The American Diabetes Association (ADA) recently updated its 2021 Standards of Medical Care in Diabetes.
Beginning with the 2018 edition, the Standards of Care has become a living document that is updated as needed by the ADA's Professional Practice Committee. On June 16, the ADA announced the following changes to its recommendations, which were driven by recently published research and are available online at Diabetes Care as annotations to the document:
- Section 2, Classification and Diagnosis of Diabetes, was revised to include the evidence from a trial on an anti-CD3 antibody, teplizumab, in relatives of people with type 1 diabetes. Delay of overt diabetes development in at-risk relatives was reported with the drug in 2019, with an extension of the trial reported in 2021. Based on these data, the drug was submitted to the FDA for the indication of delay or prevention of clinical type 1 diabetes in at-risk individuals. Neither this agent nor others in this category are currently available for clinical use. In a revised B-grade statement, the ADA recommended screening for type 1 diabetes risk with a glutamic acid decarboxylase autoantibody in the setting of a research trial or as an option for first-degree family members of a proband with type 1 diabetes.
- Section 10, Cardiovascular Disease and Risk Management, was annotated to include evidence from trials of sodium-glucose cotransporter-2 inhibitors, including the Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial (VERTIS CV), Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED), Empagliflozin Outcome Trial in Patients with Chronic Heart Failure and a Reduced Ejection Fraction (EMPEROR-Reduced), and Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF). The additional annotations did not change the existing recommendation for the use of sodium-glucose cotransporter-2 inhibitors in patients with type 2 diabetes and established heart failure with reduced ejection fraction. These updates were reviewed and approved by the American College of Cardiology, which endorses this section.
- Section 11, Microvascular Complications and Foot Care, was amended to include new evidence from two trials of medications that impact patients with chronic kidney disease, the Dapagliflozin in Patients with Chronic Kidney Disease (DAPA-CKD) study and the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) trial. In 2020, the former trial found that compared with placebo, dapagliflozin had a 0.56 hazard ratio (95% CI, 0.45 to 0.68; P<0.001) for the primary outcome of at least 50% sustained decline in estimated glomerular filtration rate or end-stage renal disease or death from cardiovascular or renal causes. Also in 2020, the latter trial found that finerenone, a novel nonsteroidal mineralocorticoid receptor antagonist, demonstrated a significant reduction in chronic kidney disease progression and cardiovascular events in patients with advanced diabetic kidney disease.