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OTC, over the counter; NA, data not available; Rx, prescription; t.i.d., three times daily, p.o., by mouth; SC, subcutaneous injection; AWP, average wholesale price; NADAC, National Average Drug AcquisitionCost. *Use lowest effective dose; maximum appropriate dose is 37.5 mg. Weight loss data were extracted from the 12... | [
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mg. Weight loss data were extracted from the 12-week time point, as phentermine is approved for use for up to 12 weeks. †Enrolled partic- | [
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ipants had normal (79%) or impaired (21%) glucose tolerance. ‡Maximum dose, depending on response, is 15 mg/92 mg q.d. §Approximately 68% of enrolled participants had type 2 diabetes or impaired glu- | [
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cose tolerance. jjAgent has indication for reduction of cardiovascular events (49,151). AWP and NADAC prices for 30-day supply of maximum or maintenance dose as of 6 Sep tember 2023.S152 Obesity and Weight Management for Type 2 Diabetes Diabetes Care Volume 47, Supplement 1, January 2024\n©AmericanDiabetesAssociation | [
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for those with severe hypoglycemia\nor hypoglycemia unawareness. E\n8.24 In people who undergo metabolic\nsurgery, routinely screen for psychoso-cial and behavioral health changes and\nrefer to a quali fied behavioral health\nprofessional as needed. C\n8.25 Monitor individuals who have\nundergone metabolic surgery for i... | [
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8.25 Monitor individuals who have\nundergone metabolic surgery for in-\nsufficient weight loss or weight recur-\nrence at least every 6 –12 months. E\nIn those who have insuf ficient weight | [
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In those who have insuf ficient weight\nloss or experience weight recurrence,assess for potential predisposing fac-tors and, if appropriate, consider addi-tional weight loss interventions (e.g.,obesity pharmacotherapy). C\nSurgical procedures for obesity treat-\nment —often referred to interchangeably\nas bariatric surg... | [
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as bariatric surgery, weight loss surgery,\nmetabolic surgery, or metabolic/bariatric\nsurgery —can promote signi ficant and du-\nrable weight loss and improve type 2 dia-betes. Given the magnitude and rapidity\nof improvement of hyperglycemia and\nglucose homeostasis, these procedures\nhave been suggested as treatments... | [
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have been suggested as treatments for\ntype 2 diabetes even in the absence ofsevere obesity, hence the current pre-\nferred terminology of “metabolic sur-\ngery”(89).\nA substantial body of evidence, includ-\ning data from numerous large cohort\nstudies and randomized controlled (non-\nblinded) clinical trials, demonst... | [
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blinded) clinical trials, demonstrates that\nmetabolic surgery achieves superior gly-\ncemic management and reduction of car-\ndiovascular risk in people with type 2diabetes and obesity compared with non-\nsurgical intervention (45). In addition to\nimproving glycemia, metabolic surgery re-\nduces the incidence of micr... | [
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duces the incidence of microvascular dis-\nease (90), improves quality of life (45,91,92),\ndecreases cancer risk, and improves car-\ndiovascular disease risk factors and long-\nterm cardiovascular events (93 –104).\nCohort studies that match surgical andnonsurgical subjects strongly suggest that | [
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metabolic surgery reduces all-cause mor-tality (105,106).\nThe overwhelming majority of proce-\ndures in the U.S. are vertical sleeve gastrec-tomy (VSG) and Roux-en-Y gastric bypass\n(RYGB). Both procedures result in an ana-\ntomically smaller stomach pouch and often\nrobust changes in enteroendocrine hor- | [
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robust changes in enteroendocrine hor-\nmones. In VSG, /C2480% of the stomach isremoved, leaving behind a long, thin\nsleeve-shaped pouch. RYGB creates amuch smaller stomach pouch (roughlythe size of a walnut), which is thenattached to the distal small intestine,\nthereby bypassing the duodenum and\njejunum.\nMetabolic... | [
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jejunum.\nMetabolic surgery has been demon-\ns t r a t e dt oh a v eb e n e ficial effects on type 2\ndiabetes irrespective of the presurgicalBMI (107). The American Society for Met-abolic and Bariatric Surgery is now recom-mending metabolic surgery for people\nwith type 2 diabetes and a BMI $30 kg/m\n2\n(or$27.5 kg/m2f... | [
