognitive Change Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year, using insulin for at least 1 year and using an insulin pump for at least 6 months Familiarity and use of a carbohydrate ratio for meal boluses by participants and families participating Age 6-10 years old or 65 years or older Hemoglobin A1c <10% For females of child-bearing potential, not currently known to be pregnant: A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency Willing to disable any automated insulin delivery functionality on a personal insulin pump during study, such as Medtronic 670G in auto mode. Predictive low blood glucose suspend, such as Tandem insulin pump with Basal-IQ, will be allowed Investigator has confidence that the participant and family can successfully operate all study devices and is capable of adhering to the protocol Willingness to switch to lispro (Humalog) or aspart (Novolog) and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study Total daily insulin dose (TDD) at least 10 U/day Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment Diagnosis of Diabetic Ketoacidosis in the 12 months prior to enrollment Uncontrolled cardiac disease (e.g. recent myocardial infarction, severe congestive heart failure) Cerebrovascular accident in the 12 months prior to enrollment Uncontrolled resting arterial hypertension (>160/90 mm Hg) Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility) Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) Hemophilia or any other bleeding disorder A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-60.0, Painful Diabetic Neuropathy Voluntary participation and signing informed consent to 60 years old with junior high school education or above meeting the 1999 WHO type 2 diabetes diagnostic having symptoms of diabetes (polydipsia, polyphagia, polyuria and unexplained weight loss) plus one of the following 3 items: (1) random blood glucose more than 11.1 mmol/L; (2) fasting blood glucose more than 7 mmol/L; (3) after 2 hours glucose load, the blood sugar more than 11.1 mmol/L The diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain left-hand writers neuropathy caused by other causes, such as cervical spondylosis, cerebral infarction, Green Barre syndrome; severe arteriovenous disease; neurotoxic changes caused by drugs and renal insufficiency patients with severe cerebral vascular disease diagnosed mental disorders such as depression, anxiety and Alzheimer's disease patients who can't accept head magnetic resonance imaging, such as those with metal (stents, metal dentures, internal fixation plates, etc.), and claustrophobic space phobias
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetic Ketoacidosis Bicarbonate ≤15 mEq/L Anion gap > 12 mEq/L Blood pH≤ 7.24 (if already obtained by clinical team) Urine ketones (qualitative) or serum ketones (β-hydroxybutyric acid) > 3 mmol/L Enrollment within 6 hours of presentation Current thiamine supplementation ≥ 6 milligrams per day (i.e., more than a multivitamin) Competing causes of severe acidosis including seizure, carbon monoxide poisoning, cyanide toxicity, cardiac arrest, liver dysfunction (specifically defined as known cirrhosis) Known allergy to thiamine Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic) Research-protected populations (pregnant women, prisoners, the intellectually disabled) Patient enrolled previously in same study Code status of Do Not Resuscitate/Do Not Intubate (DNR/DNI) or Comfort Measures Only (CMO)
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.0-999.0, Type 1 Diabetes Mellitus Diagnosis of type 1 diabetes Living in the province of Quebec (Canada) Type 2 diabetes Gestational diabetes
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-75.0, Type 1 Diabetes Mellitus Criteria:stimulated c peptide <0.03 mmol/l type 1 diabetes - • Type 2 diabetes Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives Pregnant or nursing women Cancer unless in complete remission for > 5 years Treatment with oral glucocorticoids Hypoglycaemia unawareness (unability to register low blood glucose) Known or suspected hypersensitivity to trial product or related products Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators Receipt of an investigational drug within 30 days prior to visit 0 Simultaneous participation in any other clinical intervention trial
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Type 1 Diabetes Male or female, 18 to 70 years old (including 18 and 70 years old) 2. Diagnosed as type I diabetes, the diagnostic refer to the 1990 WHO diabetes diagnostic （1）Diabetes symptoms (hyperglycemia caused by polydipsia, polyphagia, weight loss, itchy skin, blurred vision and other acute metabolic disorders) + random blood glucose ≥ 11.1nmol / L; （2）Fasting blood glucose ≥7.0mmol/L or 75g glucose meets 2-hour blood glucose ≥11.1mmol/L. 3、Voluntary informed consent is given, agree to follow the trial treatment and visit plan. Note: 2 is the venous plasma glucose level, if there is no diabetes symptoms, it is necessary to repeat the test on the next day Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc. 2. Patients with Severe bacterial and viral infections 3. patients are participating in other clinical trials and treating with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets) 4. Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study 5. Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit). 6. Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR <60 ml/min/1.73 m2) 7. Women in pregnancy (urine/blood pregnancy test positive) or lactation; men or women with pregnancy plans in the last year; patients are not guaranteed to take effective contraceptive measures during the trial; 8. patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years. 9. Other circumstances that researchers do not consider suitable for research. 10. Withdrawal from trial, loss of follow-up or death due to other reasons 11. Incomplete data, affecting effectiveness and safety judges 12. Researchers believe that the need for termination of the trial is needed
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Cirrhosis for EHM+ subjects Age between 18 and 70 (inclusive) Cirrhosis Minimal hepatic encephalopathy Expression of non opposition for EHM subjects Age between 18 and 70 (inclusive) Cirrhosis No hepatic encephalopathy (minimal or clinical) Paired with EHM+ subjects about age, gender, MELD score and cirrhosis etiology for all subjects Age older than 70 MMS score < 24 Clinical hepatic encephalopathy Cirrhosis etiology different from alcoholic, viral or metabolic one Intake of psychotropic drugs within 48h Alcohol intake > 30 g/j Heart, renal or respiratory failure Evolutive neurological diseases History of neurological diseases causing consequences
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 4.0-17.0, Type1diabetes Hypoglycemia Diagnosis of type 1 diabetes mellitus No diagnosis of type 1 diabetes mellitus
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-64.0, Diabetes Mellitus, Type 1 Male or female, Japanese subjects, aged 20 years (both inclusive) at the time of signing informed consent Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day Body mass index between 18.5 and 28.0 kg/m^2 (both inclusive) HbA1c less than or equal to 9.0% History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except conditions associated with diabetes mellitus) Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods Known or suspected hypersensitivity to trial products or related products
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Mellitus Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year Using an insulin pump for at least 3 months at the time of screening. Insulin pump use includes use of automated features, to predictive or threshold low-glucose suspend or hybrid closed-loop with without a Dexcom sensor Familiarity and use of a carbohydrate ratio for meal boluses Age ≥18.0 years old HbA1c < 10.5%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 weeks of the screening visit, the prior lab value may be used in lieu of repeating this assessment For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued Willingness to switch home pump to PLGS or full manual mode if using hybrid closed-loop with an FDA approved system Have an emergency contact living at home with the subject who will be available to be contacted by the study staff overnight in the event of an emergency Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, to having basic cooking equipment at home to prepare the study meals Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study Use of an unapproved closed-loop insulin delivery system within 2 weeks before screening or during the study is not allowed Gastrointestinal disease such as celiac disease or multiple food allergies Any form of gluten sensitivity or wheat allergy Allergies to any form of nuts or ingredients present in the study meals (tomatoes etc) History of difficulty digesting food Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) Hemophilia or any other bleeding disorder One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months Self-reported or clinically documented hypoglycemia unawareness
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 19.0-80.0, Hyperglycemia Age 19-80 years with fasting glucose 100-140 mg/dL Weight less than 48 kg or weight decreased by more than 10% within past 3 months Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months Blood sugar improvement or healthy functional food within past 1 month Under antipsychotic medication therapy within past 2 months History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test by show the following results aspartate aminotransferase, alanine aminotransferase > Reference range 3 times upper limit Serum Creatinine > 2.0 mg/dl
