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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): 10.0-25.0, Type 1 Diabetes Mellitus Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM) On insulin glargine for at least 3 months Age 10-25 years Not on medications that may affect glucose concentrations Hemoglobin A1C (HbA1C) of less than 9 % Body Mass Index (BMI) less than 95th % and more than 10th% Supportive family Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM) Unable to adhere to insulin regimen Positive urine pregnancy test
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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, Diabetes Mellitus, Type 2 Insulin Resistance Obesity Age: 18 to 60 years BMI between 25 and 29,9 kg/m² Weight variance less than 5% in the last 3 months Previous diagnosis of diabetes type 2 Insulin requirement, alone or along with oral agents Capacity to understand the procedures of the study To agree voluntarily to participate of the study, signing an informed consent Positive Anti-GAD antibodies Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL History of hepatic disease like cirrhosis or chronic active hepatitis Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men) Hepatic dysfunction: ALT and/or AST 3x above upper normal limit Recent history of neoplasia (< 5 years) Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three 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): 18.0-60.0, Diabetes Mellitus, Type 2 Age: 18 to 60 years BMI between 25 and 29,9 kg/m² Weight variance less than 5% in the last 3 months Previous diagnosis of diabetes type 2 Insulin requirement, alone or along with oral agents Capacity to understand the procedures of the study To agree voluntarily to participate of the study, signing an informed consent Positive Anti-GAD antibodies Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL History of hepatic disease like cirrhosis or chronic active hepatitis Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men) Hepatic dysfunction: ALT and/or AST 3x above upper normal limit Recent history of neoplasia (< 5 years) Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three 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): 21.0-60.0, Diabetes (young groups) Adults older than 21 years and less than 40 years Subjects must either have: Insulin sensitivity with a fasting blood glucose less than 100 mg/dl and a 2-hour post oral glucose tolerance test blood glucose less than 140 mg/dl or Insulin resistance as defined by a fasting blood sugar of greater than or equal to 100mg/dl but less than 125 mg/dl and/or a 2-hour post oral glucose tolerance test blood glucose greater than 140 mg/dl and less than 200 mg/dl. Subject understands protocol and provides written, informed consent. (middle age groups) Adults greater than or equal to 40 years and less than or equal to 60 years Subjects must either have: Insulin sensitivity with a fasting blood glucose less than 100 mg/dl and a 2-hour post oral glucose tolerance test blood glucose less than 140 mg/dl or Insulin resistance as defined by a fasting blood sugar of greater than or equal to 100mg/dl but less than 125 mg/dl and/or a 2-hour post oral glucose tolerance test blood glucose greater than 140 mg/dl and less than 200 mg/dl. or Type II diabetes as defined by a fasting blood sugar of greater than 125 mg/dl and/or a 2-hour post oral glucose tolerance test blood glucose greater than 200 mg/dl if untreated and/or if subjects are on oral hypoglycemic agent therapy where the HbA1c is greater than 6.7 percent. Subject understands protocol and provides written, informed consent (all study volunteers and subjects) Uncontrolled hypertension or therapy with a Beta-blocker History of heart failure (or ejection fraction less than 55 percent by echocardiogram), unstable coronary artery disease or symptomatic peripheral arterial disease requiring changes in medication or medical intervention in the preceding 3 months. Insulin-dependant diabetes mellitus or current use of thiazolidinediones Women of childbearing age unless recent pregnancy test is negative and you are not breast feeding. Serum creatinine greater than 2.5 mg/dl Liver transaminase levels greater than 2.5 times upper limit of normal History of cancer in the last 5 years Active inflammatory disease, or infection, or abnormal white blood cell differential Enrollment in any drug studies within the last 30 days BMI greater than 35 for the middle age group and greater than 30 for the younger subjects
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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): 18.0-55.0, Diabetes Mellitus, Type 1 Adult male/female, 18 to 55 years old Diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous insulin pump Willing and able to follow all study-related instructions provided by the site staff Willing to provide signed informed consent Pregnant or a nursing female Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease Have HIV or hepatitis, or have alcohol or drugs in your system at the screening visit Have a history of alcohol abuse or have an eating disorder Have been in another research study in the last month or have taken certain medications in the 1 week before study drug would be taken
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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): 19.0-70.0, Islets of Langerhans Transplantation Diabetes Mellitus, Type 1 Group 1: Diagnosis of Type-1 diabetes mellitus for more than 5 years with at least one of the following complications Metabolic lability/instability (two or more episodes of severe hypoglycemia) or two or more hospital visits for diabetic ketoacidosis during the previous year Progression of secondary complications of diabetes as determined by The Nebraska Medical Center/University of Nebraska Medical Center staff endocrinologists Group 2: Diagnosis of Type-1 diabetes with successful renal transplant on steroid-free, FK506/rapamycin-based immunosuppression Severe co-existing cardiac disease Active alcohol or substance abuse, including cigarette smoking Psychiatric disorder making the subject not a suitable candidate for transplantation History of medical non-compliance Active infection, including hepatitis C and B, HIV, and tuberculosis (or suspected tuberculosis) Any history of malignancy except squamous or basal cell skin cancer BMI >28 kg/meter-squared, or body weight >80kg at screening visit, or >85kg on the day of transplantation (due to the difficulty of obtaining a sufficiently large islet mass to adequately treat either large patients or those whose obesity elevates their insulin needs) Positive C-peptide response to intravenous glucose tolerance test and Mixed Meal glucose tolerance test: any C-peptide >0.3 ng/mL post infusion Inability to provide informed consent Age less than 19 or greater than 70 years
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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, Hyperglycemia Patients who are admitted to Medical or Surgical ICU History of diabetes mellitus Newly diagnosed hyperglycemia (defined as a blood glucose greater than 140 mg/dl on ≥ 2 occasions) Subjects must have an admission blood glucose < 500 mg/dL, without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones) Non-Diabetic patients Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state Patients with known HIV Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl) Patients with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study Female subjects who are pregnant or breast feeding at time of enrollment into 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, Diabetes Mellitus Diabetes Complications Ages 18 years or older Undergoing elective total knee, hip or lumbar spinal surgery Pregnancy Unable to give 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): 18.0-80.0, Diabetic Ketoacidosis All patients admitted to Grady Memorial Hospital who meet diagnosis of DKA and who are willing to participate in the study protocol will be considered candidates for into the study Diagnostic for DKA: Blood glucose > 250 mg/dL, arterial or venous phenol hydroxylase (pH) < 7.3, serum bicarbonate < 18 milliequivalent/L, and moderate to severe ketonemia (acetoacetate ≥ 1:4 or βeta-hydroxybutyrate > 3 mmol) Hemodynamic instability (MAP < 50 or patients requiring pressor) Significant identifiable medical or surgical illness, including but not limited to: acute myocardial infarction, congestive heart failure; respiratory failure requiring mechanical ventilation; acute or chronic renal insufficiency (serum creatinine > 3.0 mg/dl); end stage liver failure, and cirrhosis Patients with dementia or persistent altered mental status that would prevent collection of consent form and reliable information Pregnancy
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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, Type 2 Diabetes Males or females between the ages of 18 and 70 years admitted to a general medical service. 2. A known history of type 2 diabetes mellitus > 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy. 3. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, positive serum or urinary ketones) Subjects with increased blood glucose concentration, but without a known history of diabetes. 2. Subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [63]. 3. Patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization course. 4. Patients with clinically relevant hepatic disease (ALT 2.5x > upper limit of normal), or impaired renal function, as shown by a serum creatinine ≥2.0 mg/dL for males, or ≥ 1.8 mg/dL for females. 5. History of drug or alcohol abuse within the last 2 years. 6. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 7. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism. 8. Female subjects are pregnant or breast feeding at time of enrollment into 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): 18.0-80.0, Type 2 Diabetes Mellitus Age 18-80 years 2. History of type 2 diabetes mellitus for at least 3 months 3. Prior therapy with dietary management, oral agents, or insulin 4. Non child-bearing potential or a negative urine pregnancy test 5. Initial blood glucose in ER > 200 mg/dl Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation. 2. Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention. 3. History of current drug or alcohol abuse. 4. History of current mental illness 5. Inability to give informed consent 6. Female patients who are pregnant or are breast feeding 7. Patients who have clinically significant liver disease with ALT/AST > 3 times the upper range of normal 8. Patients currently treated with dialysis
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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 2 Diabetes Inpatient Hyperglycemia Males or females between the ages of 18 and 80 years admitted to a general surgery service. 2. Patients admitted for non-cardiac elective or emergency surgery or trauma. 3. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones). 4. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones) Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia). 2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria. 3. Acute critical illness or CABG surgery expected to require prolonged admission to a critical care unit (ICU, CCU, SICU, Neuro ICU). 4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl. 5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 6. Female subjects are pregnant or breast feeding at time of enrollment into 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): 18.0-75.0, Diabetes Mellitus, Type 1 Type 1 diabetic subjects Treated with insulin for at least 2 years and by CSII for at least 6 months Using the same insulin (insulin glulisine, insulin aspart or insulin lispro) in CSII for at least 3 months with the same external pump compatible with the 3 short acting insulin analogues used in the study Using the same type of infusion set (catheter and cannula) for at least 3 months Performing at least 3 blood glucose controls per day HbA1c < 8.5% Body mass index (BMI) < 35 kg/m² Ability and willingness to perform blood glucose and ketone monitoring using the Sponsor-provided combined glucose and ketone meter and patient diary at home Diabetes other than Type 1 Total daily dose of insulin greater than 90 U/day Using an insulin pump requiring pre-filled cartridges History of infection at infusion site requiring a drainage in the last 3 months History of severe episodes of ketosis requiring hospitalization in the last 6 months Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study. An ophthalmoscopic examination should have been performed in the 2 years prior to study entry Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) or breastfeeding Treatment with systemic corticosteroids or medication known to influence insulin sensitivity in the 3 months prior to visit 1 Treatment with antidiabetic drug other than insulin in the 3 months prior to visit 1 Likelihood of requiring treatments during the study which are not permitted