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2\n(or$27.5 kg/m2for Asian American indi-\nviduals) in surgically eligible individuals.\nStudies have documented diabetes remis-sion after 1 –5y e a r si n3 0 –63% of individ-\nuals with RYGB (17,108).\nMost notably, the Surgical Treatment\nand Medications Potentially Eradicate Di-abetes Ef ficiently (STAMPEDE) trial, w... | [
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randomized 150 participants with poorlymanaged diabetes to receive either meta-bolic surgery or medical treatment, foundthat 29% of those treated with RYGB and23% treated with VSG achieved A1C of\n6.0% or lower after 5 years (45). Available\ndata suggest an erosion of diabetes re-mission over time (46); at least 35 –50... | [
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of individuals who initially achieve remis-\nsion of diabetes eventually experience re-\ncurrence. Still, the median disease-freeperiod among such individuals followingRYGB is 8.3 years (109,110), and the major-\nity of those who undergo surgery maintain\nsubstantial improvement of glycemiafrom baseline for at least 5 ... | [
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(45,91,94,95,110– 113).\nExceedingly few presurgical predictors\nof success have been identi fied, but youn-\nger age, shorter duration of diabetes (e.g.,<8 years) (84), and lesser severity of dia-\nbetes (better glycemic control, not using\ninsulin) are associated with higher rates | [
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insulin) are associated with higher rates\nof diabetes remission (45,94,112,114).Greater baseline visceral fat area mayalso predict improved postoperative out-\ncomes, especially among Asian American\npeople with type 2 diabetes (115).\nAlthough surgery has been shown to\nimprove the metabolic pro files and car- | [
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improve the metabolic pro files and car-\ndiovascular risk of people with type 1 dia-\nbetes, larger and longer-term studies are\nneeded to determine the role of meta-bolic surgery in such individuals (116).\nWhereas metabolic surgery has greater\ninitial costs than nonsurgical obesity treat-\nments, retrospective analy... | [
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ments, retrospective analyses and model-\ning studies suggest that surgery may becost-effective or even cost-saving for indi-viduals with type 2 diabetes. However,these results largely depend on assump-tions about the long-term effectivenessand safety of the procedures (117,118).\nThe safety of metabolic surgery has im... | [
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The safety of metabolic surgery has im-\nproved signi ficantly with continued re fine-\nment of minimally invasive (laparoscopic)approaches, enhanced training andcredentialing, and involvement of inter-\nprofessional teams. Perioperative mortal-\nity rates are typically 0.1 –0.5%, similar to | [
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ity rates are typically 0.1 –0.5%, similar to\nthose of common abdominal proceduressuch as cholecystectomy or hysterectomy\n(119–123). Major complications occur in\n2–6% of those undergoing metabolic sur-\ngery, which compares favorably with the\nrates for other commonly performed elec-\ntive operations (123). Postsurg... | [
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tive operations (123). Postsurgical recovery\ntimes and morbidity have also dramaticallydeclined. Minor complications and needfor operative reintervention occur in upto 15% (119– 128). Empirical data suggest\nthat the pro ficiency of the operating sur- | [
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that the pro ficiency of the operating sur-\ngeon and surgical team is an important fac-tor in determining mortality, complications,reoperations, and readmissions (129). Ac-\ncordingly, metabolic surgery should be\nperformed in high-volume centers withinterprofessional teams experienced inmanaging diabetes, obesity, and... | [
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testinal surgery. Refer to the American\nCollege of Surgeons website for informa-tion on accreditation and to locate an ac-credited program (https://www.facs.org/quality-programs/accreditation-and-\nverifi cation/metabolic-and-bariatric-surgery-\naccreditation-and-quality-improvement-\nprogram/).\nBeyond the perioperati... | [
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program/).\nBeyond the perioperative period, longer-\nterm risks include vitamin and mineral de fi-\nciencies, anemia, osteoporosis, dumpingsyndrome, and severe hypoglycemia (130).Nutritional and micronutrient de ficiencies\nand related complications occur with a vari-\nable frequency depending on the type of | [
