First Over-the-Counter Glucose Monitor

Dexcom has announced the clearance of its new over-the-counter continuous glucose monitor, Stelo, by the U.S. Food and Drug Administration. Stelo, which underwent FDA review in February, will be worn on the upper arm and has a lifespan of up to 15 days before replacement. This device will be available for online purchase starting this summer.

Continuous glucose monitors (CGMs) are small sensors that penetrate the skin to monitor glucose levels in real-time, primarily used by diabetes patients. Information from the sensor is transmitted wirelessly to a smartphone, aiding in the detection of emergencies for users, their families, and healthcare providers.

Stelo, Dexcom’s latest CGM, is specifically designed for Type 2 diabetes patients who do not require insulin. Notably, it is the first glucose biosensor that does not mandate a prescription, expanding accessibility, particularly for those without insurance coverage for CGMs.

With over 25 million Type 2 diabetes patients in the U.S. who do not use insulin, Dexcom aims to bridge the gap in accessibility. While their existing G7 CGM system serves this population, it necessitates a prescription, limiting its availability.

The FDA’s clearance reflects the significance of CGMs in managing blood glucose levels. Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, highlighted how this clearance facilitates individual access to CGMs without healthcare provider involvement.

Leave a Reply

Your email address will not be published. Required fields are marked *