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 2 Diabetes Mellitus Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1) Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before screening visit (V1) Stable total daily basal insulin dose (±20 %) in the range of 10 and 25 U/day for at least 2 months before screening visit (V1). Total daily dose should be within the range of 10-25 U, both inclusive, on the day of screening, but individual fluctuations of ±20% within 2 months prior to screening are acceptable For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months prior to screening. The OAD(s) can be 1 to 2 out of Metformin (≥1500 mg/day or maximal tolerated dose) Sulfonylurea (SU)/glinide Alpha-glucosidase inhibitor (alpha-GI) Sodium-glucose co-transporter 2 (SGLT2) inhibitor Dipeptidyl-peptidase-4 (DPP-4) inhibitor Fasting plasma glucose (FPG) ≤160 mg/dL (8.9 mmol/L) at screening visit (V1) (can be repeated once to confirm) Age <18 years at screening visit (V1) Screening glycated hemoglobin A1c(HbA1c) <7.0% or >10.5% History of hypoglycemia unawareness History of metabolic acidosis, including diabetic ketoacidosis within one year prior to screening Use of oral or injectable glucose-lowering agents other than those stated in the within 3 months prior to screening Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin, within one year prior to screening (Note: Short term treatment [≤10 days] due to intercurrent illness is allowed) History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reason or lack of efficacy Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening Use of weight loss drugs within 3 months prior to screening Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 12.0-18.0, Type 1 Diabetes Mellitus for documented hyperglycemia (at least 1 must be met) Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required) Diagnosis of type 1 diabetes is based on the investigator's judgement for requiring insulin at diagnosis (both must be met) Daily insulin therapy for ≥ 6 months Insulin pump therapy for ≥ 3 months Age 12-18 years Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study Diabetic ketoacidosis in the past 6 months Hypoglycemic seizure or loss of consciousness in the past 6 months History of seizure disorder History of any heart disease including coronary artery disease, heart failure, or arrhythmias History of altitude sickness Chronic pulmonary conditions that could impair oxygenation Cystic fibrosis Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study History of ongoing renal disease (other than microalbuminuria) Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine)
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Mellitus Have been diagnosed with T1D and continuously using insulin for at least 1 year Have been using CSII therapy for a minimum of 6 months Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days Have hypoglycemia unawareness Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes > 18 years admitted to a general medicine or surgical service. 2. Known history of T1D or T2D receiving insulin therapy 3. Subjects must have a randomization BG between 140 mg and 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones). 4. Patients with expected hospital length-of-stay of 3 or more days Patients with acute illness admitted to the ICU or expected to require admission to the ICU. 2. Patients expected to require MRI procedures during hospitalization. 3. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 4. Female subjects who are pregnant or breast-feeding at time of enrollment into the study
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Pain Bariatric Surgery Candidate Adults age 18 and older eligible for bariatric surgery as per American Society for Metabolic and Bariatric Surgery guidelines BMI of at least 40, or greater than 100 pounds overweight BMI of 35 or above and at least one or more obesity-related comorbidity such as type II diabetes, hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, lipid abnormalities, gastrointestinal disorders, heart disease, or osteoarthritis Inability to achieve a healthy weight loss sustained for a period of time with prior weight loss efforts Age less than 18 Pregnant patients Patients with history of chronic pain Patients with diagnosed psychiatric disorders Patients actively taking pain medication before surgery Patients with prior surgical history
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-64.0, Hypoglycemia Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin via continuous subcutaneous insulin infusion. 2. Age 18 to < 65 years. 3. Duration of type 1 diabetes ≥ 2 years. 4. Random C-peptide < 0.6 ng/mL. 5. Using insulin therapy by continuous subcutaneous insulin infusion pump for at least 6 months. 6. History of exercise-related hypoglycemia. 7. Performs aerobic exercise regularly (2-3 times per week), and desires to exercise per American Diabetes Association guidelines (150 minutes per week). Examples of aerobic exercise power walking, hiking, running/jogging, cycling, swimming, cross country skiing, and aerobic fitness classes. 8. Will abstain from the use of non-insulin diabetes therapies such as sodium glucose co-transporter 2, glucagon like peptide-1, and metformin for the duration of the study. 9. Subject must be willing to adhere to the protocol requirements for the duration of the study. 10. Subject has provided informed consent as evidenced by a signed/dated informed consent form completed before any trial-related activities occur Frequently experience hyperglycemia with exercise, in the clinical judgement of the investigator. 2. Pregnant and/ or Nursing: For female subjects of childbearing potential, there is a requirement for a negative urine pregnancy test and for agreement to use contraception and to refrain from breast feeding during the study, and for at least 1 week after the last dose of study drug. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intra-uterine device, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. 3. One or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment). 4. Uses inhaled insulin. 5. Hemoglobin A1c > 9.0% at Screening. 6. Renal insufficiency (serum creatinine greater than 3 mg/dL (0.17 mmol/L)). 7. Serum alanine aminotransferase or aspartate aminotransferase equal to or greater than 3 times the upper limit of normal. 8. Hepatic synthetic insufficiency as defined as a serum albumin of less than 3 mg/dL (0.17 mmol/L); or serum bilirubin greater than 2 mg/dL (0.11 mmol/L). 9. Hematocrit of less than or equal to 30%. 10. Mean of triplicate blood pressure (BP) readings at Screening where systolic BP <90 or >150 mm Hg, or diastolic BP <50 or >100 mm Hg. 11. Clinically significant electrocardiogram abnormalities. 12. Use of > 2.0 U/kg total insulin dose per day. 13. Inadequate bilateral venous access in both arms. 14. Congestive heart failure, New York Heart Association class III or IV. 15. Active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. 16. Major surgical operation within 90 days prior to screening, or planned surgical operation during the study. 17. History of seizure disorders. 18. Current bleeding disorder, treatment with warfarin or any anticoagulants, or platelet count below 50,000. 19. History of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia type 2, neurofibromatosis, or Von Hippel-Lindau disease). 20. History of insulinoma. 21. History of allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products or to any of the excipients (dimethylsulfoxide, mannitol, & trehalose) in the investigational formulation. 22. History of glycogen storage disease. 23. Subject tests positive for human immunodeficiency virus, hepatitis C virus, or active hepatitis B virus infection at Screening. 24. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. 25. Active substance or alcohol abuse, in the opinion of the investigator. Subjects reporting active marijuana use or testing positive for tetrahydrocannabinol via rapid urine test will be allowed to participate in the study at the discretion of the investigator. 26. Participation in other studies involving administration of an investigational therapeutic agent (drug or device) within 30 days or 5 half-lives, whichever is longer, before Screening for the current study and during participation in the current study. 27. Any reason the investigator deems exclusionary
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus Males and females ≥ 18 years admitted to a general medicine or surgical services. 2. History of T1D or T2D receiving insulin therapy during hospital admission. 3. Subjects must have a randomization BG <400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones). 4. Patients with expected hospital length-of-stay of 3 or more day Patients with acute illness admitted to the ICU or expected to require admission to the ICU. 2. Patients expected to require MRI procedures during hospitalization. 3. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema). 4. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 5. Female subjects who are pregnant or breast-feeding at time of enrollment into the study
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Mellitus Age >18 years T1DM Good general health Fasting C-peptide concentration <0.7 ng/ml Poor glycemic control (HbA1c=7.0-11.0%) Treatment with multiple daily insulin injections or insulin pump Total daily insulin dose ≥0.6 U/kg per day Stable insulin dose (±4 units) in the preceding three months eGFR≥60 ml/min Weight stable over the preceding 3 months (± 3 pounds) T2DM Daily insulin dose <0.6 U/kg per day Fasting C-peptide >0.7 ng/ml HbA1c <7.0% or >11.0% eGFR<60 ml/min Hematuria in urine analysis Pregnancy, lactating, positive pregnancy test or planning to become pregnant in the following year Women of child-bearing potential will be requested to use at least two barrier methods before being enrolled in the study Major organ system disease which includes: (i) malignancy or history of malignancy including bladder cancer; (ii) Congestive heart failure or history of coronary heart disease or any other cardiac disease; (iii) chronic liver disease or LFT >3 times the upper normal level; (iv) History of alcohol or drug abuse; (v) History of chronic lung disease (e.g., COPD, asthma); (vi) history of rheumatic disease; (vii) History of chronic pancreatitis or pancreatic surgery; (viii) History of CVA or TIA (ix) Planned surgery during the study; (x) history of HIV infection or other immune compromised disease; and history of organ transplantation; (xi) patients who take medications, other than insulin, known to affect glucose metabolism, e.g., prednisone Evidence of proliferative diabetic retinopathy
