An FDA advisory panel has voted in favor of recommending a change to the intended use of Dexcom’s G5 Continuous Glucose Monitor (CGM). The G5 had already been FDA-approved, but with limitations as an adjunctive device, meaning it could only be used for tracking and trending interstitial fluid gluocose concentrations rather than as a full replacement for a traditional fingerstick blood glucose meter (BGM).
[Correction: An earlier version of this article stated that the advisory panel's vote meant that Dexcom could now market the G5 as a replacement for fingerstick tests, but the panel's vote is a recommendation to the agency, not a decision or clearance in and of itself.]
If the agency follows the panel's recommendation, the San Diego, California-based Dexcom will be able to market the G5 as a CGM patients can actually base treatment decisions on rather than a complement to the BGM. To support the potential use of the G5 under the new labeling, Dexcom provided clinical data from trials of its G4 CGM (which uses an identical glucose sensor and the same algorithms) prior to the FDA meeting.
During a closely-watched public advisory committee meeting yesterday, the Clinical Chemistry and Clinical Toxicology Devices Panel of the FDA voted that the G5 is safe and effective and that its benefits outweigh the risks.
“This recommendation is a big milestone for people with diabetes,” Kevin Sayer, Dexcom President and CEO said in a statement. “The diabetes community turned out in force to support this decision…we look forward to continued positive discussions with the FDA as we seek the agency’s approval of our application.”
Among the many constituents of the diabetes community who attended the meeting was patient advocacy group DiaTribe Foundation, which sent a letter to the FDA and also shared live video on Facebook during the meeting.
Earlier this week, the FDA released information for the panel that expressed reservations that the accuracy of the G5 was not as good as traditional BGMs, but also said the device offered contextual information and self-monitoring that BMGs don’t provide, which could in turn help users make more informed insulin dosing decisions.
Unlike the company’s previous CGM devices, the G5 Mobile CGM System has Bluetooth built right into the transmitter, sending glucose data directly to a smartphone and eliminating the need for users to carry a separate receiver device. Data from the CGM can be sent to iOS devices, including the Apple Watch.