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able frequency depending on the type of\nprocedure and require routine monitoringof micronutrient and nutritional status andlifelong vitamin/nutritional supplementa-\ntion (130). Dumping syndrome usually oc-\ncurs shortly (10 –30 min) after a meal and | [
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curs shortly (10 –30 min) after a meal and\nmay present with diarrhea, nausea, vom-iting, palpitations, and fatigue; hypoglyce-mia is usually not present at the time of\nsymptoms but, in some cases, may de-\nvelop several hours later. Post –metabolic\nsurgery hypoglycemia can occur withRYGB, VSG, and other gastrointest... | [
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procedures and may severely impact\nquality of life (131 –133). Post –metabolicdiabetesjournals.org/care Obesity and Weight Management for Type 2 Diabetes S153\n©AmericanDiabetesAssociation | [
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surgery hypoglycemia is driven in part by\naltered gastric emptying of ingestednutrients, leading to rapid intestinal\nglucose absorption and excessive post-\nprandial secretion of GLP-1 and othergastrointestinal peptides. As a result, over-stimulation of insulin release and a sharp\ndrop in plasma glucose occur, most ... | [
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drop in plasma glucose occur, most com-\nmonly 1 –3 h after a high-carbohydrate\nmeal. Symptoms range from sweating,tremor, tachycardia, and increased hunger\nto impaired cognition, loss of conscious-\nness, and seizures. In contrast to dumpingsyndrome, which often occurs soon aftersurgery and improves over time, post ... | [
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bariatric surgery hypoglycemia typically\npresents >1 year post-surgery. Diagnosis\nis primarily made by a thorough history,\ndetailed records of food intake, physicalactivity, and symptom patterns, and ex-\nclusion of other potential causes (e.g., | [
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clusion of other potential causes (e.g.,\nmalnutrition, side effects of medicationsor supplements, dumping syndrome, andinsulinoma). Initial management includes\neducation to facilitate reduced intake of\nrapidly digested carbohydrates while en-suring adequate intake of protein andhealthy fats, and vitamin/nutrient sup... | [
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ments. When available, individuals should\nbe offered medical nutrition therapy withad i e t i t i a ne x p e r i e n c e di np o s t –bariatric sur-\ngery hypoglycemia and the use of continu-ous glucose monitoring (ideally real-time\ncontinuous glucose monitoring, which can | [
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continuous glucose monitoring, which can\ndetect dropping glucose levels before severehypoglycemia occurs), especially for thosewith hypoglycemia unawareness. Medica-\ntion treatment, if needed, is primarily aimed\nat slowing carbohydrate absorption (e.g.,acarbose) or reducing GLP-1 and insulin se-cretion (e.g., diazox... | [
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People who undergo metabolic surgery\nmay also be at increased risk for sub-\nstance abuse, worsening or new-onset\ndepression and/or anxiety disorders, andsuicidal ideation (130,135 –140). Candi-\ndates for metabolic surgery should be as-sessed by a behavioral health professional\nwith expertise in obesity management | [
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with expertise in obesity management\nprior to consideration for surgery (141).\nSurgery should be postponed in individu-\nals with alcohol or substance use disor-\nders, severe depression, suicidal ideation,\nor other signi ficant behavioral health con-\nditions until these conditions have beensufficiently addressed. In... | [
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preoperative or new-onset psychopathol-\nogy should be assessed regularly followings u r g e r yt oo p t i m i z eb e h a v i o r a lh e a l t ha n dpostsurgical outcomes.\nReferences\n1. Narayan KM, Boyle JP, Thompson TJ, Gregg\nEW, Williamson DF. Effect of BMI on lifetime risk\nfor diabetes in the U.S. Diabetes Care ... | [
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0.07436956465244293,
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0.05483... |
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0.046410296112298965,
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0.07582814991474152,
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-0.021982911974191666,
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0.07018754631280899,
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0.02460283413529396,
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0.08663905411958694,
