May 21, 2018
Diabetes Care has published a groundbreaking article that could change the way the health of diabetes patients is measured and evaluated. This new evaluation seeks to broaden our understanding of diabetes management, from a single glycemic data point to a more comprehensive assessment of living with diabetes.
Click here to read the article.
The article, “Need for Regulatory Change to Incorporate Beyond A1C Glycemic Metrics” by The Beyond A1C Writing Group, was just published in the June issue of Diabetes Care.
Led by The diaTribe Foundation, the Beyond A1C Writing Group highlighted consensus on glycemic measurements for research purposes and the need to incorporate outcomes beyond A1C into regulatory decisions and clinical care.
The article synthesizes the results of a consensus meeting held in July, 2017 titled “Glycemic Outcomes Beyond A1C: Standardization and Implementation.” The diaTribe Foundation convened leaders from American Association of Clinical Endocrinologists (AACE), American Diabetes Association (ADA), Advanced Technologies & Treatments for Diabetes (ATTD), European Association for the Study of Diabetes (EASD), European Medicines Agency (EMA), Endocrine Society, U.S. Food and Drug Association (FDA), International Hypoglycaemia Study Group (IHSG), and JDRF, as well as industry, academic institutions, and patient groups, to participate in the groundbreaking meeting.
Regulatory and clinical evaluation rely heavily, if not solely, on A1C in measuring diabetes outcomes. The limitations of A1C demonstrate a significant need to incorporate outcomes that better reflect daily glycemic fluctuations and quality of life. In response to these limitations, the diabetes community has developed consensus on key glycemic metrics to be used in research, therapy development, and regulatory review.
As Dr. William Cefalu, Chief Scientific, Medical, and Mission Officer of the ADA, said at the consensus meeting in July 2017, “We all understand that A1C means many things for many different people. If you could eliminate hypoglycemia and improve quality of life, that’s where we’re going and that’s why everyone is here today. The question is how to implement this for regulatory bodies and the clinic.”