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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, Type 1 Diabetes Type 1 diabetic patients Diabetes duration =/> 1 year HbA1c ~ 7,5% Recent onset of DM BMI < 18 OR > 35 kg/m2 T2DM History of major heart/renal disease Severe untreated proliferative retinopathy History of recurrent severe hypoglycaemia (History of) brain disorders Alcohol abuse,(History of) drug abuse, benzodiazepines, selective beta-blockers, oral steroids, oral anticoagulants Current psychiatric disease/treatment (history of) eating disorders
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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 2 Diabetes Hypertension Males or females aged 18 to 80 years Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide); Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association including the specific plasma glucose results listed below Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to polyuria, polydipsia, and unexplained weight loss; or Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP >130 mmHg and/or DBP >80 mmHg) on current antihypertensive monotherapy or combination therapy Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria Females should not be pregnant or lactating and, if applicable, using adequate contraception Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator) Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at screening Subjects with type 1 or type 2 diabetes mellitus requiring insulin Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension
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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, Diabetes Subjects meeting all of the following will be considered for enrollment into the study Males or females between the ages of 18 and 80 years admitted to a general medical service A known history of type 2 diabetes mellitus > 3 months, receiving diet management, any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, positive serum or urinary ketones) Subjects with increased blood glucose concentration, but without a known history of diabetes Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation Patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization course History of current drug or alcohol abuse Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study Inability to give informed consent Female patients who are pregnant or are breast feeding Patients who have clinically significant liver disease with ALT/AST > 3 X the upper range of normal Patients with serum creatinine ≥3.5 mg/dL for males or ≥ 3.0 mg/dL for females or currently treated with dialysis
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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 Type 2 All laboratory measurements are to be performed after an overnight fast ≥ 10 hours in duration. Patients with laboratory screening values/findings not meeting protocol may, at the discretion of the investigator, have one repeat determination performed. If the repeat value satisfies the criterion they may continue in the screening process. Only the laboratory test not meeting should be repeated (not the entire panel) Glucose Metabolism and Therapy Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. Patients Requiring Specific Treatments Patient has symptomatic hyperglycemia requiring immediate initiation of insulin therapy Patient has a history of intolerance or hypersensitivity to metformin or sitagliptin or has any contraindication to use metformin. Concomitant Disease of Organs and Systems Patient has a medical history of active liver disease (excluding hepatic steatosis) Patient has severe active peripheral vascular disease (e.g., manifested by claudication with minimal activity, a non-healing ischemic ulcer, or disease which is likely to require intervention such as with bypass or angioplasty) Patient has unstable or acute congestive heart failure Patient has a history of malignancy without documentation of remission/cure. Other Patient is pregnant, has a positive urine pregnancy test at Visit 1, is expecting to conceive within the projected duration of the study, or is breast feeding Based on Lab Abnormalities
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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): 18.0-60.0, Obesity Diet Therapy Weight Loss Weight Gain Nutrition Therapy BMI greater than or equal to 27 kg/m(2) for the weight loss protocol but body weight less than 350 pounds to accommodate the DXA scanner BMI less than or equal to 24 kg/m(2) (and BMI greater than or equal to 18.5 kg/m(2) for the overfeeding protocols. A history of low BMI and difficulty gaining weight Age 18-60 years, to minimize potential co-morbid conditions which may indirectly affect EE. Minors under the age of 18 will be excluded because growth and pubertal issues are significant parameters that could affect our outcomes and also because the time requirements of the study are such that they would interfere with school schedules. Women who are post-menopausal will be excluded from the study as changes in their metabolism could affect the baseline measurements which are hypothesized to predict weight change Healthy, as determined by medical history, physical examination, and laboratory tests Current smoking Type 2 diabetes (according to the World Health Organization diagnostic criteria) Impaired glucose tolerance (according to the World Health Organization diagnostic criteria) for those participating in the overfeeding study arms only Endocrine disorders (Cushing s Disease, pituitary disorders, and hypo and hyperthyroidism) Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for one week before study entry) Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease) Hypertension (blood pressure measurement higher than 140/90 mm Hg (overfeeding study) or 160/95 (weight loss study) on two or more occasions or use of anti-hypertensive medications) Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g., Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g., celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study Presence of a pacemaker or other implantable devices/shrapnel which may interfere with the MRI or CorTemp measurements
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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 Dawn Phenomenon Written informed consent obtained prior to performing screening evaluations Male or female, 18 yrs or older Diagnosis of type 1 diabetes made 5 years prior to screening visit A1C > 6.0% and 9.0% at screening visit Body Mass Index (BMI) 35 kg/m2 at screening visit Documented undetectable C-Peptide Ability to follow instructions for Continuous Glucose Monitoring System (CGMS) Multiple daily injection participants on at least 3 injections per day. May be treated with NPH or glargine Pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception. Females of childbearing potential must have a negative pregnancy test at Visit 3 and Visit 5. Females who become pregnant during the study will be discontinued Type 2 diabetes Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening Drugs known to affect glycemia (eg. steroids, beta blockers) or conditions that are likely to require steroid therapy or cause metabolic instability in the next 6 months History of allergy or intolerance to NPH or glargine History of hypoglycemia unawareness i.e. no warning symptoms accompanying low (<50 mg/dl) blood glucose levels Unable and/or unlikely to comprehend and/or follow the study protocol (including self blood glucose monitoring, CGMS) Currently using an insulin pump Pituitary disorder (Acromegaly, Cushing's, Hypothyroidism etc.) or tumor Two or more severe hypoglycemic episodes (requiring assistance) within six months of 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): 18.0-75.0, Type 2 Diabetes Individuals more than 18 years of age with DM2, either with new onset DM2 or known diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting with fasting blood glucose (FBG) 300-500 mg/dl or random blood glucose (RBG) 400-700 mg/dl and who did not have any listed in Table 1, were eligible for the study Acute metabolic complications (diabetic ketoacidosis, hyperosmolar hyperglycemia associated with dehydration) Acute complications of chronic cardiovascular, neurological, renal, and other diabetic complications Any subject with unstable vitals signs (temperature > 101 degrees F, systolic blood pressure < 90 or > 180 mm hg, diastolic blood pressure < 60 or > 110 mm hg, heart rate < 60 or > 120 beats/minute) Electrolyte imbalances (serum bicarbonate level < 20 mEq/L, serum sodium < 125 & > 150 mEq/L, serum potassium < 3.5 & > 5.5 mEq/L) Evidence of an impaired sensorium and/or dementia Age > 75 years Subjects with any acute medical illness Type 1 diabetes or type 2 diabetics weighing less than 120 lbs Current addiction to illicit substances or alcohol abuse
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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, Diabetic Macular Edema years of age at least Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present current regular use of insulin for the treatment of diabetes current regular use of oral hypoglycemic agents for the treatment of diabetes diabetes as defined by american Diabetes Association (ADA) symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eighth-hour fasting plasma glucose > 126 mg/dl Diabetic macular edema clinically observable associated with diabetic retinopathy without prior foveal treatment with laser therapy if photocoagulation or peripherical or macular laser, at least 3 months absence of macular ischemia by fluorescein angiography on baseline visit Uncontrolled systemic disease Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit Any ocular condition in the study eye that in the opinion of the investigator would prevent a 2 lines improvement of visual acuity (e.g. severe macular ischemia) Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema Presence of an epiretinal membrane in the study eye History of IOP elevation in response to steroid treatment in either eye History of glaucoma or optic nerve head change consistent with glaucoma damage Ocular hypertension requiring more than 1 anti-glaucoma medication to maintain IOP < 11mmhg at qualification visit Presence of anterior chamber intraocular lens in the study eye
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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 2 Obese African American subjects (body mass index (BMI) equal or greater than 30) Age 18-65 Patients with a history of diabetic ketoacidosis as defined by the American Diabetes Association (ADA) Patients admitted with hyperglycemia but without ketoacidosis (blood glucose greater than 400ml/dl without evidence of ketosis/ketones Obese nondiabetic controls (BMI >30; ruled out for diabetes with a 75g oral glucose tolerance test) Patients with positive autoimmune markers (islet cell or glutamic acid decarboxylase (GAD) autoantibodies) Patients with significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism Patients with bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies Patients with fasting hyperglycemia (blood glucose > 120 mg/dl) after discontinuation of insulin therapy Pregnancy