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hypertension Diabetes Obesity Kidney Diseases Dyslipidemias Smoking Alcohol Use, Unspecified Physical Inactivity Poor Diet Inflammation Myocardial Infarction Heart Failure Stroke Cardiac Death age > or = 18 years, primary residence in the study area of Port-au-Prince (defined as having slept at the household at least once in the past two weeks and considers the household their primary residence with no plans to move in the next 24 months) able to provide consent for study procedures agrees to study procedures, and willing to be contacted at a new residence if a move occurs serious medical conditions or cognitive impairment preventing study participation as judged by research physicians unable to speak and understand French or Creole
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus Physical Activity Dietetic Rules Therapeutic Education Patient with type 2 diabetes defined by (HAS 2013) a blood glucose level above 1.26 g / l (7.0 mmol / l) after an 8-hour fast and checked twice or the presence of symptoms of diabetes (polyuria, polydipsia, weight loss) associated with blood glucose (on venous plasma) greater than or equal to 2 g / l (11.1 mmol / l) or blood glucose (on venous plasma) greater than or equal to 2 g / l (11.1 mmol / l) 2 hours after an oral load of 75 g of glucose (criteria proposed by the World Health Organization). 2. Patient with HbA1c at inclusion> 7 and <12% (on an HbA1c dose less than 6 months old at the prescreening) 3. Patient with a BMI ≥ 25 and a weight ≤ 125 kg 4. Patient with appropriate treatment 5. Age ≥ 18 years 6. Available to go on treatment in 6 weeks after 7. Available for a 12-month follow-up 8. Affiliated to the social security or beneficiary of such a scheme Diabetes type 1 or secondary 2. Patient with GFR (glomerular filtration rate) <50 ml / min (MDRD formulation) for at least 1 year. 3. Unstable diabetes defined by the knowledge of the questioning of a change in HbA1c of +/ in the last 6 months. 4. With known serious comorbidity and / or limited life expectancy (<5 years), or with advanced macrovascular complications: in particular cardiovascular (acute coronary diseases and / or stroke in the last 6 months) and renal 5. Severe psychiatric pathology or psychosis 6. Pregnant woman, parturient or breastfeeding 7. Contraindication to hydrotherapy 8. Patient with a contraindication to moderate physical activity or cycling (acute coronary artery disease less than 2 years old, musculoskeletal problem of the spine or lower limbs incompatible with cycling). 9. No previous spa treatment for "Digestive disorders and metabolic diseases" in the current the spa year. 10. Person deprived of liberty or legal protection measure 11. Subject participating to an other clinical study interventional
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 16.0-35.0, Type 1 Diabetes Mellitus Diagnosis of Type 1 Diabetes according to the American Diabetes Association for a period less than four months Pancreatic Autoimmunity (positive anti-glutamic acid decarboxylase [GAD]; and/or Islet antigen 2 [anti-IA2]) Clinical evidence of malignancy or prior history Pregnancy or desire to become pregnant within 12 months of the study Breastfeeding HIV(+), Hepatitis B (+), Hepatitis C(+) Diabetic ketoacidosis at diagnosis Glomerular filtration rate less than 60ml/min Use of immunosuppressors or glucocorticoids
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-69.0, Diabetes Mellitus, Type 2 Have Type II diabetes Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive Have a body weight of <150 kilograms (kg) Have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, CK values within the normal range at screening and Day -2 Have Type 1 diabetes or latent autoimmune diabetes in adults Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening Have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Visit 1 Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis Have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening Have an estimated glomerular filtration rate <45 milliliters per minute per 1.73 meters squared of body surface area (mL/min/1.73 m²)
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.0-999.0, Lipodystrophy Acquired Type1diabetes Meet the diagnostic of type 1 diabetes mellitus: clinical manifestations of typical diabetes mellitus polyphagia, polyuria, weight loss, or diabetic ketoacidosis, confirmed by blood sugar level, islet function and autoimmune antibody. 2. Meet the diagnostic for panniculitis: fat biopsy suggests inflammatory infiltration. 3. Meet the diagnostic for acquired lipodystrophy syndrome: childhood onset, clinically no nutritional deficiency or catabolism, systemic or partial subcutaneous fat reduction, genetic testing to congenital lipodystrophy syndrome; low leptin level and autoantibodies can aid in diagnosis Mature and effective treatment methods are available. 2. HIV, HBV and HCV were positive. 3. A the active period of infection. 4. At the active stage of malignant tumors. 5. Combination of other fatal diseases. 6. Existence of mental and psychological diseases
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 6.0-40.0, Injection Reactions Site Systemic Reactions Patients older than 6 years old who received SCIT at Pediatrics allergy departments at Siriraj hospital Patients who develops larges local reactions(mean wheal diameter > 25 mm.) during SCIT Patients who received SCIT in maintenance phase Patients who develops systemic reactions (more than grade 1) during SCIT
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Transplanted Kidney Complication Hyperglycemia (glucose levels above 140 mg/dl) immediately after renal transplantation Incomplete records on the patients file Acute complications such as liver failure
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.833-35.0, Autism Spectrum Disorder Diagnosis of autism spectrum disorder 2. Child between the ages of 24-60 months 3. First born child 4. No physical or medical conditions that affect the child's ability to participate in the activities that are part of the intervention process 5. Ability to follow simple verbal directions in English 6. No current plan to initiate any treatment alternatives during the study period 7. Willingness to participate in a -week intervention with a frequency of once a week 8. Adults are primary caregiver 9. Under age of 35 10. Speak English 11. Minimum grade 5 schooling 12. Access to a computer and broadband wired or wireless (3G or 4G/LTE) internet connection? Participants (both child and adult) will be excluded from the present study if they were deemed low functioning child is not the first-born child child already receiving ABA treatment parents have a history of mental illness
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes • At the baseline visit, European American and African American individuals with T2D must have had diabetes diagnosed after the age of 30, 3 years disease duration and lack historical evidence of diabetic ketoacidosis At the baseline visit, participants with pre-existing kidney disease, defined as a serum creatinine concentration >1.5 mg/dl or blood urea nitrogen >35 mg/dl were excluded due to the elevation of serum AGE levels in individuals with kidney disease
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Type 1 Diabetes Male and female subjects age 18 to 70 years of age. 2. Subjects who are able to provide written informed consent and to comply with study procedures. 3. Clinical history compatible with Type 1 diabetes (onset < 40 yrs old and insulin dependent for > 5 yrs at enrollment, c-peptide negative). 4. Recipients should have absent stimulated c-peptide (< 0.3 ng/mL) in response to a (Boost® 6 mL/kg BW to a maximum of 360 mL; another equivalent product), measured at 60 and 90 min after start of consumption. 5. Subjects who are > 6 months post-renal transplant or >6 months post-liver transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression ([tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic, or azathioprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic ± Prednisone ≤ 10 mg/day). 6. Stable renal function as defined by a creatinine of no more than one third greater than the average creatinine determination performed in the 6 previous months prior to islet transplant, as well as absence of a rejection episode in the 6 months prior to islet transplant 7. Stable liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values < 1.5, or total bilirubin < 1.5 times normal upper limits at time of study entry, as well as absence of a rejection episode in the 6 months prior to islet transplant Presence of donor specific anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross match 2. Insulin requirement of >1.0 IU/kg/day 3. Weight more than 100 kg or body mass index (BMI) > 30 kg/m2. 4. Primary hyperparathyroidism OR secondary hyperparathyroidism 5. Untreated or unstable proliferative diabetic retinopathy. 6. Blood Pressure: SBP > 180 mmHg or DBP >100 mmHg despite treatment with antihypertensive agents. 7. Calculated GFR of ≤ 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation, as well as presence of a rejection episode in the 6 months prior to islet transplant 8. Elevated liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values > 1.5, or total bilirubin >1.5 times normal upper limits at time of study entry, as well as presence of a rejection episode in the 6 months prior to islet transplant 9. Proteinuria (albumin/creatinine ratio or ACr > 300mg/g) of new onset since kidney transplantation. 10. For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. 11. Active infection including hepatitis B, hepatitis C, HIV, or TB. A positive skin test (PPD) in itself is not an and will be followed up by a Quantiferon gold assay. 12. Negative screen for EBV IgG. 13. Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within 1 year prior to study entry. 14. Any history of malignancy following receiving either the kidney or liver transplant, except for completely resected squamous or basal cell carcinoma of the skin 15. Known active alcohol or substance abuse. 16. Severe co-existing cardiac disease, characterized by any one of these conditions: 1. Recent MI (within past 6 months), 2. Evidence of ischemia on functional cardiac exam within the last year, 3. Left ventricular ejection fraction < 30%, 4. Valvular disease requiring replacement with prosthetic valve. 17. Active infections (except mild skin and nail fungal infections). 18. Active peptic ulcer disease or gastritis, symptomatic gallstones, or portal hypertension. 19. Use of any investigational agents within 4 weeks of enrollment. 20. Administration of live attenuated vaccine(s) within 2 months of enrollment. 21. Any medical condition that, in the opinion of the investigator, will interfere with safe study completion. 22. Positive screen for BK viremia at time of screening. 23. Untreated hyperlipidemia TC > 200 mg/dL, TGC > 200 mg/dL, LDL > 130 mg/dL
