Dexcom’s G5 Mobile CGM Recommended to FDA for Non-Adjunct Therapy

The Clinical Chemistry and Clinical Toxicity Devices Panel recommended to the FDA today that in addition to tracking and trending blood glucose concentration, patients should be able to use the Dexcom G5 Mobile continuous glucose monitor (CGM) device as a replacement for blood glucose meters and to make treatment decisions based on readings from the CGM. The panel, an FDA advisory committee, voted 8-2 that the benefits of using the system for the proposed non-adjunctive indication outweigh risks. The panel also voted in favor of the indication being safe and effective.

Supporting evidence for this recommendation included computer modeling, clinical accuracy study data, human factors studies, and experience with the device being on the market.

NOVO developed an award-winning disposable applicator and pod for Dexcom and has provided product development support over many years.