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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 Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Informed consent obtained before any trial-related activities Subjects diagnosed with type 1 or type 2 diabetes. If type 2 diabetics, treatment with or without oral anti diabetic medication is allowed Current users of vial/syringe (pen naïve) treated with short-acting insulin (insulin aspart, glulisine or lispro) and once daily long-acting insulin (detemir or glargine) or once daily long-acting insulin (detemir or glargine) alone Treatment with insulin (i.e. aspart, glulisine, lispro, detemir or glargine) for at least 6 months Body Mass Index (BMI) less than 45.0 kg/m^2 HbA1c less than or equal to 9.0% at screening visit based on analysis from central laboratory Able and willing to adhere to the trial-specific insulin regimen for the entire trial period Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or inadequate contraceptive techniques during the trial period (adequate contraceptive measures are considered as intrauterine device, oral contraceptives and barrier methods) Previous participation in this trial (screening visit) Systemic drugs that may influence glycaemic control (e.g., corticosteroids) Known or suspected allergy to trial product(s) or related products Known or suspected abuse of alcohol or drug abuse Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Previous treatment with sitagliptin Clinically significant, active (or over the past 12 months) disease of the gastrointestinal, neurological, genitourinary, or haematological systems Cardiac disease defined as: Decompensated heart failure (New York Heart class III or IV, unstable angina pectoris within the past 6 months of study enrolment, myocardial infarction within the past 12 months and a clinically significant history of arrhythmias or conduction delays on electrocardiogram (ECG) over the past 12 months Any other severe acute or chronic illness as judged by the Investigator
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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, Diabetic Macular Edema years of age at least Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present current regular use of insulin for the treatment of diabetes current regular use of oral hypoglycemic agents for the treatment of diabetes diabetes as defined by american Diabetes Association (ADA) symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eigth-hour fasting plasma glucose > 126 mg/dl Diabetic macular edema clinically observable associated with diabetic retinopathy prior treated with any treatment or one or three sessions focal laser or grid for DME, intervals between sessions must be at least 30 days the most recent laser at least 3 months prior to Baseline, or no prior medical therapy for diabetic macular edema, or in the investigator opinion the patient would not benefit from macular laser treatment, or the patient refuses laser treatments BCVA score between 34 letters (20/320 ETDRS)e 68 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit Retinal thickness > 250 um by OCT Uncontrolled systemic disease Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15 letters improvement of visual acuity (e.g. severe macular ischemia) Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema Presence of an epiretinal membrane in the study eye History of IOP elevation in response to steroid treatment in either eye History of glaucoma or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye Ocular hypertension in the study eye requiring more than 1 anti-glaucoma medication to maintain IOP < 22mmHg at qualification visit Presence of anterior chamber intraocular lens in the study eye
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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, Obesity Type 2 Diabetes Mellitus Clinical diagnosis of T2DM diabetes mellitus with HbA1c ≤ 10.0% Current regular use of insulin Current regular use of oral hypoglycemic medication Documented diabetes by current ADA (98) Body mass index ≥ 35 kg/m2 in accord with the 1991 NIH obesity surgery consensus conference and stable weight for the previous 3 months Age between 18-60 years old Ability and willingness to provide informed consent No expectation that subject will be moving out of the area of the clinical center during the next 12 months Presence of CVD defined as: CAD, electrocardiographic for past myocardial infarction(s), ischemic stroke, peripheral artery bypass surgery, percutaneous transluminal angioplasty, or amputation because of atherosclerotic disease Significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy) Significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery Pregnancy or planning pregnancy Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl) Uncontrolled hypertension Smoking
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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 Type 1 diabetic participants, History of insulin dependance for at least one year, A1C 7%-9%, normal CBC, Chemistry Profile,be sufficiently stable pregnant women, children, prisoners, mentally ill individuals, patients currently utilizing continuous glucose monitors
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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 Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months). 2. Subject is between 18 and 75 years of age, inclusive. 3. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. 4. If female is of childbearing potential, is practicing a method of birth control. 5. Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2. 6. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit Subject uses exogenous insulin for glucose control. 2. Subject states that he/she has type 1 diabetes. 3. Subject states that he/she has a history of diabetic ketoacidosis. 4. Subject takes an alpha-glucosidase inhibitor. 5. Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. 6. Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix). 7. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. 8. Subject states that he/she has end stage organ failure or is status post organ transplant. 9. Subject states that he/she has a history of renal disease. 10. Subject states that he/she has current hepatic disease. 11. Subject states that he/she has a history of severe gastroparesis. 12. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 13. Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose. 14. Subject states that he/she has clotting or bleeding disorders. 15. Subject is known to be allergic or intolerant to any ingredient found in the study products
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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, Diabetes Diabetes Mellitus, Type 2 Type 2 diabetes mellitus for 12 months or longer Body Mass Index (BMI): 25.0-40.0 kg/m2, both inclusive HbA1c between 7.0 and 10.5% at screening Insulin treatment for at least 3 months prior to screening with a total daily dose of 0.6 and 0.9 U/kg body weight Use of any oral antidiabetic agent within the past 2 months Cardiac disease: NYHA class III or IV chronic heart failure (CHF), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening Hepatic insufficiency (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or greater than 2 times the central laboratory's upper reference limit) Renal insufficiency (serum creatinine equal to or greater than 1.6 mg/dL for males; equal to or greater than 1.4 mg/dL for females) Recurrent hypoglycaemia Anaemia (haemoglobin less than 13.0 mg/dL in males and less than 12.0 mg/dL in females; WHO-criteria) Use of concomitant medications (prescribed or non-prescribed and other than insulin) which may alter glucose metabolism including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
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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, Scar Prevention Scar Reduction keloid scar between 1 and 3 cm long, less than 1 cm at its widest point willing to undergo keloid scar removal surgery healthy adult male or non-pregnant female non-diabetic Body Mass Index in the range of 18-35 no clinically significant abnormal values on a full blood safety screen non-smoker and non-nicotine user for the previous six months history or clinical evidence of acute or chronic disease history of malignant neoplasm within the last 5 years, except for surgically removed cancers of the skin that are not on the keloid area history of anaphylactic shock or anaphylactoid (hypersensitivity) reaction allergy to local anesthesia, including lidocaine and epinephrine ongoing dermatologic disorders, except for folliculitis and acne on therapy with steroids on therapy with a drug that would affect collagen synthesis positive urine test for nicotine or drugs of abuse positive blood test for HIV 1 or 2, hepatitis B or hepatitis C positive blood test for anti-AZX100 antibodies
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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, Non Insulin Dependent Diabetes Pregnancy Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria Less than 24 weeks at study enrollment Singleton or twin pregnancy English or Spanish speaking Able to give informed consent End organ complications of diabetes (retinopathy, renal insufficiency, etc.) Prior need for insulin for glycemic control History of diabetic ketoacidosis (DKA) or hyperosmolar state Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin Kidney or liver disease Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded
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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, Diabetes Mellitus, Type 2 Uncontrolled blood sugar Random blood sugar ≥ 200mg/dl Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward Patient is able to eat and oral feeding is expected Patients receiving inpatient oral hypoglycemic agents Patients with chronic kidney disease stages 4 & 5 (estimated GFR of <30ml/min) and on dialysis Patient with chronic liver disease Patient with hypoglycemia unawareness Pregnancy Patients who are on "NPO" for medical reasons Patient is expected to stay in the hospital for less than 3 days Patient on a new inpatient insulin regimen for > 36 hours
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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, Scar Prevention Scar Reduction Keloid scar located below the neck between 1 and 3 cm long and less than 1 cm at its widest point Willing to undergo keloid scar excision surgery Healthy adult male or non-pregnant female Non-diabetic Body Mass Index in the range of 18-35 No clinically significant abnormal values on a full blood safety screen Non-smoker and non-nicotine user for the previous six months History or clinical evidence of acute or chronic disease History of cancer within the last 5 years, except for surgically removed cancers of the skin that are not near the keloid area History of anaphylactic shock or anaphylactoid (hypersensitivity) reaction Allergy to local anesthesia, including lidocaine and epinephrine Dermatologic disorders, except for folliculitis and acne On therapy with steroids On therapy with a drug that would affect collagen synthesis Positive urine test for nicotine or drugs of abuse Positive blood test for HIV 1 or 2, hepatitis B or hepatitis C Positive blood test for anti-AZX100 antibodies
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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 Renal Insufficiency Type 2 Diabetes Mellitus of mor than 1year GFR less than 30 ml/min/1.73m2 or dialysis Age greater than 18years Entry blood glucose (fasting or random) greater than 180mg% Type 1 Diabetes Mellitus New onset hyperglycemia Pregnant Solid organ transplant within 1 year Steroids prednisone greater than 7.5mg/day or equivalent Hospital LOS predicted less than 2 days Severe liver disease Known hypopituitarism or adrenal insufficiency Patients in the ICU Patients with hypoglycemic unawareness