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-999.0, Epidural Localization years and older Surgery requiring epidural anesthesia or analgesia ASA Physical Status 1 to 3 Bleeding and clotting disorders Platelet count < 100,000 / mm3 International normalized ratio (INR) > 1.5 History of peripheral neuropathy Neuromuscular or neuropsychiatric disease Marked spinal deformities or a history of spinal instrumentation Systemic infection Skin infection at the injection site Significant heart failure, e.g. New York Heart Association (NYHA) Functional Classification 3 or 4
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-75.0, Hepatic Encephalopathy Acute-On-Chronic Liver Failure Age 18-75 years Patients with ACLF with presence of hepatic encephalopathy > grade 2 as per WHC Pregnant women or those who are suspected to be having acute fatty liver of pregnancy Malarial hepatopathy, enteric hepatitis, or ischemic hepatitis Serum Na <125 mEq/litre Gastrointestinal (GI) obstruction, ileus, or gastric retention Bowel perforation Toxic colitis or toxic megacolon Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam) Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy Uncontrolled infection with hemodynamic instability requiring vasopressors
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Asthma Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects aged 18 to 65 years (inclusive) at the Screening Visit, with suitable veins for repeated venipuncture. 3. Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit (Day 1) and must not be lactating. 4. Females of childbearing potential who are sexually active must use a highly effective method of contraception from the Screening Visit and must agree to continue using such precautions for 16 weeks after the dose of Investigational Medicinal Product (IMP). Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. 5. Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 90 kg inclusive. 6. Intact normal skin without potentially obscuring tattoos, scars, pigmentation or lesions on the skin area intended for injection (abdomen, thigh, upper arm) History of any clinically significant disease or disorder. 2. History of anaphylactic reaction to biologic therapy. 3. Acute upper or lower respiratory infection requiring antibiotics or antiviral medications. 4. History of tuberculosis. 5. History of known immunodeficiency disorder, including a positive human immunodeficiency virus, or the subject is taking antiretroviral medications. 6. Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to the Screening Visit. 7. Current smokers or those who have smoked or used nicotine products including e-cigarettes within the 3 months prior to the Screening Visit. 8. History of cancer: Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the Screening Visit. Subjects who have had other malignancies including breast cancer are eligible provided that curative therapy was completed at least 5 years prior to the Screening Visit. 9. Subjects who have previously received tezepelumab
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.5-18.0, Type1diabetes Type 1 diabetes de novo according to American Diabetes Association 1. Polyuria, polydipsia, weight loss ± ketoacidosis 2. Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at the 120th minute of an Oral Glucose Tolerance Test (OGTT) AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg/dL. 3. Presence in the serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8) 2. Age between 6 months and 18 years. 3. Male or female. 4. Positive for one or more autoantibodies typically associated with Type 1 Diabetes (TD1). 5. Free written and oral consent Children under 6 months of age. 2. Treatment that interferes with insulin secretion and insulin sensitivity (e. g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins). 3. Presence of celiac disease (diagnosis based on pathological duodenal biopsy), recently diagnosed (within 1 month), at the time of inclusion. 4. Autoimmune/auto-inflammatory disease (other than type 1 diabetes) or active malignant disease present at inclusion. 5. Obesity defined by a Body Mass Index (BMI) with a z-score >+3 Standard Deviation. 6. Hepatic, renal or adrenal insufficiency. 7. History of spinal cord allograft. 8. History of post-hemolytic-uremic diabetes. 9. Absence of anti-pancreatic islet auto-antibodies. 10. Dysmorphic with suspicion of underlying genetic syndrome. 11. Participation in another study within the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperglycemia Diabetes Mellitus Male or Female, ≥ 18 years of age. 2. Subject able to provide written informed consent to participate in the study. 3. Female subject with a negative urine or serum pregnancy test, or not of childbearing potential, defined as surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy; or are postmenopausal for at least 1 year. 4. Have a blood sugar value of >140 mg/dL or an glycosylated hemoglobin A1C (HbA1C) values >6.5% upon admission to the surgical Intensive Care Unit (ICU), medical ICU, or cardiovascular ICU, and have or not have been diagnosed with type 1 or type 2 diabetes Subjects younger than 18 years old. 2. Subjects who are prisoners. 3. Subjects with known hypersensitivity to latex or tape. 4. Females who are pregnant or breastfeeding. 5. Subjects unable to provided informed consent. 6. Subjects unable to participate in the study for any reason in the opinion of the Principal Investigator. 7. Subjects enrolled in other research studies
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 19.0-999.0, Type2 Diabetes Individuals > 18 years of age 2. Self-reported Latino heritage 3. Fluent in Spanish 4. Type 2 diabetes diagnosis 5. Available to attend the educational series and all study visits 6. Willingness to have height, weight, waist circumference, and HbA1c measured before and after the educational course 7. Individuals with poor glycemic control, as defined by the following HbA1c ≥ 8% at or prior to enrollment assessment (most recent lab within 3 months or provided at Sansum Diabetes Research Institute (SDRI) screening visit), OR HbA1c < 8% (within the last 3 months), AND with at least one of the following (also within the last 3 months) Fasting plasma glucose ≥ 130 mg/dL hour post-prandial or random blood glucose ≥ 180 mg/dL ≥1 hypoglycemic event (blood glucose < 70 mg/dL) OR Individuals new to insulin or being considered for insulin therapy by their healthcare provider 8. Willing and able to provide consent to take part in the study 9. Based on the research staff's judgment, participant must have a good understanding, ability, and willingness to adhere to the protocol Has a cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, medical condition, or insufficient knowledge of the education program language that, in the opinion of the screener, would interfere with the ability to provide consent and participate/complete the program 2. Participation in other studies involving medications or device within 3 months prior to Visit 1 3. Known or suspected abuse of alcohol, narcotics, or illicit drugs 4. Current use of insulin pump 5. For females: Pregnancy or positive pregnancy test 6. Pharmaceutical employees or those employed in a position where they have a direct role in treating participants with diabetes
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperglycemia Steroid-induced Hyperglycemia Stress Surgery--Complications All embedded head and neck-surgical patients receiving large packs of pre-medication, including 8-16 mg glucocorticoid >18 yrs Expected admission time of a minimum of 1 day Patients who do not understand and / or speak Danish Patients who are demented Patients included in primary robot surgery Ear-surgical patients Sinus surgery patients Day surgery patients Plastic surgical patients Patients who are scheduled to transfer to ICU Patients with Diabetes Mellitus type I Patients on dialysis
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 1 Diabetes The subject has type 1 diabetes as defined by WHO 2. The subject is 18 years of age or older 3. The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting 4. The subject is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro or Insulin Glulisine) 5. HbA1c <10% (86mmol/mol) for phase 3, based on analysis from central laboratory or equivalent 6. The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 2 measurements per day 7. The subject is willing to wear closed-loop system at home and at work place 8. The subject is willing to follow study specific instructions including the use of bolus calculator for all meals / snacks 9. The subject is willing to upload pump and CGM data at regular intervals 10. Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening Non-type 1 diabetes mellitus 2. Subjects who are living alone 3. Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results 4. Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator 5. Known or suspected allergy against insulin or previous reaction to FiAsp 6. Subjects with clinically significant nephropathy (eGFR < 45ml/min), neuropathy or active retinopathy (defined as presence of maculopathy or more than background diabetic retinopathy changes) as judged by the investigator 7. More than one episode of severe hypoglycaemia as defined by American Diabetes Association (42) in preceding 12 months (Severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions including episodes of hypoglycaemia severe enough to cause unconsciousness, seizures or attendance at hospital.) 8. Total daily insulin dose > 2 IU/kg/day 9. Subject is pregnant or breast feeding or planning pregnancy within next 10 months 10. Severe visual impairment 11. Severe hearing impairment 12. Lack of reliable telephone facility for contact 13. Subject not proficient in English (UK), French (Switzerland) or German (Germany, Switzerland and Austria) Additional specific for Austria 1. Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). 2. Positive alcohol breath test. 3. Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-100.0, Abdominal Injury Thoracic Injury Hyperglycemia Hyperglycemia Stress adult patients with moderate to severe thoracoabdominal injuries patients with a thoracic and abdominal abbreviated injury scale (AIS) < 3 patients who had polytrauma which was defined as there was additional AIS scores ≥ 3 points in other regions of the body patients less than 20 years old patients who had sustained a burn injury
