On August 29, the FDA will host a public workshop on diabetes outcomes beyond A1c, a momentous event that the FDA asked The diatribe Foundation to work on last year, in partnership with the JDRF, the American Diabetes Association, the American Association of Clinical Endocrinologists, and Anna McCollister-Slipp/Scripps. The workshop will identify and discuss meaningful diabetes outcomes beyond A1c to help inform future FDA regulation of diabetes drugs and devices and we’re so eager to include as many patient and community voices as possible!.

This workshop follows the landmark November 2014 FDA event that brought forth thousands of patient and expert opinions (you might recall the servers failed due to the volume of patients calling in!) on challenges that people with diabetes face every day, the improved therapies and technologies they’d like to see, and what FDA reviewers should keep in mind as they consider new drugs and devices. The meeting emphasized the need to move beyond static A1c numbers, which are a valuable piece of our collective puzzles but do not adequately measure the volatility of blood sugar movements and the overall complexity of the disease so many of us share.  As all of the patient advocates expressed at the meeting, A1c simply does not tell the full story of a patient’s experience – you might remember Dr. Aaron Kowalski and advocate Angie Platt’s eloquent words on this in particular.

As someone who has lived with diabetes for nearly 30 years, I can personally testify to the many factors and measures that truly determine my own health and well-being – all of which cannot be captured by a single number. At the upcoming workshop on August 29, we will encourage the FDA to consider additional outcomes, such as time in range, 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.   Our goal is to ensure a more holistic judgment of a therapy’s effectiveness that includes A1c and is supplemented by other measures as well.

Today, I ask for your input and support in making the workshop a success. As a community of people touched by diabetes, we have a huge opportunity to present the numerous challenges we face each day, and we need as many opinions as possible. There are three major ways for you to get involved in the event:

1. Register to attend live or remotely. We invite you to register to attend in person or via webcast – both are completely free and open to the public.
2. Submit a short video clip. To prepare for the event, the great policy firm HCM is compiling a video for FDA members and other workshop attendees.  Thank you so much to them! We want to bring as many patient voices as possible to the FDA, so the more submissions we can share in our video, the stronger our message will be! You can share your perspective on outcomes beyond A1c by submitting a short video clip (~10 seconds) from your phone or computer answering one (or both) of the following questions:

What I struggle most with in managing my diabetes is _________.

Beyond helping me with A1c, I wish a new diabetes drug would _________.

Once you finish, you can send your clip to [email protected], and share on social media using the hashtag #DOCasksFDA.

Submit written comments. In addition to submitting your video, if you have additional thoughts on outcomes beyond A1c, please send us your thoughts here! The FDA will receive a collection of comments from patients that will be organized by us similar to November 2014. Additionally, there will be a dQ&A survey landing in mailboxes soon - if you’re on the dQ&A panel already, watch out for that survey in your email box! This is part of a longer effort so if you are not part of the panel yet, and would like to be, let us know and we'll get the information to you! 

I am most excited about the videos, which will be so successful with a wide range of perspectives and experiences. We encourage those of all ages with type 1 and type 2 as well as gestational diabetes to share your story and help make a difference. We cannot wait to share the end product so please consider and take two minutes to tell the FDA about your diabetes expereinces. 

Thank you for inspiring us, supporting us, and helping us to advocate for change.

very best,

kelly