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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): 4.0-11.0, Type 1 Diabetes Mellitus current patient in the Helen DeVos Children's Hospital Diabetes Clinic ages 4-11 years prepubertal (Tanner Stage I) diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis at least six months from date of diagnosis of type 1 diabetes mellitus TSH within reference range and negative transglutaminase IgA antibodies within nine months of study start HbA1C between 6.9 and 10% within 30 days of study start; parent or guardian able and willing to provide written informed consent prior to enrollment at time of study start, current insulin regimen includes multiple daily injections with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the pre-meal rapid acting insulin pubertal (Tanner stage 2 or greater) concurrent Addison's disease, celiac disease or untreated hypothyroidism receiving oral, injectable or inhaled steroids or immunosuppressant medications receiving stimulants for treatment of attention deficit disorder or attention deficit hyperactivity disorder intercurrent illnesses such as a fever > 101 degrees F, infection, or gastroenteritis use of any medication to treat diabetes other than those listed under in criteria potential for lack of compliance or any other issue which, in the opinion of the investigator, would compromise the subject's safety or successful participation 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): 18.0-999.0, Diabetic Ketoacidosis age 18 or older venous pH < 7.3 or arterial < 7.35 at least 2 of the following 3: 1. serum HCO3 < 18/anion gap > 16 2. serum glucose > 300 mg/dl 3. serum acetone positive pregnant less than age 18
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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): 7.0-20.0, Diabetes Type 1 Type 1 diabetes diagnosed less than 12 months prior to study entry 2. Age: 7-20 years old. 3. HbA1c>/=8.0 4. Signing inform consent form Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study. 2. Patients participating in other device or drug studies. 3. Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC. 4. Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire
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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 Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea No pre-treatment with any insulin in the last 3 months before the study Glycated Haemoglobin A1c (HbA1c) value between > or = 7.0 and > or = 9.5% Fasting Blood Glucose (FBG) > or = 120 mg/dl (6.7 mmol/l) Body mass index < 40 kg/m Ability to read and understand German language Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis Women of childbearing potential who will take adequate contraceptive protection Patients with type 1 diabetes mellitus Any history of ketoacidosis Pregnancy Prior treatment with insulin Treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, GLP-1 receptor agonists or with Dipeptidyl-Peptidase IV (DPP-IV) inhibitors History of drug or alcohol abuse Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry Following pancreatectomy Impaired hepatic function Impaired renal function
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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 Mellitus Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start Have an HbA1C > 7.0% and ≤ 10.0% Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2 Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications) Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Have previously completed or been withdrawn from this study after enrollment
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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, Type 2 Diabetes Mellitus Males and females (non-childbearing potential), aged 18-65 years Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout Body mass index < 42 kg/m^2 HbA1c value of 7 to 11% C-peptide ≥ 1.0 ng/mL Ability to provide written informed consent History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia Use of any blood glucose lowering agent other than metformin Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator Positive test result for glutamic acid decarboxylase (GAD) antibody Surgery within 6 months of screening Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1 Hypersensitivity to an SGLT2 inhibitor History of drug or alcohol abuse within the last 12 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): 18.0-60.0, Type 1 Diabetes type 1 diabetes severe hypo or hyperglycemia during last 6 months acute illness
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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): 18.0-38.0, Infertility HIV Infections Couple must attest to safe sex practices know the HIV-status of their partner be informed of risks of this procedure and alternatives, including donor insemination have the ability to provide informed consent been referred or self-refer to Dr. Schust for infertility treatment Female must be 18-38 years of age have a normal menstrual cycle before the IUI cycle be negative for HIV, gonorrhea, chlamydia, syphilis, hepatitis B and hepatitis C have a standard infertility evaluation and be a candidate for intrauterine insemination Male must
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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 Diabetes Mellitus, Type 1 FOR THE MAIN TRIAL, NN5401-3594 Type 1 diabetes mellitus for at least 12 months Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months HbA1c 7.0-10.0% (both inclusive) BMI (Body Mass Index) below or equal to 35.0 kg/m^2 FOR THE TRIAL, NN5401-3645 The subject must have completed the six-month treatment period in trial NN5401-3594 FOR THE MAIN TRIAL, NN5401-3594 Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months Cardiovascular disease within the last 6 months Uncontrolled treated/untreated severe hypertension Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements Cancer and medical history of cancer FOR THE TRIAL, NN5401-3645 Anticipated significant lifestyle changes during the trial Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
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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 2 Diabetes Hyperglycemia Males or females between the ages of 18 and 75 years admitted to a general medicine or surgical services A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (sulfonylureas, meglitinides, metformin, thiazolidinediones, dipeptidyl peptidase (DPP) IV inhibitors) Patients admitted for non-cardiac elective or emergency surgery or trauma Subjects must have an admission BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalent /L, potential hydrogen (pH) < 7.30, or positive serum or urinary ketones) Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia) Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [32] Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU Patients admitted for coronary artery bypass graft (CABG) or patients receiving continuous insulin infusion Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.0 mg/dl) Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study Female subjects are pregnant or breast feeding at time of enrollment into the study Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism Female subjects are pregnant or breast feeding at time of enrollment into 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 Diabetes Mellitus, Type 1 Type 1 diabetes mellitus for at least 12 months Current treatment with any basal bolus insulin for at least 12 months HbA1c below or equal to 10.0% BMI (Body Mass Index) below or equal to 35.0 kg/m^2 For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228) Use of any other antidiabetic drug than insulin within the last 3 months Cardiovascular disease within the last 6 months Uncontrolled treated/untreated severe hypertension Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements Cancer and medical history of cancer
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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): 1.0-999.0, Type 1 Diabetes Children Must have a diagnosis of T1D and have stored umbilical cord blood (10 patients sought) at the cord bank Vita 34 TID diagnosis will be defined as having a clear history of polydipsia, polyphagia, polyuria, and weight loss consistent with a clinical diagnosis, diagnosis will mot be based solely upon the presence of autoantibodies Cord blood meets all selection and testing (see below) Normal screening values for CBC, Renal function and electrolytes (BMP) Willing to comply with intensive diabetes management Not younger than 1 year of age Have complicating medical issues that would interfere with blood drawing or monitoring Require chronic use of steroids or other immunosuppressive agents for other conditions Cord Blood with viability < 50% Positive infectious disease markers from mothers blood or cord at time of collection (See below for details) Any evidence of illness on planned infusion date (i.e. fever >38.5 C, vomiting, diarrhea, wheezing, or crackles)
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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 2 Diabetes To participate patients must: 1. Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent. 2. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period. 3. Age range of 18 to 70 years (inclusive). 4. Patients must have been on a stable dose of allowed chronic medications for two months prior to entering the double-blind treatment period. 5. All participants must have the following laboratory values Hemoglobin ≥ 12 g/dl in males or ≥ 11 g/dl in females Serum creatinine ≤ 1.5 mg/dl AST (SGOT) ≤ 2.5 times upper limit of normal ALT (SGPT) ≤ 2.5 times upper limit of normal Alkaline phosphatase ≤ 2.5 times upper limit of normal Patients will be excluded if any of the following are present: 1. Individuals with type 1 diabetes or type 2 diabetes and a FPG ≥ 300 mg/dl. 2. Subjects on sulfonylureas, metformin and/or TZDs unless the dose has been stable for at least 2 months prior to study entry. 3. Patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. Patients taking systemic glucocorticoids will be excluded. 4. Past (within 1 year) or current history of alcohol abuse. 5. Patients will be excluded if there is a history of clinically significant heart disease (New York Heart Classification greater than grade II), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl)
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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, Alopecia Areata Subjects over the age of 18 2. Men and women 3. The presence of at least two lesions (centers) in diameter of at least 1.5 cm on both sides of the scalp. 4. Healthy with no diseases that constitute the background against the total label use steroids Pregnant women 2. Involvement of more then 50% of the scalp 3. Patients with immunodeficiency-related diseases 4. Patients receiving systemic steroids
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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 Patient affiliated to Social Security Written consent to participate to the study Ambulatory medical follow-up Patient with type 1 diabetes, defined by the of the American Diabetes Association in 1997, stable (no ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month) Underage patient, major patient under guardianship or protected by the Law Pregnant, parturient or breastfeeding woman Person with no freedom (prisoner), person hospitalized without consent and not protected by the Law Non-stabilized diabetes with at least one ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month Bedridden person or person with mobility impairment Patient already hospitalized at enrolment time Patient whose physical or psychological health could interfere with obtention of informed consent and compliance to the protocol (especially answers to the questionnaires) Terminally-ill patient