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0.04166919365525246,
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0.007201032713055611,
0.06533145159482956,
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0.12228136509656906,
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0.07615267485380173,
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-0.039337... |
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0.03936442732810974,
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0.0200... |
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0.02068622037768364,
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-0.027162136510014534,
0.020027711987495422,
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0.07681018114089966,
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0.0079101687297225,
-0.03175918757915497,
0.01193... |
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0.044152986258268356,
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Lancet Diabetes Endocrinol 2023;11:226– 228S154 Obesity and Weight Management for Type 2 Diabetes Diabetes Care Volume 47, Supplement 1, January 2024\n©AmericanDiabetesAssociation | [
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9. Pharmacologic Approaches to\nGlycemic Treatment: Standards\nof Care in Diabetes— 2024\nDiabetes Care 2024;47(Suppl. 1):S158 –S178 |https://doi.org/10.2337/dc24-S009American Diabetes Association\nProfessional Practice Committee *\nThe American Diabetes Association (ADA) “Standards of Care in Diabetes” in- | [
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cludes the ADA ’s current clinical practice recommendations and is intended to\nprovide the components of diabetes care, general treatment goals and guide-\nlines, and tools to evaluate quality of care. Members of the ADA ProfessionalPractice Committee, an interprofessional expert committee, are responsible for | [
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updating the Standards of Care annually, or more frequently as warranted. For a\ndetailed description of ADA standards, statements, and reports, as well as theevidence-grading system for ADA ’s clinical practice recommendations and a full | [
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list of Professional Practice Committee members, please refer to Introductionand Methodology. Readers who wish to comment on the Standards of Care areinvited to do so at professional.diabetes.org/SOC.\nPHARMACOLOGIC THERAPY FOR ADULTS WITH TYPE 1 DIABETES\nRecommendations\n9.1Treat most adults with type 1 diabetes with... | [
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sulin infusion or multiple daily doses of prandial (injected or inhaled) and\nbasal insulin. A\n9.2For most adults with type 1 diabetes, insulin analogs (or inhaled insulin)\nare preferred over injectable human insulins to minimize hypoglycemia risk. A\n9.3Early use of continuous glucose monitoring is recommended for a... | [
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with type 1 diabetes to improve glycemic outcomes and quality of life andminimize hypoglycemia. B\n9.4Automated insulin delivery systems should be considered for all adults\nwith type 1 diabetes. A\n9.5To improve glycemic outcomes and quality of life and minimize hypoglyce-\nmia risk, most adults with type 1 diabetes s... | [
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to match mealtime insulin doses to carbohydrate intake and, additionally, tofat and protein intake. They should also be taught how to modify the insulindose (correction dose) based on concurrent glycemia, glycemic trends (if\navailable), sick-day management, and anticipated physical activity. B | [
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available), sick-day management, and anticipated physical activity. B\n9.6Glucagon should be prescribed for all individuals taking insulin or at high\nrisk for hypoglycemia. Family, caregivers, school personnel, and others provid-\ning support to these individuals should know its location and be educated on | [
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how to administer it. Glucagon preparations that do not require reconstitu-\ntion are preferred. E\n9.7Insulin treatment plan and insulin-taking behavior should be reevaluated at\nregular intervals (e.g., every 3 –6 months) and adjusted to incorporate speci fic*A complete list of members of the American | [
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Diabetes Association Professional Practice Committeecan be found at https://doi.org/10.2337/dc24-SINT.\nDuality of interest information for each author is\navailable at https://doi.org/10.2337/dc24-SDIS.\nSuggested citation: American Diabetes Association\nProfessional Practice Committee. 9. Pharmacologicapproaches to g... | [
