Updates include new treatment information for people with type 2 diabetes and diabetes-related chronic kidney disease.

On June 5, the American Diabetes Association^® (ADA) issued important updates to the 2019 Standards of Medical Care in Diabetes (Standards of Care), in annotations as the Living Standards of Care, focused on improving cardiovascular and renal health in people with type 2 diabetes. The updates were informed by newly published research and crafted and approved by the ADA’s Professional Practice Committee (PPC), which is responsible for producing the annual Standards of Care. Updates to Section 10, Cardiovascular Disease and Risk Management, have also been reviewed and approved by the American College of Cardiology, who also endorse this section. The Living Standards of Care are available immediately online at Diabetes Care.

Sections 10 and 11 were updated based on findings from the Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy (CREDENCE) trial, published April 14, 2019, in the New England Journal of Medicine, which assessed the impact of canagliflozin therapy on cardiorenal outcomes in patients with diabetes-related chronic kidney disease. CREDENCE found that use of canagliflozin by patients with type 2 diabetes and chronic, diabetes-related kidney disease lowered the risk of the primary composite outcome (inclusive of end-stage kidney disease, doubling of serum creatinine, or death from renal or cardiovascular diseases) by 30%. The relative risk of the renal-specific composite, which included end-stage kidney disease, a doubling of the creatinine level, or death from renal causes, was 34% lower in the group receiving canagliflozin. The relative risk of end-stage kidney disease was lower by 32%.

Canagliflozin was additionally found to have a lower risk for the composite of cardiovascular death, myocardial infarction, or stroke, as well as lower risk of hospitalization for heart failure, and for the composite of cardiovascular death or hospitalization for heart failure. In terms of safety, no significant increase in lower-limb amputations, fractures, acute kidney injury or hyperkalemia were noted for canagliflozin relative to placebo in CREDENCE. An increased risk for diabetic ketoacidosis (DKA) was noted, however, with canagliflozin.

“The CREDENCE trial was the first sodium-glucose cotransporter 2 (SGLT2) inhibitor trial to assess renal-specific primary outcomes and ended early due to efficacy. Incorporating these findings into the Standards of Care now gives providers the latest evidence-based recommendations to treat people with type 2 diabetes and diabetes-related chronic kidney disease. Our Mission at the ADA is to improve the lives of all those with diabetes and providing timely updates to our Standards of Care can help achieve that goal. Improving care for the millions of Americans living with diabetes cannot wait,” said the ADA’s chief scientific, medical and mission officer William T. Cefalu, MD.

The Standards of Care provide the latest in comprehensive, evidence-based recommendations for the diagnosis and treatment of children and adults with type 1, type 2, or gestational diabetes; strategies to improve the prevention or delay of type 2 diabetes; and therapeutic approaches that reduce complications and positively affect health outcomes. Beginning in 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, with annotations for new evidence or regulatory changes that merit immediate incorporation. The online version of the Standards of Care will include any research updates or policy changes that are approved throughout 2019.

Updates to the Standards of Care are established and revised by the ADA’s PPC. The committee is a multidisciplinary team of 14 leading US experts in the field of diabetes care and includes physicians, diabetes educators, registered dietitians, and others whose experience includes adult and pediatric endocrinology, epidemiology, public health, lipid research, hypertension, preconception planning, and pregnancy care. For the 2019 Standards of Care, two designated representatives from the American College of Cardiology (ACC) reviewed, provided feedback, and endorsed the recommendations for cardiovascular disease and risk management on behalf of the ACC. The ACC designated representatives also reviewed and approved the updates made to the cardiovascular disease and risk management section. The PPC performs an extensive, global clinical diabetes literature search each year for the annual Standards of Care update, supplemented with input from ADA leaders and staff and the medical community at large. Members of the PPC must disclose potential conflicts of interest with industry and/or relevant organizations; these disclosures are available on page S184 of the 2019 Standards of Care.

The complete, annotated Standards of Care, which includes updates made today, can be accessed online on Diabetes Care. The Abridged Standards of Medical Care in Diabetes have also been updated and can be accessed online on Clinical Diabetes.