FDA to Ask: What Outcomes Matter Besides A1C?

The FDA is working with several leading diabetes advocacy and professional groups to organize an August 29, 2016, workshop: Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c). Kelly Close, founder of diaTribe.org and president of Close Concerns, wrote in a blog post that The diaTribe Foundation was among several groups approached by FDA to help make the workshop happen; others included JDRF, the American Diabetes Association, the American Association of Clinical Endocrinologists.

The purpose of the meeting, according to an FDA statement is “to have a forum for dialogue with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes, and to address additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease.”

According to Close’s post, other outcomes that might be considered are time in range, occurrences of hypoglycemia, glucose variability, weight change, and diabetes burden. “That last one is especially important, I think—it’s something the Surgeon General has been talking about a lot lately. He calls it ‘emotional well-being—this contributes so much to lows and highs that can be ‘drowned out’ by A1C.”

The meeting will take place at FDA’s White Oak campus, 10903 New Hampshire Ave, in Silver Spring, Maryland. Early registration is recommended due to limited seating. For registration information, click here. This link also allow registration for a webcast for those who wish to attend remotely.

Close suggests that those who want to share their stories with the FDA submit a video clip, discussing what they struggle with in their diabetes and what they would want a new diabetes to help with beyond A1C. Videos should be sent to HCM Strategies at videos@hcmstrategies.com and shared on social media using the hashtag #DOCasksFDA.