Leading Diabetes Groups Publish Consensus Statement on "Beyond A1C" Measures to Guide FDA, Researchers
The Beyond A1C movement seeks regulatory and clinical are frameworks that recognize the day-to-day measures that matter to patients, such as how often they experience hypoglycemia.
After 2 years of work, a consortium of leading diabetes groups published a statement Tuesday that they hope will guide the FDA when it evaluates how drugs and devices affect the everyday health of people with type 1 diabetes (T1D).
The statement, appearing in the journal Diabetes Care, defines stages of hypoglycemia, hyperglycemia, time in range, and diabetic ketoacidosisis (DKA). It is a milestone in the “Beyond A1C” movement, an effort by diabetes clinicians and advocates to get regulators—and payers—to recognize management tools based on criteria other than their ability to control glycated hemoglobin (A1C).
Organized by JDRF, the Steering Committee for the Type 1 Diabetes Outcomes Program issued the statement, “Standardizing Clinically Meaningful Outcome Measures Beyond HbA1C for Type 1 Diabetes.” The committee includes members of the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists (AACE), the American Association of Diabetes Educators, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and T1D Exchange.
The statement acknowledges what people living with T1D tell clinicians and researchers—while A1C is a useful measure, it fails to capture the day-to-day experience of living with a disease that some describe as a blood sugar roller coaster. JDRF said in a stat Continue reading