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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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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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): 18.0-85.0, Diabetes Mellitus The researchers will up to 300 patients both male and female between the ages of 18 and 85 diagnosed with type 1 or type 2 diabetes mellitus Self reporting or diagnosed with significant complications resulting from diabetes Taking oral agents and/or insulin for diabetic control Under an Endocrinologists supervision for their diabetes management Endocrinologist must assess and approve patient for participation in this study Ability to swallow without difficulty Ability to commit to the weekly time requirements associated with the study Other causes of complications not related to diabetes Lack of intravenous access Pregnancy Alcohol abuse, drug addiction or the use of illegal drugs Positive HIV Inability to breathe into machine for respiratory quotients
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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): 20.0-90.0, Hypoglycemia Up to 400 patients both male and female between the ages of 20 and 90 diagnosed with type 1 or type 2 diabetes mellitus All patients were diagnosed by their endocrinologists as having hypoglycemic unawareness, inability to sense low blood sugars All patients had failed conventional treatment for hypoglycemic unawareness All patients are taking oral agents and/or insulin for diabetic control All patients are under an endocrinologist's supervision for their diabetes management Endocrinologist must assess and approve patient for participation in this study All patients must demonstrate the ability to swallow without difficulty and the ability to commit to the weekly time requirements associated with the study Other causes of complications not related to diabetes Lack of intravenous access Pregnancy Alcohol abuse, drug addiction or the use of illegal drugs HIV positive Inability to breathe into machine for respiratory quotients
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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, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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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 Mellitus Age > 18 years Type 2 Diabetes Mellitus random BG > 200 mg/dL willing and able to provide informed consent and to participate in diabetes self-management education (DSME) stable for discharge from the ED once hyperglycemia treatment initiated type 1 Diabetes Mellitus diabetic ketoacidosis or hyperosmolar non-ketotic state concomitant treatment with glucocorticoids (other than stable maintenance dose therapy) cognitive or physical impairment preventing participation in DSME unwillingness or inability to provide consent and/or attend follow-up visits
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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, Blood Glucose Coronary Artery Bypass Insulin Coronary Disease All diabetic patients going for isolated, non-emergent CABG surgery at Inova Fairfax Hospital (IFH). 2. Non diabetic patients going for isolated, non-emergent CABG Surgery at IFH that are found to have a finger stick blood glucose > 150 mg/dl, either pre-operative, during the procedure or post-operatively. 3. Those patients that meet #1 OR #2 AND have been started on an insulin infusion while in the operative room will be enrolled Patients that are not undergoing CABG surgery. 2. Patients that post-CABG surgery are not on an insulin infusion. 3. Patients that are undergoing other procedures in addition to CABG will be excluded. (ie. CABG + valve repair)
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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, Acne Vulgaris Allergic Rhinitis Anxiety Asthma Back Pain Prostatic Hyperplasia Bursitis Chronic Obstructive Pulmonary Disease Cough Coronary Artery Disease Depression Diabetes Mellitus Diarrhea Gastroesophageal Reflux Fibromyalgia Headache HIV Infections Hypothyroidism Hyperlipidemia Hypertension Influenza Sleep Initiation and Maintenance Disorders Irritable Bowel Syndrome Migraine Disorders Obesity Obstructive Sleep Apnea Osteoarthritis Senile Osteoporosis Shoulder Pain Sinusitis Smoking Cessation Tobacco Use Cessation Menopause Urinary Incontinence Urinary Tract Infection Vaginitis Vertigo one of the 40 target health conditions absence of at least one of the target 40 conditions
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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, Diabetes 21 years old or older 2. MI documented by increase in troponin > 0.78 ng/ml or CKMB ≥ 3% of total CK Patients who have Type-2 diabetes defined by any one of the following: 3. Confirmed (i.e., two or more readings) fasting blood glucose >126mg/dl; or 4. Random glucose ≥200mg/dl; or 5. 2 hour glucose ≥200mg/dl following 75g of glucose; or 6. Current treatment with diet or oral agents directed at the control of hyperglycemia either alone or in combination with insulin; or 7. Current treatment with insulin with no prior history of diabetic ketoacidosis Type-1 diabetes. 2. Class III or IV heart failure. 3. Cardiomyopathy (including hypertrophic and amyloidosis). 4. Congenital or pericardial diseases. 5. Intolerance to either ACE inhibitor, AT1-RB or allopurinol. 6. Renal failure with creatinine > 2.5 mg/dl. 7. Renal artery stenosis. 8. Severe comorbidity such as liver disease or malignancy. 9. Pregnancy (negative pregnancy test and effective contraceptive methods are required prior to enrollment of females of childbearing potential (not post-menopausal or surgically sterilized). 10. Chronic steroid use. 11. Unable to understand or cooperate with protocol requirements. 12. Severe claustrophobia. 13. Presence of a pacemaker or non-removable hearing aid. 14. Presence of metal clips in the body
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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 men or women aged 20-70 years with type 2 diabetes lasting more than one year who had used the online communication system for diabetes management at the web site https://www.bi odang.com for more than six months baseline HbA1c level was 6-10% Patients who able and willing to complete glucose-monitoring diaries on a web chart as instructed patients who required intensive insulin therapy (multiple insulin injections or insulin pump therapy) or who were unwilling to use self-monitoring of blood glucose (SMBG) acute metabolic complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar non-ketotic hyperglycaemia, lactic acidosis) serum creatinine concentration >2.0 mg/dl at screening active liver disease or ALT or AST activities >2.5 times the upper limit of normal acute illness, chronic infection, heart failure of NYHA Class III or IV recent myocardial infarction or stroke during the past six months pregnancy or GDM, or any other factor likely to limit protocol compliance or reporting of adverse events
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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): 21.0-65.0, Diabetes Mellitus The diagnosis of Type 2 Diabetes Mellitus will have been determined by the following as characterized by recurrent or persistent hyperglycemia, and diagnosed by demonstrating any one of the following Fasting plasma glucose level at or above 126 mg/dL but less than 250 mg/dL on more than one determination Plasma glucose at or above 200 mg/dL two hours after a 75 g oral glucose load as in a glucose tolerance test Symptoms of hyperglycemia and casual plasma glucose at or above 200 mg/dL Glycated hemoglobin (hemoglobin A1C) at or above 6.5 but below 8.5%. (This criterion was recommended by the American Diabetes Association in 2010). 2. Adults between 21 years old 3. Have been diagnosed with Type 2 DM according to the listed above, and treated with metformin 1-2 g/daily as their only diabetic medication, and/or an approved ADA diet for no less than 30 days. 4. Documented evidence of Stage 1 or Stage 2 essential hypertension as noted below: However, the actual treatment threshold will be left to the discretion of the study investigators. Stage 1: systolic 140-159 mmHg and diastolic 90-99 mmHg Stage 2: systolic >160 mmHg and diastolic >100 mmHg However, there is accumulated evidence that patients with consistent blood pressures over 130/80 mmHg along with Type 1 or Type 2 diabetes, or kidney disease are at increased risk for progressive morbidity and mortality and require a lower threshold for further treatment. 5. Aspirin 81 mg/daily 6. Signed informed consent 7. Must maintain same diet/exercise regimen Thrombolytic therapy, GP IIb/IIIa inhibitor, thienopyridines, antifibrinolytics, COX- inhibitors, prostacyclin analogues, and vitamin K antagonists within 30 days of enrollment 2. Platelet count < 100,000/microL 3. History of bleeding disorder 4. Hct < 30%, serum creatinine ≥3 mg/dL, liver impairment defined as ALT/AST > 3 times upper limit of normal. 5. Glomerular filtration rate <60ml/min/1.73m2 6. Patients currently treated with any antiplatelet agent other than aspirin 81 mg/day 7. Admission for acute vascular syndrome (unstable angina, MI, stroke), revascularization procedure with stent placement, or other major coronary/cerebrovascular event within 30 days. 8. Active participation in other investigational drug or device trial within the last 30 days. 9. Allergy or intolerance to any of the study medications. 10. Congestive Heart Failure (NYHA I-IV) 11. Malignancies except treated non-melanoma superficial skin cancers 12. Acute infections 13. Type I diabetes, Cushings syndrome, or pancreatic deficiency due to malignancy or systemic disease 14. Insulin therapy, sulfonylureas, thiazolidinediones,meglitinides, D-phenylalanine derivatives, amylin synthetic derivatives, and incretin mimetics. 15. Pregnancy, confirmed by serum rosette inhibition assay for early pregnancy factor detectable. For women of child-bearing potential (WOCP), continuous abstinence, fertility awareness, hormonal contraceptives, and/or mechanical methods will apply to prevent pregnancy during the entire study duration. Should a subject become pregnant during the study, the anti-hypertensive treatment with either or both study medications will be discontinued immediately by the treating physician/investigator as per FDA warnings regarding potential fetal/neonatal morbidity and mortality. 16. Age over 65 years 17. History of cigarette smoking within past 10 years
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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): 19.0-65.0, Ketosis Prone Diabetes Diabetes Ketoacidosis Hyperglycemia All newly diagnosed overweight/obese (BMI >/=28 kg/m2) African-American patients with new-onset DKA and/or severe hyperglycemia and without apparent precipitating cause will be considered for into the study. The diagnosis of DKA will be established by standard (blood glucose > 250 mg/dL, pH < 7.3, HCO3 < 18 mmol/L, increased anion gap). 2. The hyperglycemic group will patients with an admission plasma glucose > 400 mg/dL but without the presence of metabolic acidosis or ketosis significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes; 2. recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism; 3. bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies; 4. pregnancy, 5. have an allergy to any component of metformin or sitagliptin
