FDA Hosts the First Live Patient Chat on Diabetes and Glucose Monitoring Devices; How You Can Influence FDA Guidelines

In a live online chat on March 31, highly-regarded FDA Director Dr. Courtney Lias and patient advocate Bennet Dunlap, founder of Strip Safely discussed the new blood glucose monitoring draft guidelines. These proposed standards will raise the bar on glucose meter accuracy, among many other changes (learn more about the draft guidelines here). What was so notable about this event was the willingness of the FDA to sit down and chat very candidly with Mr. Dunlap. Dr. Lias’ appearance also continues a recent Agency trend of open dialogue at more public events, a move that is very encouraging from a patient perspective. Please click here to view a recording of the live chat and here to follow the conversation #DOCasksFDA on Twitter. Dr. Lias ended the session by encouraging everyone impacted by diabetes to comment on the draft guidance for self-monitoring blood glucose test systems. The open period for public comment here has been extended until May 7, and we urge everyone who has not yet commented to make their voices heard. You can learn more here about the draft guidelines here and what they mean for you. We did have several unanswered questions following the session, and wish we had been called upon! Specifically, we’re interested in learning why companies can submit for approval using self-reported data, how the surveillance initiative for blood glucose monitoring is looking, and how hospital glucose monitoring will fare going forward. –NL/KC