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 1 Diagnosis of Diabetes Mellitus type 1 for at least 12 months Multi-injection insulin therapy C-peptide <0.2 nmol/L At least 1 documented episode in the last 12 months of hospitalization (emergency room or ordinary hospitalization) for severe hypoglycemia; hospitalization (emergency room. or ordinary hospitalization) for diabetic ketoacidosis; documented severe hypoglycemia (i.e. with blood glucose measurement) Diabetes Mellitus type 2 Other types of diabetes Other diseases (excluding endocrinopathies, hypertension and dyslipidemia) that required chronic intake of drugs that may interfere with the glucose-insulin system
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-90.0, Type 1 Diabetes Hyperglycemia, Postprandial persons with T1D for >5 years age >18 HbA1c <9.5% Patients using either MDI or insulin pumps will be included Patients using CGM will continue the use during the study, however glucoses will be measured by laboratory methods Persons of all races, ethnicity and genders will be included Participants should have normal hemoglobin, hematocrit and eGFR >60 ml/min/1.73m2 Persons with type 2 diabetes, monogenic diabetes, pancreatic diseases Pregnancy, prisoners, other vulnerable populations or persons unable to understand the protocol and provide written informed consent Persons who take daily steroids, any route, for any purpose
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-35.0, Medication Adherence university students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences age <18 years or inability to sign informed consent
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus S/he is above the age of 18 2. S/he has the ability to read, speak and write English 3. S/he has telephone access 4. S/he is diabetic and willing to check blood sugar levels every day 5. Hb A1c >7% 6. Possesses a glucometer Allergy to kombucha ingredients 2. Drinks kombucha regularly (>3time per week)
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-80.0, Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Gestational Diabetes Mellitus Pancreatogenic Diabetes Mellitus Pregestational Diabetes Mellitus Diabetes Patients in Perioperative Period Patients in clinic of type 1 diabetes mellitus, type 2 diabetes mellitus, gestational/pregestational diabetes mellitus, perioperative diabetes mellitus and patients with diabetes mellitus after pancreatectomy, including those with poor blood glucose control using multiple subcutaneous insulin injections or those are willing to use insulin pump therapy; 2. Age: 18-80 years old; 3. Patients and family members understand the research program and are willing to participate in the study and sign written informed consent allergic to dressings and subcutaneous transfusion tubes; 2. allergic to insulin; 3. Severe diabetic acute complications within 6 months(diabetic ketoacidosis, diabetic hyperglycemia and hyperosmolar state, diabetic lactic acidosis). 4. Severe chronic complications of diabetes mellitus, such as peripheral vascular lesions leading to amputation or chronic foot ulcer, end-stage renal disease, etc. who researchers thought not suitable for this study. 5. Two or more times of severe hypoglycemia occured in the past year (such as consciousness disturbance and coma caused by hypoglycemia), or severe unconscious hypoglycemia. 6. Patients with severe impairment of cardiac function (NYHA grade III or above), liver function (alanine aminotransferase, aspartate aminotransferase or total bilirubin higher than the upper limit of normal value 2 times or more), renal function (serum creatinine higher than the upper limit of normal value) or circulation disorder; 7. Patients with mental illness and self-care ability; 8. Patients or their families could not understand the conditions and objectives of this study
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year Using an insulin pump for at least 3 months at the time of screening. Insulin pump use includes use of automated features, to predictive or threshold low-glucose suspend or hybrid closed-loop with or without a Dexcom sensor Familiarity and use of a carbohydrate ratio for meal boluses Age ≥18.0 years old HbA1c < 10.5%, as performed by point of care or central laboratory testing. HbA1c will be assessed at the screening visit, or if already completed within 2 weeks of the screening visit, the prior lab value may be used in lieu of repeating this assessment For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study and up to one month afterwards. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued Willingness to switch home pump to PLGS or full manual mode if using hybrid - Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial Use of an unapproved closed-loop insulin delivery system within 2 weeks before screening or during the study is not allowed Have a blood pressure at screening outside the range of 160 mmHg systolic blood pressure and/or greater than 100 mmHg for diastolic blood pressure (if repeated measurements are within this range, the patient may be included in the study) Have coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) Hemophilia or any other bleeding disorder A condition, which in the opinion of the investigator or designee, would put the participant or study at risk, to Pregnancy, or planning pregnancy within 1 month of completing the clinical trial Allergy or hypersensitivity to hydrocortisone, or any component of the formulation Presence of a known adrenal disorder Systemic fungal infections
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-70.0, Diabetes Mellitus, Type 2 Have T2DM for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus Have a glycated hemoglobin (HbA1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening Have had a stable body weight for the 3 months prior to randomization (<5% body weight change) Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive Male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose Women not of childbearing potential may participate and those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or those who are postmenopausal Have type 1 diabetes mellitus or latent autoimmune diabetes in adults Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening Have a known clinically significant gastric emptying abnormality Have had an episode of severe hypoglycemia Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligrams per deciliter (mg/dL) at screening and/or Day-2. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3X upper limit of normal (ULN) at screening and/or Day -2
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 50.0-85.0, Diabetes Mellitus, Type 2 HbA1c higher than 6.8% or fasting blood sugar higher than 126mg/dL Conscious, mental and cognitively normal no obstacles in action can read, write and communicate with mandarin, taiwanese and hakka Inflammatory skin wounds on the neck, back, lower back or lower leg obstacles in communication People with disabilities, epilepsy, and other unacceptable warming treatments When the subject finds that he or she is unwell during the procedure, the experiment is terminated and take care by the medical staff
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 1.5-999.0, Diabete Type 1 Diabete Type 2 Patient At least 18 years old Diagnosed with type 1 or type 2 diabetes according to HAS and confirmed by and endocrinologist since at least one year Having had at least one consultation with a health care professional in the last 12 months Able to communicate in French Able to participate in an interview and not opposing to participate in the study Professional Having at least one year of professional experience in diabetes care General practitioner, endocrinologist, diabetologist, intern, nurse, nutritionist or professional specialized in therapeutic education Patient Inability to communicate in French Institutionalized person Professional Professional not having had at least one consultation with a person living with diabetes in the last 12 months
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 2 Veterans active VHA patients with type 2 diabetes have had at least 4 VA outpatient encounters in the previous year have a future appointment scheduled, and not be hospitalized or institutionalized or have participated in Aim 1 DD-TXT development must have access to their own or a cohabiting family member's cell phone or smartphone for participation. --must be willing and able to text, not have any visual impairment that would prevent them from reading or replying to text messages, and must be cognitively capable of consent to participate must also have HbA1c lab data (2+ values) for the 12 months prior to RCT recruitment must have inadequate glycemic control for at least 50% of the 6 months before enrollment -Non-Veterans
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Helminthiasis Helminth Infection The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. The only clinical criterion for his in the study was that he was healthy N/A
