FDA looks #BeyondA1C

When I was at the recent #AADE16 meeting, I heard and read a lot about looking at outcomes other than A1C. This was the first time I actually heard someone mention “patient-driven outcomes.” Thinking about things that matter to people with diabetes – what a concept! Things like quality of life, hypoglycemia, and time in target (blood glucose range) I can get behind.

On August 29th the FDA is holding a day-long workshop where they will listen to public comment on what matters to people with diabetes. What kinds of outcomes do we want them to look at in order to develop drugs/technology that would be helpful to us?

From the workshop description:

The ultimate purpose of identifying and qualifying these outcomes for regulatory purposes would be to continue to support the development of novel therapies that directly address the needs of diabetes patients living with the disease. There will be an opportunity for questions and answers following each presentation.

And here is the complete info on the workshop – you can join virtually if you won’t be in Maryland next Monday. Sign up by August 26th. And diaTribe is asking us to submit videos with our ideas for outcomes beyond A1C.

Here’s mine. As a diabetes professional, I believe that developing or perfecting diabetes drugs that could limit or eradicate hypoglycemia would be incredibly beneficial. Many people purposely run high – and risk complications – because they fear hypoglycemia. I have met people with post-traumatic stress disorder (PTSD) related to severe hypoglycemia events that occurred during childhood. Additionally, signs and symptoms of hypoglycemia change over time, and risk of severe lows and hypoglycemia unawareness increases. Personally, I find hypoglycemia incredibly annoying. It interferes with my ability to get things done or to sleep through the night. It’s frustrating and a waste of time.

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