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Care in Diabetes —2024. Diabetes Care 2024;47\n(Suppl. 1):S158– S178\n© 2023 by the American Diabetes Association.Readers may use this article as long as thework is properly cited, the use is educationaland not for pro fit, and the work is not altered. | [
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More information is available at https://www.diabetesjournals.org/journals/pages/license.9. PHARMACOLOGIC APPROACHES TO GLYCEMIC TREATMENTS158 Diabetes Care Volume 47, Supplement 1, January 2024\n©AmericanDiabetesAssociation | [
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factors that impact choice of treat-\nment and ensure achievement of in-dividualized glycemic goals. E\nInsulin Therapy\nInsulin treatment is essential for individu-\nals with type 1 diabetes because thehallmark of type 1 diabetes is absent ornear-absent b-cell function. In addition | [
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to hyperglycemia, insulinopenia can con-tribute to other metabolic disturbanceslike hypertriglyceridemia and ketoacido-\nsis as well as tissue catabolism that can\nbe life threatening. Severe metabolic de-compensation can be, and was, mostly\nprevented with once- or twice-daily in- | [
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prevented with once- or twice-daily in-\njections for the six or seven decades af-ter the discovery of insulin. Over thepast four decades, evidence has accumu-\nlated supporting more intensive insulin\nreplacement, using multiple daily injec-tions of insulin or continuous subcutane-\nous administration through an insul... | [
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ous administration through an insulin\npump, as providing the best combinationof effectiveness and safety for peoplewith type 1 diabetes.\nThe Diabetes Control and Complications\nTrial (DCCT) demonstrated that intensivetherapy with multiple daily injections orcontinuous subcutaneous insulin infusion\n(CSII) reduced A1C... | [
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(CSII) reduced A1C and was associated\nwith improved long-term outcomes (1 –3).\nThe study was carried out with short-acting\n(regular) and intermediate-acting (NPH)\nhuman insulins. In this landmark trial,lower A1C with intensive control (7%) ledto/C2450% reductions in microvascular com- | [
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plications over 6 years of treatment. How-ever, intensive therapy was associatedwith a higher rate of severe hypoglycemia\nthan conventional treatment (62 com-\npared with 19 episodes per 100 patient-years of therapy) (1). Follow-up of partici-\npants from the DCCT demonstrated fewer | [
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pants from the DCCT demonstrated fewer\nmacrovascular and microvascular compli-cations in the group that received intensivetreatment. Achieving intensive glycemic\ngoals during the active treatment period of\nthe study had a bene ficial impact over the\n20 years after the active treatment compo-\nnent of the study ended... | [
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nent of the study ended (1 –3).\nInsulin replacement plans typically con-\nsist of basal insulin, mealtime insulin, and\ncorrection insulin (4). Basal insulin includes\nNPH insulin, long-acting insulin analogs,\nand continuous delivery of rapid-acting in-sulin via an insulin pump. Basal insulinanalogs have longer durat... | [
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withflatter, more constant and consistentplasma concentrations and activity pro-\nfiles than NPH insulin; rapid-acting analogs\n(RAA) have a quicker onset and peak ands h o r t e rd u r a t i o no fa c t i o nt h a nr e g u l a rh u -man insulin. In people with type 1 diabe-\ntes, treatment with analog insulins is | [
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tes, treatment with analog insulins is\nassociated with less hypoglycemia andweight gain as well as lower A1C com-pared with injectable human insulins\n(5–7). More recently, two injectable ultra-\nrapid-acting analog (URAA) insulin formu-\nlations were developed to accelerate ab-sorption and provide more activity in th... | [
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first portion of their profi le compared with\nthe other RAA (8,9). Inhaled human insulin\nhas a rapid peak and shortened durationof action compared with RAA (10) (seealso subsection\nALTERNATIVE INSULIN ROUTES in\nPHARMACOLOGIC THERAPY FOR ADULTS WITH TYPE 2\nDIABETES ). These newer formulations may | [