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-45.0, Type 1 Diabetes Diabetic Ketoacidosis Provision of informed consent from participant and all legal representatives prior to any study specific procedures 2. Age: Female and/or male aged >18 years 3. Subject must have type 1 diabetes (as diagnosed clinically) ≥ 12 months 4. HbA1c <10 % 5. Insulin use with an average daily dose between 0.6 0 U/kg administered by insulin pump (CSII) 6. BMI 23.0 to 35.0 kg/m2 minimum weight of 50 kg 7. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study as judged by the investigator 8. WOCBP must have a negative serum pregnancy test at screening as well as negative urine tests at follow up visits 9. Women must not be breastfeeding Target Disease Exclusions 1. History of T2DM (type 2 diabetes mellitus), maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis 2. Any use of oral hypoglycemic agents within 2 weeks prior to the screening visit 3. History of diabetes ketoacidosis (DKA) within 12 weeks prior to prior to the screening visit 4. History of diabetes insipidus 5. History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 3 months prior to prior to the screening visit 6. Frequent episodes of hypoglycemia as defined by more than one episode requiring assistance, emergency care (paramedics or emergency room care) or glucagon therapy (in children defined as seizure or loss of consciousness) , or more than 2 unexplained episodes of symptomatic hypoglycemia within 3 months prior to the screening visit. An unexplained event is defined as an event that cannot be explained by circumstances such as dietary (e.g. missed meal), strenuous exercise, error in insulin dosing, etc. 7. Hypoglycemic unawareness 8. History of Addison's disease or chronic adrenal insufficiency 2. Physical and Laboratory Test Findings 1. Random C-Peptide >0.5 nmol/l 2. Aspartate aminotransferase (AST) > 2X Upper limit of normal (ULN) 3. Alanine aminotransferase (ALT) > 2X ULN 4. Serum total bilirubin > 2X ULN (except known Gilbert's disease) 5. Creatine kinase (CK) > 3X ULN 6. Estimated GFR (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula ≤ 60 ml/min/1.73m2. The renal function, eGFR will be estimated by the abbreviated MDRD, using laboratory measurements of serum creatinine collected at screening 7. Hemoglobin ≤ 11.0 g/dl (110 g/l) for men; hemoglobin ≤10.0 g/dl (100 g/L) for women. 8. Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody or HIV in patient's history. 9. Abnormal Free T4 Note: abnormal TSH value at screening will be further evaluated for free T4.Subjects with abnormal free T4 values will be excluded. A one-time retest may be allowed, as determined by the Investigator, after a minimum of 6 weeks following the adjustment of thyroid hormone replacement therapy in subject who have had a prior diagnosis of a thyroid disorder and who are currently receiving thyroid replacement therapy. Such cases should be discussed with the Sponsor prior to re-testing. The subject must have all screening procedures and laboratory assessments performed as part of this re-test, and all of these must meet enrolment criteria. The subject's number will, however, remain the same as initially assigned
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to drug
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 2 Diabetes self-reported Marshallese years of age or older have T2D (defined as having an HbA1c equal to or greater than 6.5) have at least one family member willing to take part has received DSME in the past five years has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder plans to move out of the geographic region
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-64.0, Diabetes Mellitus, Type 1 Male or female participants with type 1 diabetes Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%) Using CSII and stable insulin regimen for at least 3 months prior to into the trial Known or suspected hypersensitivity to investigational medical product(s) or related products Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination Widespread subcutaneous lipodystrophy in the abdomen Current use of any glucose-lowering agents other than insulin within 3 months prior to screening Chronic or recent use of corticosteroids
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Insulin Resistance Non-Alcoholic Fatty Liver Disease Body mass index (BMI) >24.9 kg/m2, If participant is included during COVID19-pandemic, maximum BMI is 32 kg/m2 Haemoglobin ≥7.5 mmol/l Written informed consent If the participant is screened during COVID19, extra is age>59 years. If the participant is screened during COVID19-pandemic, following is also applicable: 1) Diagnosed with asthma requiring medication or having uncontrolled asthma. 2) Beeing a current smoker. 3) diagnosed with hypertension. 4) having a job or engaging in daily activities, where it is not possible to adhere to the required distance of one meter to other people, judged by the investigator. 5) bA1c above 42 mmol/mol at screening Use of glucose-lowering drugs, lipid-lowering drugs, warfarin, clopidogrel or non-vitamin K anti-coagulants Frequent use of anti-inflammatory drugs the last two months prior to judged by the investigator Treatment with drugs with potential steatogenic side-effects within two months prior to Use of medication known to interact with prednisolone Use of curcumin-containing food supplements or other natural products that could cause confounding as evaluated by investigator Any regular drug treatment that cannot be discontinued for minimum 18 hours Previous diagnosis of T2D
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 12.0-15.0, Type 1 Diabetes Age 12 years (between their 12th and 16th birthday at recruitment) Type 1 diabetes diagnosed for at least 6 months Group 1: HbA1c <58mmols/mol on last known test Group 2: HbA1c ≥75mmols/mol and <100mmols/mol on last known test Willing to participate in group interview with at least one parent/carer Family currently identified as not suitable for lone visits Participants with inadequate English to take part in a semi-structured interview conducted in English Children and Young people for whom the last HbA1c incongruent with their previous results will be excluded
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-75.0, Diabetes Mellitus, Type 2 People with T2DM and follow up at private general practitioner 2. Age 18-75 3. Haemoglobin A1c (HbA1c) >7.0% 4. Can communicate in Cantonese Insulin users 2. Unstable emotional and/or mental status 3. Cognitive impairment and/or learning disabilities 4. Recruited in other research and/or diabetes educational programme during the study period
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 14.0-999.0, Type1diabetes Fasting Insulin DM type 1 2. Age > 14 years 3. Diagnosis of type 1 DM of more than 6 months. 4. Committed to do SMBG Renal and hepatic impairment 2. Adrenal insufficiency 3. Pregnancy 4. Alcohol consumption 5. Any diagnosed psychiatric disease
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-80.0, Heart Failure Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no prespecified criterion with respect to heart failure etiology and/or ejection fraction Other etiologies of fluid overload different from heart failure. 2. Hyponatremia: Sodium level below 125mmol/l 3. Unstable patients: acute coronary syndrome, cardiogenic shock . 4. Patients requiring inotropic agents or renal dialysis. 5. Pregnancy or breastfeeding period. 6. sever hepatic disease 7. GFR is less than 45 mL/min/1.73 m² . 8. Patient with diabetic ketoacidosis or non ketotic hyperosmolar
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, type1diabetes Hunger Obesity Type 1 diabetes BMI >30 kg/m2 for the obese groups Diabetic neuropathy Malignancy
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year Using an insulin pump for at least 3 months (which may use of automated features) Familiarity and use of a carbohydrate ratio for meal boluses Age ≥18.0 years old For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued If using a personal CGM, willingness to use a Dexcom G6 CGM and discontinue personal CGM use during the study Willing not to begin use of, or not to continue use of if currently using, a personal AID (closed loop control) system during the study; note if the system offers an open-loop mode or can be switched to a PLGS mode that is compatible with the Dexcom G6, the system may be used during the study in these modes only Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial, and not to use Afrezza during the trial Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol Use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless participant is willing to discontinue during the trial Two or more episodes of DKA requiring an emergency room visit or hospitalization in the past 6 months Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in the last 6 months Hemophilia or any other bleeding disorder A medical or other condition that in the opinion of the investigator could create a safety concern for the participant or put the study at risk. History of frequent severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis, without emergency room visit or hospitalization, due to poor diabetes self-management may be disqualifying per investigator judgment Participation in another pharmaceutical or device trial at the time of enrollment or during the study
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Mellitus Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year Participants must have been using multiple daily injections without interruption for at least 3 months Participants must have HbA1c values of 5.6% to 9.5%, inclusive Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²) Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke) Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m² Have active or untreated cancer Are receiving chronic (>14 days) systemic glucocorticoid therapy
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 21.0-80.0, Type 2 Diabetes Treated With Insulin English-speaking 2. Males and female adult subjects admitted to Boston Medical Center to a medical or surgical floor. 3. Consultation by the Inpatient Diabetes Service at Boston Medical Center is required prior to consent. 4. Age ≥ 21 and <= 80 years. 5. Diagnosed with type 2 diabetes at least 180 days prior to screening. 6. Hyperglycemia during admission, as defined by a point of care and/or venous blood glucose ≥ 140 mg/dL. 7. Prior to admission subjects must be using one of the following for outpatient diabetes management: 1. Insulin 2. ≥ 2 oral/injectable agents 3. One oral/injectable agent with a hemoglobin A1c of ≥ 8% within 3 months of enrollment. 8. Patients who are expected to remain hospitalized for a minimum of 48 hours following CGM sensor placement. 9. BMI <45 kg/m^2. 10. Subjects must have insulin glargine dosing planned at bedtime for the duration of the study period. Morning and afternoon dosing of insulin glargine are exclusionary Patients with a history of type 1 diabetes or late-onset autoimmune diabetes (LADA). 2. Treatment or plan for treatment with glucocorticoids during the index hospitalization. 3. Female patients who are pregnant (tested during hospitalization or screening) or breast-feeding during the hospitalization. 4. Patients admitted with the following conditions: diabetic ketoacidosis, hyperosmolar hyperglycemic state, solid organ transplantation, or coronary artery bypass surgery. 5. Prior diagnosis of gastroparesis or cirrhosis. 6. Acute or chronic kidney disease with a serum creatinine of ≥ 2 mg/dL at the time of screening. 7. Clinically significant nausea and/or vomiting or unable to consume more than 30 grams of carbohydrate at each meal. 8. Patients expected to receive nothing by mouth (NPO) for >24 hours. 9. Use of continuous or intermittent enteral feeding or parenteral nutrition. 10. Patient receiving aspirin and/or vitamin C during the hospitalization. 11. Any mental condition rendering the subject unable to provide informed consent. 12. Patients currently incarcerated. 13. Patients using >1 unit/kg/day of insulin prior to admission. 14. Insulin pump usage within the 2 weeks prior to or during admission. 15. Patients currently using real-time continuous glucose monitoring (CGM) or personal flash glucose monitoring system (FGM). 16. Patients with a history of an allergy to any of the types of insulin or one of the excipients in the insulin used in the study