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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): 30.0-70.0, Diabetic Nephropathy male and female patients with no limitation of race, aged 30 to 70 years Type 2 diabetes defined as: > 30 years of age at diagnosis; insulin not required within 6 months of initial diagnosis; no history of diabetic ketoacidosis; currently treated with diet, oral hypoglycemics or insulin [Brenner 2000] microalbuminuria defined as urinary albumin excretion, 20 to 200 µg/min in at least 2 of 3 overnight urine samples or macroalbuminuria defined as urinary albumin excretion, > 200 µg/min in at least 2 of 3 overnight urine samples, confirmed in the baseline collection; should baseline albuminuria data not to be available, the patient may be conditionally treated glycosylated haemoglobin (Hb A1c) <12% at Screening [Brenner 2000] serum creatinine ≤ 3 mg/dL at Screening normotensive patients or hypertensive patients on stable antihypertensive therapy over the last 3 months and without specific contraindications to angiotensin antagonist therapy female patients of childbearing potential required to have a negative pregnancy test and use an approved birth control method patients legally able to give written informed consent to the trial (signed and dated by the patient) Patients cannot enter the trial under the following circumstances patients hypersensitive or allergic to ARBs or bindarit or its components, or with a positive history for drug allergy Type 1 diabetes [Brenner 2000] history of non diabetic renal disease, including renal artery stenosis [Brenner 2000] history of heart failure before enrolment [Brenner 2000] acute myocardial infarction, coronary artery bypass grafting within the past one month [Brenner 2000] cerebral vascular accident or coronary angioplasty within the past six months month [Brenner 2000] Transient Ischemic Attacks (TIA) in the past 12 months [Brenner 2000] primary aldosteronism or pheocromocytoma [Brenner 2000] severe uncontrolled hypertension (sitting diastolic blood pressure > 115 and/or sitting systolic blood pressure> 220 mm Hg) in the previous 6 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): 18.0-70.0, Hepatic Encephalopathy Patients diagnosed as having cirrhosis of liver at the Inpatient/Outpatient Liver Clinic of Department of Hepatology, Chandigarh, will be candidates for enrollment The diagnosis of cirrhosis of liver will be based on clinical, biochemical, and ultrasonographical or liver histological data Alcohol intake during the past 6 weeks Hepatocellular carcinoma Previous transjugular intrahepatic portosystemic shunt or shunt surgery Significant comorbid illness such as heart, respiratory, or renal failure Any neurologic diseases such as Alzheimer's disease, Parkinson's disease, and nonhepatic metabolic encephalopathies Patients on psychoactive drugs, such as antidepressants or sedatives Those who restart alcohol consumption during follow-up will also be excluded
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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): 18.0-120.0, Kidney Cancer Histologically or cytologically confirmed renal cell carcinoma Clear cell or non-clear cell allowed No disease of the collecting duct or medullary carcinoma Considered pathologically either intermediate high-risk or very high-risk disease No history of distant metastases Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes Surgical margins must be negative Patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive) Patients must be registered within 84 days after the date of the first surgical resection of the first tumor
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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 2 Has type 2 diabetes with glycosylated hemoglobin ≥7.0 % to ≤ 11.0% at Screening Has been on a stable diabetic diet/exercise program If receiving anti-glycemic therapy, he/she must be on ≤ two (2) anti-glycemic agents and be on a stable regimen for a minimum of 8 weeks prior to Screening Has clinical laboratory evaluations at Screening (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory unless the results are deemed not clinically significant for into this study by the investigator A female subject of childbearing potential who is sexually active agrees to use adequate contraception from screening throughout the duration of the study Currently taking or is expected to take thiazolidinediones within 12 weeks of Screening Hypersensitive to thiazolidinediones Hypertension with diastolic blood pressure >100 mm Hg and/or systolic blood pressure >170 mm Hg at Screening and/or Visit 2 (Day 1) Currently taking an angiotensin II-receptor blocker (ARB) and is not willing to discontinue therapy at Visit 2 (day 1) and remain off for the duration of the study Hypersensitive to angiotensin II-receptor blocker Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV History of myocardial infarction, cerebrovascular accident , percutaneous coronary intervention, coronary artery bypass graft or transient ischemic attack within the previous six months Clinically significant cardiac conduction defects Body mass index >45 kg/m2 at Screening Moderate to severe renal 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): 18.0-50.0, Hyperglycemia Lean, healthy, non-diabetic male Family history of diabetes, BMI over 25
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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): 60.0-999.0, Diabetes Hyperglycemia Males or females > 60 years of age. 2. Blood glucose > 150 mg/dl and A1C > 7.5%. 3. A known history of T2DM, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin). 4. Patients admitted for non-cardiac elective or emergency surgery or trauma Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia). 2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26). 3. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl). 4. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism
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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): 20.0-80.0, Hyperlipidemia All subjects will need to be on their usual diet and 1. Not have been on any cholesterol lowering medications for at least two months or eight weeks prior to randomization. The subjects will also need to be off of all dietary supplements or vitamins containing any of the constituents in any of the formulations for the same time period. 2. Any baseline cholesterol measurement will be acceptable since there is no convincing evidence of low cholesterol below which a clinical benefit is thought not to occur, nor cellular function compromised,. 3. Males 20 to 80 years of age will be acceptable. 4. Post menopausal females 55 to 80 years of age Prior myocardial infarction clinically or by EKG including left bundle branch block. 2. History of angina. 3. History of abnormal stress test consistent with ischemia or myocardial infarction. 4. Diabetes (because of the generally accepted significant association with previously undiagnosed coronary artery disease). 5. Peripheral vascular disease (because of the generally accepted significant association with previously undiagnosed coronary artery disease). 6. History of prior allergy or sensitivity to any component of any formulation. 7. Those taking medications of the following types or closely related medications: 1. cyclosporins 2. fibrates 3. Azole antifungals 4. macrolide antibiotics 5. anti-arrhythmic medications 6. Nefazodin 7. protease inhibitors 8. Coumadin 9. Seizure medication 8. Pre-randomization CPK greater than the upper limits of normal. 9. History of hepatitis or unexplained elevation of transaminase LFTs. 10. History of musculoskeletal condition with weakness or pain, i.e., arthritis, myositis, myalgia, fibromyalgia or PMR. 11. Active cancer or vasculitis on therapy. 12. Inability to provide informed consent. 13. Premenopausal women, women who are pregnant, may become pregnant or nursing mothers will be excluded because of the unknown effects of nutraceuticals on the fetus or newborn. 14. Any travel plans by the subject that would affect compliance with the study protocol. 15. History of a seizure disorder. 16. End stage renal disease (or renal failure). 17. Any subject who the investigator determines that discontinuing current cholesterol lowering treatment for the 16 weeks (8 weeks each for a wash out and study participation) of the study would not be safe or otherwise in the best interest of the subject
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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 2 Previous history of diabetes mellitus type 2, or they were using oral anti-diabetic or insulin had a fasting glucose greater than or equal to 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, age greater than or equal 18 years Patients with known presence of cancer, while using corticosteroids, immunosuppressants on hemodialysis, with cognitive and neurological sequelae, patients whose admission had shorter duration than 72 hours, when they came transferred from intensive care units in other protocols using insulin when no doctor would agree to join the protocol and those who do not agree to participate in 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): 18.0-65.0, Diabetes Mellitus, Type 2 Have been diagnosed with T2DM for at least 6 months prior to study screening Be on stable insulin regimens at the time of screening Have a stable weight (ie, no change more than 5% in the 3 months prior to screening) Have a glycosylated hemoglobin (A1C) of >=7% and <=10.5% at study screening Have history of Type 1 diabetes mellitus, secondary forms of diabetes, diabetic ketoacidosis, pancreas or beta cell transplantation Have a known history of more than 2 severe hypoglycemic episodes as defined by the protocol within the past year Have history of, or currently active, significant illness as determined by the Investigator
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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): 18.0-50.0, Type 1 Diabetes Type 1 diabetes 2. Age 18-50 years Smoking 2. Alcohol abuse 3. Use of medications (except insulin in diabetics)
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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): 20.0-80.0, Type 2 Diabetes Type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks > 20 years old A1C: > 7.0 % and < 11% Insulin use within 12 weeks of the screening visit Any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase levels > 2.5 times the upper limit of normal Current or prepare to pregnancy and lactation
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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): 18.0-60.0, Diabetes Mellitus, Type 1 Known Type 1 diabetic patients (male or female) treated with any type of insulin regimen, except continuous subcutaneous insulin infusion (CSII, or pump), and patients already treated with insulin glargine 2. Age: 18-60 years inclusive 3. HbA1c: 8% assessed over the past 6 month 4. At least 1 year of continuous insulin treatment 5. Willingness to accept, and ability to follow a basal bolus regimen (glargine x1 and glulisine x3 per day) self-monitoring blood glucose (SMBG) a fixed meal plan, or CHO counting 6. Signed informed consent obtained prior to any study procedure for entry in the treatment period: 1. HbA1c 8-10% assessed between week -2 and week 0 2. Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women 3. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal 4. Pregnancy test negative if women of childbearing potential History of hypersensitivity to insulin glargine and/or insulin glulisine 2. Pregnant, breast-feeding or women of childbearing potential not using efficient contraception 3. Brittle diabetes 4. Known impaired renal function defined as serum creatinine > 135 micromol/L in men and > 110 micromol/L in women at study entry 5. Known impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal at study entry 6. Diabetes ketoacidosis 7. History of drug or alcohol abuse 8. Psychiatric or mental disease 9. in another study in the past 6 months or previous in this study 10. Patient unable or unwilling to manage properly the basal bolus regimen The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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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, Type 1 Diabetes diabetes duration > 5 years HbA1c < or = 7.2% CSII treated for > 3 months Capable of being moderately, physically active for 20 minutes symptoms of diabetic late complications except simplex retinopathy pregnancy or nursing
