9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2020

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc20-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc20-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

[1]  C. Mathieu,et al.  2019 Update to: Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) , 2019, Diabetes Care.

[2]  M. Stumvoll,et al.  Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial , 2019, The Lancet.

[3]  R. Pratley,et al.  Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial , 2019, The Lancet.

[4]  J. Rosenstock,et al.  A Model‐Based Meta‐Analysis of 24 Antihyperglycemic Drugs for Type 2 Diabetes: Comparison of Treatment Effects at Therapeutic Doses , 2019, Clinical pharmacology and therapeutics.

[5]  W. Kernan,et al.  Correction to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) , 2019, Diabetologia.

[6]  B. Zinman,et al.  Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials , 2018, Diabetes Care.

[7]  Geltrude Mingrone,et al.  Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) , 2018, Diabetes Care.

[8]  Janet M. Allen,et al.  Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial , 2018, The Lancet.

[9]  S. Garg,et al.  Improved Postprandial Glucose with Inhaled Technosphere Insulin Compared with Insulin Aspart in Patients with Type 1 Diabetes on Multiple Daily Injections: The STAT Study , 2018, Diabetes technology & therapeutics.

[10]  J. Lobo,et al.  Cost-related medication non-adherence among U.S. adults with diabetes. , 2018, Diabetes research and clinical practice.

[11]  Melissa M. Parker,et al.  Association of Initiation of Basal Insulin Analogs vs Neutral Protamine Hagedorn Insulin With Hypoglycemia-Related Emergency Department Visits or Hospital Admissions and With Glycemic Control in Patients With Type 2 Diabetes , 2018, JAMA.

[12]  W. Herman,et al.  Insulin Access and Affordability Working Group: Conclusions and Recommendations , 2018, Diabetes Care.

[13]  H. R. C. Nunes,et al.  Effectiveness and safety of carbohydrate counting in the management of adult patients with type 1 diabetes mellitus: a systematic review and meta-analysis , 2018, Archives of endocrinology and metabolism.

[14]  Jingli Lu,et al.  Effect of metformin on glycaemic control in patients with type 1 diabetes: A meta‐analysis of randomized controlled trials , 2018, Diabetes/metabolism research and reviews.

[15]  William H. Herman,et al.  The Cost of Diabetes Care—An Elephant in the Room , 2018, Diabetes Care.

[16]  C. Stehouwer,et al.  Long-term treatment with metformin in type 2 diabetes and methylmalonic acid: Post hoc analysis of a randomized controlled 4.3year trial. , 2018, Journal of diabetes and its complications.

[17]  M. Phillip,et al.  Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. , 2017, The lancet. Diabetes & endocrinology.

[18]  R. Klein,et al.  Cardiovascular and metabolic effects of metformin in patients with type 1 diabetes (REMOVAL): a double-blind, randomised, placebo-controlled trial. , 2017, The lancet. Diabetes & endocrinology.

[19]  A. Bhargava,et al.  Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial , 2017, JAMA.

[20]  P. Yu,et al.  Effects of Insulin Plus Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RAs) in Treating Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis , 2017, Diabetes Therapy.

[21]  B. Zinman,et al.  Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes , 2017, The New England journal of medicine.

[22]  S. Heller,et al.  Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1) , 2017, Diabetes Care.

[23]  D. Giugliano,et al.  Insulin and Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Type 2 Diabetes: A Systematic Review and Meta-analysis of Randomized Controlled Trials , 2017, Diabetes Care.

[24]  Benyamin Grosman,et al.  Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes , 2017, Diabetes technology & therapeutics.

[25]  M. Kahle,et al.  A meta‐analysis comparing clinical effects of short‐ or long‐acting GLP‐1 receptor agonists versus insulin treatment from head‐to‐head studies in type 2 diabetic patients , 2017, Diabetes, obesity & metabolism.

[26]  D. Owens,et al.  Patient-level meta-analysis of efficacy and hypoglycaemia in people with type 2 diabetes initiating insulin glargine 100U/mL or neutral protamine Hagedorn insulin analysed according to concomitant oral antidiabetes therapy. , 2017, Diabetes research and clinical practice.