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.0-22.0, Respiratory Diseases Neurological Disorders Type 1 Diabetes Age 0 ≤ 22 years at study entry and signed informed consent Additional for respiratory disease population Acute disease Acute signs for a respiratory disease, indicated by e.g. increased work of breathing (e.g. dyspnea, increased respiratory rate), cough or wheezing Chronic disease Suspected or confirmed chronic airway disease (e.g. asthma). Additional for neurological disease population Acute disease Acute presentation or report within 24 hours of any signs of neurological deficit (motor function, sensoneural, or verbal) Chronic disease Confirmed chronic neurologic disease (e.g. childhood epilepsy). Additional for T1D disease population Acute disease Physical or intellectual impairment precluding protocol adherence. Additional for respiratory disease population Known malignancy, active smoker (passive smoke exposure is not an criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and/or pharmacological treatment and is associated with an inflammatory response, relevant congenital defects Additional for neurological disease population Known malignancy, active smoker (passive smoke exposure is not an criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and/or pharmacological treatment and is associated with an inflammatory response, relevant congenital defects. Additional for T1D population Known malignancy, active smoker (passive smoke exposure is not an criterium), relevant congenital defects
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 21.0-999.0, Nonalcoholic Steatohepatitis Adults, age 21 or above, with diagnosis of T2DM according to the American Diabetes Association (ADA) clinical practice recommendations T2DM is defined according to American Diabetes Association (ADA) clinical practice recommendations if one of the following is met Diabetes symptoms (polyuria, polydipsia, polyphagia, increased fatigue, weight loss, blurred vision) exist and casual plasma glucose ≥200 mg/dl (11.1 mmol/l) OR Fasting plasma glucose (FPG) ≥126 mg/dl (7.0 mmol/l); OR Plasma glucose ≥200 mg/dl (11.1 mmol/l) during a 75-g oral glucose tolerance test (OGTT) (25) If any of these test results occur, testing should be repeated on a different day to confirm the diagnosis. OR hemoglobin A1C (HbA1C) ≥6.5% (26) The subject is fully informed and willing and able to perform all the procedures specified in the protocol and signed a written informed consent to participate Documented history of cardiovascular disease (CVD), such as acute coronary syndrome (ST elevation myocardial infarction, non-ST elevation myocardial infarction, unstable angina), stable angina, history of angioplasty or stent placement, cerebrovascular disease (ischemic or hemorrhagic stroke), and peripheral vascular disease History of congestive heart failure Evidence of other causes of chronic liver disease Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg) Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab) Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 1.0-15.0, Gastroenteritis Diabetes Mellitus (Ketoacidosis) previously healthy children history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis) congenital heart diseases intestinal obstruction any signs of abdominal hypertension any illnesses known to affect the volume status
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Knee Osteoarthritis Both sexes Painful Knee Osteoarthritis with presence of osteophytes on radiography At least 1 of the following 3 criteria's: adult >50 years old, morning stiffness <30 minutes, or in the pre-stage surgical (programmed knee prosthesis replacement) Acceptance to participate in the study Patients affiliated to a social security scheme (beneficiary entitled) Patient under guardianship, or protection of justice Cognitive impairment Contraindications to Physical Activities Patient in the incapacity to answer the questionnaire
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-45.0, Healthy Volunteers An understanding, ability, and willingness to fully comply with study procedures and restrictions Ability to voluntarily provide written, signed, and dated informed consent and assent as applicable to participate in the study Aged 18 inclusive at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This criterion will only be assessed at the first screening visit Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a full physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, coagulation (as appropriate), serum chemistry, and urinalysis Body mass index (BMI) >= 18.0 and l<=32.0 kilogram per square meter (kg/m^2) at screening. Body weight for a participant in Cohort 1 will be >= 40.0 kg to <= 75.0 kg, and body weight for a participant in Cohort 2 will be > 75.0 kg to <= 120.0 kg, inclusive. This criterion will be assessed at the screening visit and confirmed at first check-in History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures Positive PCR (polymerase chain reaction) test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), either with the absence or presence of the clinical symptoms of Coronavirus disease 2019 (COVID-19) Known or suspected intolerance or hypersensitivity to teduglutide, closely-related compounds, or any of the stated ingredients Significant illness, as judged by the investigator, within 2 weeks of the first dose of teduglutide Known history of alcohol or other substance abuse within the last year prior to screening Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to receiving the first dose of teduglutide Pregnant or lactating female Within 30 days prior to the first dose of teduglutide: 1. Have used an investigational product (if elimination half-life is lesser than [<] 6 days, otherwise 5 half-lives) 2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's (or designee's) opinion, may impact this study 3. Have had any substantial changes in eating habits, as assessed by the investigator (or designee) Use of dipeptidyl peptidase 4 inhibitors within 30 days or 5 half-lives, whichever is greater, prior to administration of the first dose of teduglutide
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-80.0, End-Stage Renal Disease Type 2 Diabetes Aim 1a/b Ambulatory patients with type 2 diabetes 80 years of age willing to perform at least 4-8 self-monitored blood glucose (SMBG) tests at home HbA1c 5-12% eGFR < 15 mL/min/1.73m2 receiving dialysis (hemodialysis) for at least 3 months on insulin therapy [basal insulin alone (glargine U100, glargine U300, determir, degludec, NPH)], or in combination with bolus insulin (at least one or more injections of aspart, lispro, glulisine, regular insulin) or in combination with incretin therapy (sitagliptin, linagliptin). Aim 2a adult subjects with type 2 diabetes receiving hemodialysis at the Emory Dialysis Center or Grady Dialysis Unit (for at least 90 days) Aim 1a/b critical medical or surgical illness, active malignancy with ongoing therapy unable to give informed consent severe hypoglycemia (BG < 40 mg/dL) severe hyperglycemia (BG> 400 mg/dL) pregnancy or breastfeeding severe anemia (Hemoglobin < 5 mg/dl) polycythemia (Hemoglobin >17 mg/dl) subjects taking acetaminophen (more than 1 gr every six hours) hydroxyurea (may cause interference with the sensor membrane)
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Diabetes Mellitus, Type 2 Are male or female not of childbearing potential Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening Have had a stable body weight (<5% body weight change) for the 3 months prior to screening Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening Have an HbA1c of at least 7.0% and no more than 10.5% at screening Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator Have type 1 diabetes mellitus or latent autoimmune diabetes in adults Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea Have a history of acute or chronic pancreatitis Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 50.0-79.0, Hypertension Nutritional and Metabolic Diseases Cardiovascular Risk Factor Hypertensive patients that received only one type of medication Uncontrolled blood pressure: 140mmHg≤SBP≤149mmHg, 90mmHg≤DBP≤99mmHg Able to sign informed consent and come to follow-up session by themselves Type 1 or 2 diabetic patients, or taking anti-diabetic drugs Taking two types or above anti-hypertensive drugs Alanine transaminase or Aspartate Transaminase exceeding normal limits for 2 times or above Acute myocardial infarction, heart failure or stroke in the last 6 months Suffering from chronic gastrointestinal diseases Taking calcium or magnesium supplements in a regular basis (at least once per week) in the previous year In pregnancy or breastfeeding period, or planning to be pregnant Other serious diseases (e.g. cancer) that are not eligible for participation Participating in other studies