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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, Type 2 Diabetes Age between 18 and 75 years, inclusive 2. BMI-range 27-50 kg/m² 3. patients with type 2 diabetes presenting with fasting hyperglycaemia (>126mg/dl) on metformin treatment Pre-existing insulin therapy, treatment with sulphonylureas, glitazones, 2.glinides, DPP-4-inhibitors or exenatide 3.patients with type 1 diabetes 4.Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 5. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner). A male subject who is sexually active and has not been surgically sterilised must be informed that he must either use a condom during intercourse, ensure that his partner practices contraception, or he must refrain from sexual intercourse during the trial and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by trial medication. It is strongly recommended that the female partners use a highly effective contraception (Pearl Index < 1%). 6. Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. 7. Patients have alcohol consumption (>20 g daily for males and >10 g daily for females) 8. Patients have alanine aminotransaminase (ALT) greater than ten times the upper limit of the reference range. 9.Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer. 10. Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria. 11. Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >1.8 mg/dL for males and greater than or equal to >1.5 mg/dL for females. 12.Patients have known hemoglobinopathy or chronic anemia 13.Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. 14. Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator. 15. Patients fail to satisfy the investigator of suitability to participate for any other reason
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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, Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus (defined according to the of the American Diabetes Association) Sign of a written informed consent to participate to the interventional study Liver disease Serious renal disorders (serum creatinine >2.5 mg/dL) History or evidence of previous major vascular events (myocardial infarction, transient ischemic attack, stroke) History of major bleeding Autoimmune diseases Cancer or present or recent infections Use of non-steroidal anti-inflammatory drugs, drugs interfering with cholesterol metabolism, or vitamin supplements or antiplatelet drugs in the previous 30 days
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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): 21.0-70.0, Diabetes Mellitus, Type 2 Diagnosis of type 2 diabetes mellitus Must be on a stable treatment regimen (maintained on diet/exercise therapy with or without metformin) for at least 4 weeks prior to study entry Have a glycated haemoglobin (HbA1c) value greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen Weigh 45.0 kg or more Have a Body Mass Index (BMI) greater than or equal to 18.5 and less than or equal to 40.0 kg/m2 Are willing and able to conduct self-blood glucose monitoring tests Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving use of an investigational drug or device other than the study drug used in this study, or are concurrently enrolled in any other type of medical research judged not to be compatible with this study Use of insulin for diabetic control for more than 6 consecutive days within 1 year prior to study entry Use of thiazolidinediones within 3 months, or other oral anti-diabetics (OADs), apart from metformin, within 1 month prior to study entry. Metformin is acceptable for this study Previous myocardial infarction, stroke or transient ischaemic event ('TIA'), or clinically significant coronary events or symptoms within 6 months prior to study entry Subjects who have any evidence of heart insufficiency, hypokalaemia, family history of long-QT-syndrome or are receiving other drugs which extend the QT interval Clinically significant peripheral vascular disease Clinical evidence of active diabetic proliferative retinopathy Known significant autonomic neuropathy Any patient having experienced a keto-acidotic episode requiring hospitalisation in the last 6 months Symptomatic hyperglycemia exhibited by significant osmotic symptoms (polyuria or polydipsia), unanticipated weight loss or dehydration
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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): 18.0-30.0, Type 1 Diabetes Age greater than 18 years and less than 30 years. 2. Have had diabetes for at least 1 year, and in good control (HbA1C less than 8.5 %). 3. Be on continuous subcutaneous insulin infusion using an insulin pump 4. Subjects must be otherwise healthy except for T1DM, and treated for hypothyroidism if present 5. Menstruating women must have negative pregnancy test. 6. Hemoglobin (Hb) more than 12 g/dl 7. Weight must be equal to or greater than 50 Kg Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis). 2. Hemoglobin less than 12 g/dl 3. Lack of a supportive family environment 4. Positive pregnancy test based on serum beta HCG in menstruating young women 5. Evidence or history of chemical abuse 6. HbA1c more than 8.5 % 7. Weight less than 50 Kg 8. History of gastroparesis and on medications that alter gastric emptying 9. History of Pancreatitis and impaired renal function 10. Hypoglycemic unawareness 11. History of sensitivity to 5-HT3 receptor antagonists 12. History of QT prolongation 13. Concomitant use of both Acetaminophen and vitamin C 14. Patients on glucocorticoid therapy 15. Known allergies to any of the study medication
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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): 30.0-70.0, Type 2 Diabetes Newly diagnosed type 2 diabetic patients. 2. Age between 30 and 70 years old. 3. HbA1C between 7 and 9% in OPD patients 4. If HbA1c >9.0% of blood glucose >300 mg/dL, intensive insulin therapy for 10-14 days Previous treated with anti-diabetic medication 2. Pregnant or lactation women. 3. Impaired liver function (ALT > 100 U/L) 4. Impaired renal function (Serum creatinine >2.0 mg/dL) 5. Recently suffered from MI or CVA. 6. Patients are acute intercurrent illness. 7. 2-hour C-peptide level < 2.0 ng/mL. 8. History of severe hypersensitivity to any product components. 9. History or high risk of acute pancreatitis. 10. Now use warfarin
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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 Type 2 diabetic patients attending hospitals or affiliated clinics led by PIs of the JADE Program who are living in the area with an intention to have 'regular' follow-up Aged >18 years Patients can have newly diagnosed or established disease, treated with lifestyle or blood glucose lowering drugs including oral agents with or without insulin For newly diagnosed type 2 diabetic patients, their plasma glucose levels should be: a) Fasting plasma glucose (PG) >7.0 mmol/L on 2 or more occasions, and/or b) Random (or post-OGTT 2h) PG >11.1 mmol/L on 2 or more occasions, and/or c) HbA1c >6.5% Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis Patients with reduced life expectancy (e.g. less than 6-months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life threatening conditions Patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study Patients actively enrolled in another intervention study Patients who are unwilling to return for regular follow up
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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): 20.0-34.0, Type 2 Diabetes Mellitus You are one of a sibling pair with the same mother and father, and your mother had diabetes (gestational or type 2) while she was pregnant with the younger sibling but not the older sibling Your sibling is willing to participate in the study You are between the ages of 20 and 34 years (inclusive) Your body mass index is between 20 and 29 Kg/m2 inclusive (this is a number calculated for your height and weight and indicates that you are either normal weight or overweight, but not obese) You are healthy as assessed by medical history and standard physical examination You are weight stable (your body weight has not changed .6.5 lbs over the last 3 months) You do not smoke You provide written informed consent to participate in the study You are willing to stay overnight one time at the Pennington Center You have low physical activity (< 100 min of exercise per week) You were born prematurely (<37 weeks of pregnancy) You are currently taking medication that may influence your body weight or metabolism You have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible
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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, Amyotrophic Lateral Sclerosis Aged 18 to 80 years old, inclusive, on Day 1 Diagnosis of sporadic or familial ALS Onset of first ALS symptoms within 24 months prior to Day 1 World Federation of Neurology El Escorial are met for a possible, laboratory-supported probable, probable, or definite ALS diagnosis Upright slow vital capacity (SVC) of 65% or more at screening Patients taking or not taking Riluzole are eligible for this study: if a patient has never taken Riluzole, he or she is eligible; if a patient is currently taking Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient has discontinued Riluzole, he or she must have stopped taking it for at least 30 days Must be able to swallow tablets at the time of study entry Other medically significant illness Clinically significant abnormal laboratory values Pregnant women or women breastfeeding Prior exposure to dexpramipexole Currently taking pramipexole or other dopamine agonists. Other protocol-defined inclusion/
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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, Diabetes Mellitus Type 1 diabetes for more than 5 years Body mass index of > 25 kg/m2 Insulin requirement > 0.5 U/kg bodyweight HbA1c>7.5%, stable glycemic control Inability to give informed consent Presence of any medical condition that might interfere with the current study protocol Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids) Anti-inflammatory drugs (including nonsteroidal anti-inflammatory drugs, 100 mg or less of aspirin per day is allowed) Signs of current infection (fever, C-reactive protein (CRP) > 30 mmol/l, treatment with antibiotics, previous or current diagnosis of tuberculosis A history of recurrent infections Pregnancy or breast-feeding (contraception of at least 3 months before is required for fertile women) Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range) Renal disease (creatinine > 130 µmol/l Neutropenia < 2 x 109/l
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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): 18.0-65.0, Type 1 Diabetes Mellitus Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus
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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): 18.0-40.0, Diabetes Mellitus Cardiomyopathy written informed consent no disease history BNP level within the normal range Normal renal function (serum creatinine of more than 1.3 mg/dL and/or creatinin clearance greater than 80ml/min) Normal ECG systolic blood pressure < 90 mmHg subjects on any medication abnormal glucose metabolism history of anaphylaxis
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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 Male or Female over 18 years of age Type 2 diabetes for at least 6 months Taking 1 or more oral hypoglycemic agents Patient attending your community pharmacy where you decided that addition of insulin glargine may be of benefit to the patient Baseline HbA1c 7.5 Signed informed consent Have used, or currently using, Insulin History of ketoacidosis Pregnant Works night shift Renal impairment(Serum Creatinine: females ≥ 124 mmol/l, males ≥ 133 mmol/l) Clinically unstable Unwilling/unable to attend follow up visits Unlikely to adhere to study procedures (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism)