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DIABETES ). These newer formulations may\ncause less hypoglycemia, while improvingpostprandial glucose excursions and ad-\nministration flexibility (in relation to pran-\ndial intake), compared with RAA (10 –12).\nIn addition, longer-acting basal analogs\n(U-300 glargine or degludec) may confer a\nlower hypoglycemia ris... | [
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lower hypoglycemia risk compared with\nU-100 glargine in individuals with type 1diabetes (13,14).\nDespite the advantages of insulin ana-\nlogs in individuals with type 1 diabetes,\nthe expense and/or intensity of treat- | [
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the expense and/or intensity of treat-\nment required for their use may be pro-hibitive. There are multiple approachesto insulin treatment. The central preceptin the management of type 1 diabetes is\nthat some form of insulin be given in a\ndefined treatment plan tailored to the | [
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defined treatment plan tailored to the\nindividual to prevent diabetic ketoacido-sis (DKA) and minimize clinically relevant\nhypoglycemia while achieving the indi-\nvidual ’s glycemic goals. The impact of the\nintroductionofinterchangeablebiosimilarsand unbranded versions of some analog\nproducts as well as current and ... | [
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... |
products as well as current and upcoming\nprice reductions on insulin access need tobe evaluated. Reassessment of insulin-taking behavior and adjustment of treat-ment plans to account for speci ficf a c t o r s ,\nincluding cost, that impact choice of treat-ment is recommended at regular intervals(every3 –6months). | [
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Most studies comparing multiple daily\ninjections with CSII have been relatively\nsmall and of short duration. A systematic\nreview and meta-analysis concluded thatCSII via pump therapy has modest advan-tages for lowering A1C ( /C00.30% [95% CI\n/C00.58 to /C00.02]) and for reducing severe | [
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/C00.58 to /C00.02]) and for reducing severe\nhypoglycemia rates in children and adults(15). Use of CSII is associated with im-provement in quality of life, particularly inareas related to fear of hypoglycemia anddiabetes distress, compared with multipledaily injections of insulin (16,17). How-\never, there is no conse... | [
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ever, there is no consensus to guide the\nchoice of injection or pump therapy in agiven individual, and research to guidethis decision-making is needed (4). Inte-\ngration of continuous glucose monitoring\n(CGM) into the treatment plan soon afterdiagnosis improves glycemic outcomes,decreases hypoglycemic events, and im... | [
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proves quality of life for individuals with\ntype 1 diabetes (18 –23). Its use is now\nconsidered standard of care for most peo-ple with type 1 diabetes (4) (see Section 7,\n“Diabetes Technology ”). Reduction of noc-\nturnal hypoglycemia in individuals with | [
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turnal hypoglycemia in individuals with\ntype 1 diabetes using insulin pumps withCGM is improved by automatic suspensionof insulin delivery at a preset glucose level,\nwith further improvements when using de-\nvices with predictive low glucose insulindelivery suspension (24,25).\nAutomated insulin delivery (AID) system... | [
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Automated insulin delivery (AID) systems\nare safe and effective for people with type1 diabetes. Randomized controlled trialsand real-world studies have demonstratedthe ability of commercially available sys-tems to improve achievement of glycemic\ngoals while reducing the risk of hypoglyce-\nmia (26 –31). Data are emer... | [
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mia (26 –31). Data are emerging on the\nsafety and effectiveness of do-it-yourselfsystems (32,33). Evidence suggests that an\nAID hybrid closed-loop system is superior\nto AID sensor-augmented pump therapyfor increased percentage of time in rangeand reduction of hypoglycemia (34,35).\nIntensive insulin management using... | [
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Intensive insulin management using a\nversion of CSII and CGM should be consid-ered in individuals with type 1 diabeteswhenever feasible. AID systems are pre-ferred and should be considered for indi-\nviduals with type 1 diabetes who are | [
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viduals with type 1 diabetes who are\ncapable of using the device safely (eitherby themselves or with a caregiver) to im-p r o v et i m ei nr a n g ea n dr e d u c eA 1 Ca n d\nhypoglycemia (26,28 –31,36– 42). When\nchoosing among insulin delivery systems, | [
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