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 12.0-25.0, Type 1 Diabetes Age ≥12.0 and ≤25 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. Currently using insulin for at least six months 4. Currently using insulin pump for at least three months 5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 6. Access to internet and willingness to upload data during the study as needed 7. For females, not currently known to be pregnant or breastfeeding 8. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 9. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use 10. Willingness to use the UVa artificial pancreas system throughout study sessions. 11. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study 12. Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d 13. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals) 14. Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission 15. Willingness to reschedule Study Dinner Sessions if placed on oral steroids 16. An understanding and willingness to follow the protocol and signed informed consent History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 3. Pregnancy or intent to become pregnant during the trial 4. Currently being treated for a seizure disorder 5. Planned surgery during study duration 6. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) 7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 8. Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperglycemia Postoperative Complications Insulin Resistance All postoperative patients who will be admitted to surgical ICU and developed Post Surgical Hyperglycemia will be eligible for evaluation for and All patients having diabetes mellitus, history of preoperative stress hyperglycemia, endocrinopathies, obesity defined as body mass index (BMI) >30 kg/m2, age younger than 18 years, renal impairment or maintenance on renal replacement therapy and liver diseases
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetic Ketoacidosis Type 1 Diabetes Type 2 Diabetes Age ≥ 18 years old Meet DKA definition (BG ≥ 250 mg/dl, Anion Gap > 12 mEq/L, and positive Ketones in serum or urine) Having the capacity to sign Informed consent IV insulin infusion was initiated for more than 4 hours Persistent hypotension (SBP<80 mmHg despite receiving 1000cc normal saline) Require Vasopressor Acute Coronary Syndrome Pregnant End-stage renal disease Unwilling to consent to participate in the trial Currently under police custody Transferred from another hospital Require emergent surgery
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-55.0, Non-Alcoholic Fatty Liver Disease Patients posted for Upper GI endoscopy for other indications 2. 18 yrs of age with NAFLD and 3. BMI ≤ 35 or 4. Body Mass Index (BMI) is ≤30 to 34.9 kg/m2 with at least one treated or untreated comorbid condition (hypertension, dyslipidaemia, cardiovascular disease, glucose intolerance, sleep apnoea, NASH). 5. Ambulatory and able to perform the ILBS healthy lifestyle (diet and exercise program). 6. Failed to life style therapy HIV, HBsAg or HCV positive 2. Prior bariatric surgery 3. Change in weight of ≤5 % within 3 months 4. Malignancy within 5 years 5. Recent major surgery; history of seizure disorder 6. Depression or other major psychiatric disease within 2 years requiring treatment with prescription medication 7. Pregnancy or lactation 8. Significant uncontrolled cardiopulmonary diseases 9. Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening 10. Hypo or hyperthyroidism uncontrolled. If initiation or adjustment of doses of these drugs is anticipated, patients should not be enrolled. 11. Patients being treated for hypothyroidism must be adequately replaced on a stable dose of medication for at least 3 months prior to screening. 12. Uncontrolled DM with HbA1c greater than 9%. 13. Recent treatment (i.e., within 1 month of the screening visit) with weight drugs or products or appetite suppressants (including herbal weight agents) 14. Recent treatment (i.e., within 3 months of the screening visit) with oral or parenteral corticosteroids 15. Recent history (within 2 years prior to the screening visit) of significant alcohol use 16. Significant change in diet or level of physical activity within 1 month prior to enrolment 17. Use of very-low calorie (< 1,000/day) liquid weight diet within 6 months
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-75.0, Type 1 Diabetes Patients must meet ALL to be included in the study. 1. Patient age is 18-75 years. 2. Diagnosis of T1D of at least 1-year duration. 3. Has the ability to provide informed consent before any trial-related activities. 4. Treated with insulin glargine as their basal insulin in the 3 months preceding screening visit. 5. Stable insulin regimen (defined as change of <20% in the total daily dose of insulin and no change to the basal insulin agent) over the 3 months preceding the screening visit. 6. Patient willing to dose their basal insulin at bedtime. 7. Hemoglobin A1c < 9% in the 3 months preceding screening visit. 8. Able to self-administer their insulin doses. 9. Able to do self-monitoring of blood glucose using a glucose meter and willing to do this at least 2 times daily for patients using a CGM that requires calibration prior to the study and 4 times daily for patients who were not using a CGM prior to the study. 10. Agreeable to the use of a continuous glucose monitor (CGM) for the duration required in the study. If already using a CGM prior to the study, then agreeable to wearing the blinded study CGM concurrently during the study period. 11. Will be reachable by phone and/or email to comply with study procedures. 12. Will be able to comply with study procedures, per investigator's opinion. 13. Patient agrees to not use correctional insulin unless BG ≥250 for the 48 hours before and after 1st dose of IDeg Patient must not have ANY of the to be included in the study. 1. Patients with eGFR <30 on at least 2 measurements within 1-year of the screening visit. 2. History of myocardial infarction within 6 months preceding the screening visit. 3. Patients taking non-insulin medications for the glycemic management of T1D (including metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, pramlintide) 4. Known or suspected allergy to IDeg or one of its excipients. 5. Pregnant, planning to become pregnant in the next 3 months or breastfeeding. 6. Participation in a clinical trial with investigational drug within 1 month of the screening visit or at present. 7. Skin condition that prevents the insertion of the CGM. 8. Previously randomized and received drug in this study. 9. Presence of decompensated or poorly controlled psychiatric conditions. 10. Current known or suspected illicit substance use. 11. Any anticipated surgery or procedure in the next 14 days. 12. Patients using U-300 glargine as their basal insulin. 13. Patients using insulin afrezza as their short-acting insulin. 14. Use of glucocorticoid burst/pulse therapy within 14 days prior to screening visit (chronic stable glucocorticoid doses are acceptable)
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-100.0, Irreversible Pulpitis Patient in American Society of Anesthesiologists I or II condition Patient who comes to the emergency room with irreversible pulpitis in a single tooth Patients of age >20 years Positive response to the vitality test and bleeding after pulp exposure American Society of Anesthesiologists patients>II Pharmacological allergies that contraindicate the intervention Teeth with negative vitality test and no bleeding after pulp exposure Signs of concomitant periodontal infection such as swelling or fistula Teeth with immature roots Patients who are medicated with anxiolytics Abuse of psychotropic drugs or medication that may alter the perception of pain 15 days before the intervention Pregnant or breast-feeding women Interventions with conscious sedation Pathological mental state (dementia, psychosis)
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0
|
The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Recurrent Acute Myeloid Leukemia Documented informed consent of the participant and/or legally authorized representative Age: >= 18 years on the day of signing informed consent Eastern Cooperative Oncology Group (ECOG) =< 2 Patients with histologically confirmed acute myeloid leukemia (AML), according to World Health Organization (WHO) with relapsed disease after allogeneic hematopoietic cell transplantation (alloHCT) Patients with non-central nervous system (CNS) extramedullary disease may be included if they also have marrow disease Patients with acute promyelocytic leukemia (APL) will not be eligible Fully recovered from the acute toxic effects (except alopecia) to =< grade 1 of prior anti-cancer therapy Total bilirubin =< 2 x ULN (unless has Gilbert's disease) (to be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated in the study calendar) Aspartate aminotransferase (AST)=< 2 x ULN (to be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated in the study calendar) Alanine aminotransferase (ALT) =< 2 x ULN (to be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated in the study calendar) (to be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated in the study calendar)
|
0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
|
eligible ages (years): 18.0-60.0, Type 1 Diabetes Mellitus Diabetic Ketoacidosis Patients with type 1 diabetes Type 1 diabetes diagnosis C-peptide negative < BMI < 26 written consent Severe comorbidity Regular medication apart from insulin (except over-the-counter medicines) Use of long acting insulin analogues, that work > 24 hours, e.g. Tresiba PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other). Healthy control subjects < BMI < 26 written consent Chronic disease Regular medication (except over-the-counter medicines) PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 2.0-5.0, Type 1 Diabetes Mellitus With Hypoglycemia type1diabetes Toddlers and preschool children with T1D on insulin therapy patients with other medical conditions (i.e. celiac disease or autoimmune thyroiditis), patients with other types of diabetes mellitus (i.e. maturity onset diabetes of youth (MODY) and type 2 diabetes mellitus), patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes, renal impairment due to cause other than diabetes, hypertension, patients taking any vitamins or food supplements one month before study and participation in a previous investigational drug study within 3 months preceding screening
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1
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