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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, Type 1 Diabetes Male and female patients aged 18-65yr ability to provide written informed consent and comply with the study protocol procedures clinical history of type 1 diabetes with onset <40yr of age, on insulin for at least 5yr at the time of enrollment absent stimulated C-peptide (<0.5ng/ml) in response to arginine multiple (three or more) daily insulin injections or insulin pump therapy self blood glucose monitoring ≥3 times/day, supervised by a specialist physician high glycemic instability and hypoglycemia unawareness inability to consistently attain a HbA1c < 7.5 % target without experiencing severe hypoglycemia (assistance by another person) in the past 36 months despite appropriate medical management HbA1c >12% BMI >30 kg/m2, or insulin requirement of > 0.8 IU/kg/day poorly controlled hypertension untreated proliferative diabetic retinopathy presence or history of macroalbuminuria (>300mg/g day) or measured glomerular filtration rate <60 ml/min/1.73 m2 for females and <70 ml/min/1.73 m2 for males for female participants: positive pregnancy test, presently breast-feeding, or unwilling to use effective contraceptive measures for the duration of the study and 3 months after discontinuation for male participants: intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness to use effective measures of contraception any history of malignancy within the previous 5 years, except for completely resected squamous or basal cell carcinoma of the skin
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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 Type 2 diabetic patients attending the 8 hospitals or affiliated clinics led by PIs of the JADE-JA Program who are living in the area with an intention to have 'regular' follow-up Aged ≥ 18 years Patients can have newly diagnosed or established disease, treated with lifestyle or blood glucose lowering drugs including oral agents with or without insulin For newly diagnosed type 2 diabetic patients, their plasma glucose levels should be Fasting plasma glucose (PG) ≥ 7.0 mmol/L on 2 or more occasions, and/or Random (or post-OGTT 2h) PG ≥ 11.1 mmol/L on 2 or more occasions, and/or Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (> 3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis Patients with reduced life expectancy (e.g. less than 6-months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life threatening conditions Patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study Patients actively enrolled in another intervention study Patients who are unwilling to return for regular follow up
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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, Type 2 Diabetes Mellitus Hospitalization Hyperglycemia Males or females between the ages of 18 and 80 years admitted to a general medicine and surgery services. 2. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding Trazodone (TZDs) and DPP4 inhibitors), or low-dose (≤ 0.4 units/kg/day) insulin therapy. 3. Subjects with a BG >140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 milliequivalent /L or positive serum or urinary ketones) Age < 18 or > 80 years. 2. Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia). 3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) [46]. 4. History of TZD treatment (pioglitazone or rosiglitazone) or DPP4 inhibitor (sitagliptin or saxagliptin) during the past 3 months prior to admission. 5. Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require prolonged admission to a critical care unit (ICU, cardiac care unit , surgical intensive care unit, neuro ICU). 6. Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction. 7. Medical or surgical patients expected to be kept nil per os (NPO) for >24-48 hours after admission or after completion of surgical procedure. 8. Patients with clinically relevant pancreatic or gallbladder disease. 9. Patients with congestive heart failure (NYHA class III and IV), acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (serum creatinine ≥ 2.0 mg/dL). 10. Treatment with oral or injectable corticosteroid. 11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 12. Female subjects are pregnant or breast feeding at time of enrollment into 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): 4.0-16.0, Type 1 Diabetes The are: Diagnosis of type I diabetes for at least two years prior to enrollment, the ability tolerate wearing the continuous blood glucose monitoring device for a total of 6 days, and the ability to follow a prescribed meal plan The are: Medical conditions that could potentially affect the absorption of nutrients such as celiac disease of inflammatory bowel disease and the use of any fiber supplements at home
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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 Symptoms of diabetes plus casual plasma glucose concentration ≥ 200 mg/dl (11.1 mmol/l), or; 2. FPG ≥ 126 mg/dl (7.0 mmol/l), or; 3. 2-h postload glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT. In addition, subjects would be required to be at increased risk of cardiovascular events, defined as microalbuminuria, or T1DM duration of > 20 years HIV infection 2. Gilbert's syndrome 3. Hepatic failure or active hepatitis, 4. Unstable cardiovascular disease, including angina, heart failure or arrhythmia 5. drug abuse including alcoholism or addiction to cocaine, heroin or amphetamines 6. Use of medications that significantly with atazanavir 7. Pregnancy, or inability to practice adequate contraception
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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): 1.0-24.0, Type 1 Diabetes Type 1 diabetes being treated by the Association Rwandese des Diabetiques Resident of Rwanda life expectancy less than three years requiring additional diabetes therapy beyond the scope of the trial
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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, Hospital Hyperglycemia Post-transplant Hyperglycemia Undergoing liver transplant or combined liver-kidney transplant Unable to grant informed consent or comply with study procedure Allergic to any of the excipients in insulin
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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 2 Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study Have been receiving at least 2 OAMs for at least 3 months before entering the study Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss Have had any episodes of severe hypoglycemia within 6 months prior to screening Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification) Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL) Have obvious clinical signs or symptoms of liver disease (excluding non alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
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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): 21.0-64.0, Type 1 Diabetes Mellitus Type I diabetes mellitus (TIDM) (as defined by the American Diabetes Association or judgment of a physician) for at least two years prior to the enrollment in the study Use of an insulin pump to treat their diabetes for at least six months prior to the study Ability to use a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor Age 21 years. Adults age 65 and over are likely to have medical exclusions for the follow-up Phase 2 study, which involves induced hypoglycemia Completed Phase 1 of the Institutional Review Board (IRB) #14956 "Development of a Behavioral Observer for Type 1 Diabetes Mellitus" Willingness to use lispro (Humalog) insulin two days prior to and during inpatient admission Willingness to perform Self-Monitoring Blood Glucose (SMBG) 4 times per day at times before meals and bedtime Demonstration of proper mental status and cognition for completion of the study Pregnancy Psychiatric disorders that would interfere with study tasks (e.g. mental retardation, substance abuse) History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans Known bleeding diathesis or dyscrasia Active enrollment in another clinical trial Medical condition that would make operating an insulin pump difficult (e.g. blindness, severe arthritis, extensive scar tissue at sites where devices are inserted) Anemia (hematocrit <36% [females], <38% [males]) Allergy or adverse reaction to lispro (Humalog) insulin Conditions which may increase the risk of induced hypoglycemia such as symptomatic heart disease, congestive heart failure, history of a cerebrovascular event, atrial fibrillation, renal insufficiency (creatinine >1.5) or uncontrolled hypertension (resting blood pressure >140/90)
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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, Insulin Sensitivity Multiple Mitochondrial Dysfunctions Syndrome T2DM Drug Naive Or On Oral Therapy Insulin Treatment Major Organ 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): 18.0-65.0, Type 1 Diabetes Mellitus Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative On insulin pump therapy for at least 3 months Non-type 1 diabetes mellitus Any physical/psychological disease likely to interfere with the study Taking medication likely to interfere with interpretation of the results Known/suspected allergy against insulin Patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator Ongoing severe recurrent hypoglycaemia as judged by the investigator
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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): 21.0-65.0, Type 1 Diabetes Mellitus Patient must be aged between 21 (inclusive) and 65 years old. The age of 21 has been chosen because this trial is supported by a US Foundation Patient must have been clinically diagnosed with Type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met for documented hyperglycemia (at least 1 must be met) Fasting glucose ≥126 mg/dL confirmed Two-hour OGTT glucose ≥200 mg/dL confirmed HbA1c ≥6.5% documented confirmed Random glucose ≥200 mg/dL with symptoms Diabetic ketoacidosis within the 6 months prior to enrollment Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment Pregnancy, breast feeding, or intention of becoming pregnant Uncontrolled arterial hypertension (diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg) Conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the DexCom CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants) Anticoagulant therapy other than aspirin Oral steroids Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions
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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
|
eligible ages (years): 21.0-65.0, Type 1 Diabetes Mellitus Patient must be aged between 21 (inclusive) and 65 years old. The age of 21 has been chosen because this trial is supported by a US Foundation Patient must have been clinically diagnosed with Type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met for documented hyperglycemia (at least 1 must be met) Fasting glucose ≥126 mg/dL confirmed Two-hour Oral Glucose Tolerance Test (OGTT) glucose ≥200 mg/dL confirmed HbA1c ≥6.5% documented confirmed Random glucose ≥200 mg/dL with symptoms Diabetic ketoacidosis within the 6 months prior to enrollment Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment Pregnancy, breast feeding, or intention of becoming pregnant Uncontrolled arterial hypertension (diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg) Conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the DexCom CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants) Anticoagulant therapy other than aspirin Oral steroids Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions
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1
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