[27]  Bruce W Bode,et al.  Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. , 2016, JAMA.

[28]  I. Hirsch,et al.  New Insulin Delivery Recommendations. , 2016, Mayo Clinic proceedings.

[29]  W. Cefalu,et al.  Clinical Considerations for Use of Initial Combination Therapy in Type 2 Diabetes , 2016, Diabetes Care.

[30]  J. Lachin,et al.  Mortality in Type 1 Diabetes in the DCCT/EDIC Versus the General Population , 2016, Diabetes Care.

[31]  S. Hutfless,et al.  Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes , 2016, Annals of Internal Medicine.

[32]  G. Bray,et al.  Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Prevention Program Outcomes Study. , 2016, The Journal of clinical endocrinology and metabolism.

[33]  M. Matsuhisa,et al.  New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1) , 2016, Diabetes, obesity & metabolism.

[34]  T. Morwick,et al.  EFFECT OF TOTAL DAILY DOSE ON EFFICACY, DOSING, AND SAFETY OF 2 DOSE TITRATION REGIMENS OF HUMAN REGULAR U500 INSULIN IN SEVERELY INSULIN-RESISTANT PATIENTS WITH TYPE 2 DIABETES. , 2016, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[35]  R. Bergenstal,et al.  Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12‐month trial including 6‐month extension , 2015, Diabetes, obesity & metabolism.

[36]  J. McGill,et al.  Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial , 2015, Diabetes Care.

[37]  R. Bergenstal,et al.  New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 1 Diabetes: A Randomized, Phase 3a, Open-Label Clinical Trial (EDITION 4) , 2015, Diabetes Care.

[38]  B. Wayne Bequette,et al.  Predictive Low-Glucose Insulin Suspension Reduces Duration of Nocturnal Hypoglycemia in Children Without Increasing Ketosis , 2015, Diabetes Care.

[39]  G. Steil,et al.  Impact of Fat, Protein, and Glycemic Index on Postprandial Glucose Control in Type 1 Diabetes: Implications for Intensive Diabetes Management in the Continuous Glucose Monitoring Era , 2015, Diabetes Care.

[40]  M. Riddle,et al.  One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension , 2015, Diabetes, obesity & metabolism.

[41]  R. DeFronzo,et al.  Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add‐on therapy in subjects with new‐onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT): a randomized trial , 2015, Diabetes, obesity & metabolism.

[42]  R. Bergenstal,et al.  Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes. , 2015, Mayo Clinic proceedings.

[43]  R. Bergenstal,et al.  New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3) , 2015, Diabetes, obesity and metabolism.

[44]  Hyoil Han,et al.  Severe hypoglycemia and coronary artery calcification during the diabetes control and complications trial/epidemiology of diabetes interventions and complications (DCCT/EDIC) study. , 2015, Diabetes research and clinical practice.

[45]  B. Zinman,et al.  Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis , 2014, The Lancet.

[46]  P. Lucidi,et al.  Pharmacokinetics and Pharmacodynamics of Insulin Glargine Given in the Evening as Compared With in the Morning in Type 2 Diabetes , 2014, Diabetes Care.

[47]  R. Bergenstal,et al.  New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Oral Agents and Basal Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION 2) , 2014, Diabetes Care.

[48]  Catherine H. Yu,et al.  Safety, effectiveness, and cost effectiveness of long acting versus intermediate acting insulin for patients with type 1 diabetes: systematic review and network meta-analysis , 2014, BMJ : British Medical Journal.

[49]  B. Hoogwerf,et al.  Glucagon-Like Peptide 1 Receptor Agonist or Bolus Insulin With Optimized Basal Insulin in Type 2 Diabetes , 2014, Diabetes Care.

[50]  R. Hayward,et al.  Effect of patients' risks and preferences on health gains with plasma glucose level lowering in type 2 diabetes mellitus. , 2014, JAMA internal medicine.

