Memorandum

diaTribe Foundation-organized consensus conference on glycemic outcomes beyond A1C to take place on July 21st in Bethesda, MD - June 20, 2017

On Friday July 21st (one month from now!) leaders in the diabetes community will gather in the FDA’s backyard to discuss steps toward widespread implementation of several agreed-upon glycemic outcomes metrics, as well as to explore how patients and providers view and talk about glycemia. Drs. Janet Woodcock (!), Bruce Buckingham, Phillip Home, Rick Bergenstal, Robert Ratner, and Aaron Kowalski are just some of the influential figures who will be in attendance. The meeting builds off a recent packed ADA symposium, chaired by Dr. Buckingham and Ms. Close, during which Drs. Bergenstal, Thomas Danne, George Grunberger, Anne Peters, Simon Heller, and Kowalski highlighted the progress that has been made toward reaching consensus. Although Dr. Buckingham concluded the session by claiming that we “were all in the room where [consensus] happened,” it is now critical to discuss the related terminology and implementation strategies with a wide range of stakeholders. This consensus conference, therefore, will (i) call upon experts to identify where there is consensus and where work still needs to be done; (ii) explore the impact of this research for patients and providers; and (iii) invite participants to engage in facilitated discussions on glycemic variability, terminology, education, and implementation. By bringing together various diabetes organizations, including AACE, ADA, ATTD, EASD, EMA, Endocrine Society, IHSG, and JDRF, we hope to demonstrate to the FDA that A1c may be necessary, but is no longer sufficient. The event will take place at the Bethesda North Marriott Hotel and Conference Center from 8 AM-5 PM, and is sure to be both instructive and productive. We would absolutely love for you to join us at this influential event! Registration is very limited (and free!), so sign up here.

  • Last August, FDA hosted a public workshop entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c.” The conference was well-attended, with over 900 in-person and online participants. Speakers emphasized that, while A1c levels remain a critical tool in assessing diabetes treatment success, other measurements – time in ranges, hypoglycemia, patient-reported outcomes – must be considered to truly maximize quality of life for people with diabetes and the impact of therapies. Way back in November 2014, diaTribe helped facilitate formal conversations between patient advocates in the diabetes community and FDA with the “FDA-Patient Dialogue on Unmet Needs in Diabetes” event. Adam and Kelly played pivotal roles in the at-the-time unprecedented meeting, which helped paved the way for diaTribe to organize the community to continue to make progress on these important issues!

-- by Maeve Serino, Brian Levine, and Kelly Close