William T. Cefalu
The American Diabetes Association recently issued two updates to its 2018 Standards of Medical Care in Diabetes, reflecting a recent December consensus report that revised the definition of hypoglycemia and the FDA approval of two new antidiabetes drugs.
The revisions, available in the online version of the Standards of Care, are part of a new effort from the ADA to revise the guide throughout the year, rather than annually, as new evidence or regulatory changes merit immediate incorporation.
“With the rapid pace that information becomes available, releasing new recommendations on an annual basis is no longer sufficient,” William T. Cefalu, MD, chief scientific, medical and mission officer for the ADA, said in a press release announcing the change. “Now that the Standards of Care will be updated throughout the year, clinicians, patients, researchers, payers and others interested in diabetes care will have the latest information at their fingertips whenever they need it. Ensuring timely availability and access to this information is critical to improving patient care and outcomes.”
In December, stakeholders in the type 1 diabetes community issued a consensus report recommending the use of standardized definitions for several diabetes outcome measurements beyond HbA1c, including standard definitions for hypoglycemia. The report, produced by the Type 1 Diabetes Outcomes Program, defined three levels of hypoglycemia:
level 1, defined as a measurable glucose concentration of less than 70 mg/dL but greater than 54 mg/dL;
level 2, defined as a glucose measurement of less than 54 mg/dL; and
level 3, defined as a “severe event characterized by altered mental and/or physical status requiring assistance.”
The researchers noted these new definitions are “slight modifications” to the recently published ADA and European Association for the Study of Diabetes joint position statement on hypoglycemia. These new recommendations are considered an update to that joint statement, they wrote.
of semaglutide, ertugliflozin
Also in December, the FDA approved new drug applications for the GLP-1 receptor agonist semaglutide (Ozempic, Novo Nordisk) and three new medicines containing the SGLT2 inhibitor ertugliflozin for the treatment of type 2 diabetes in adults. The once-weekly semaglutide injection, available in 0.5-mg and 1-mg formulations in a prefilled pen, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Other approvals included oral ertugliflozin (Steglatro, Merck) and the fixed-dose combinations ertugliflozin/sitagliptin (Steglujan, Merck) and ertugliflozin/metformin (Segluromet, Merck). The three formulations will be made available in early 2018, according to Merck and Pfizer.
The medications were added to “Section 8: Pharmacologic Approaches to Glycemic Treatment” in the Standards of Care.
The Standards of Care is revised annually by the ADA’s Professional Practice Committee. The most recent edition was published in December in Diabetes Care. – by Regina Schaffer
ADA. Standards of Medical Care in Diabetes – 2018. Available at: care.diabetesjournals.org/content/41/Supplement_1.