[51]  M. S. Kirkman,et al.  Type 1 Diabetes Through the Life Span: A Position Statement of the American Diabetes Association , 2014, Diabetes Care.

[52]  S. Engel,et al.  Early combination therapy for the treatment of type 2 diabetes mellitus: systematic review and meta‐analysis , 2014, Diabetes, obesity and metabolism.

[53]  S. Colagiuri,et al.  Efficacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis. , 2014, The lancet. Diabetes & endocrinology.

[54]  H. Rodbard,et al.  Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. , 2014, The lancet. Diabetes & endocrinology.

[55]  J. Pickup The Evidence Base for Diabetes Technology: Appropriate and Inappropriate Meta-Analysis , 2013, Journal of diabetes science and technology.

[56]  B. Zinman,et al.  Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial , 2013, Diabetic medicine : a journal of the British Diabetic Association.

[57]  D. Klonoff,et al.  Threshold-based insulin-pump interruption for reduction of hypoglycemia. , 2013, The New England journal of medicine.

[58]  S. Heller,et al.  Meta-analysis of insulin aspart versus regular human insulin used in a basal–bolus regimen for the treatment of diabetes mellitus , 2013, Journal of diabetes.

[59]  R. Henry,et al.  Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial , 2012, International journal of clinical practice.

[60]  A. McCall Insulin therapy and hypoglycemia. , 2012, Endocrinology and metabolism clinics of North America.

[61]  B. Zinman,et al.  A 1-year, randomized, treat-to-target trial (BEGIN Once Long) , 2012 .

[62]  Nisa M. Maruthur,et al.  Comparative Effectiveness and Safety of Medications for Type 2 Diabetes: An Update Including New Drugs and 2-Drug Combinations , 2011, Annals of Internal Medicine.

[63]  S. Davis,et al.  Dose-Response Effects of Insulin Glargine in Type 2 Diabetes , 2010, Diabetes Care.

[64]  R. Roberts,et al.  Safe and simple emergency department discharge therapy for patients with type 2 diabetes mellitus and severe hyperglycemia. , 2009, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[65]  P. Raskin,et al.  Patient‐directed titration for achieving glycaemic goals using a once‐daily basal insulin analogue: an assessment of two different fasting plasma glucose targets ‐ the TITRATETM study , 2009, Diabetes, obesity & metabolism.

[66]  N. Marchionni,et al.  Short‐acting insulin analogues vs. regular human insulin in type 2 diabetes: a meta‐analysis , 2009, Diabetes, obesity & metabolism.

[67]  R. Holman,et al.  10-year follow-up of intensive glucose control in type 2 diabetes. , 2008, The New England journal of medicine.

[68]  N. Marchionni,et al.  Long-acting insulin analogues versus NPH human insulin in type 2 diabetes: a meta-analysis. , 2008, Diabetes research and clinical practice.

[69]  M. Fisher,et al.  Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) , 2007 .

[70]  L. Kennedy A 26-Week, Randomized, Parallel, Treat-to-Target Trial Comparing Insulin Detemir With NPH Insulin as Add-On Therapy to Oral Glucose-Lowering Drugs in Insulin-Naïve People With Type 2 Diabetes , 2007 .

[71]  David M Nathan,et al.  The Effect of Intensive Glycemic Treatment on Coronary Artery Calcification in Type 1 Diabetic Participants of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study , 2006, Diabetes.

[72]  H. Yki-Järvinen,et al.  Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study , 2006, Diabetologia.

[73]  O G Kolterman,et al.  Amylin replacement with pramlintide as an adjunct to insulin therapy improves long‐term glycaemic and weight control in Type 1 diabetes mellitus: a 1‐year, randomized controlled trial , 2004, Diabetic medicine : a journal of the British Diabetic Association.

[74]  J. Rosenstock,et al.  The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. , 2003, Diabetes care.

[75]  I. Hirsch,et al.  Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. , 2003, JAMA.

[76]  M. Baran Pancreas transplantation. , 1982, The Diabetes educator.