FDA Clears First OTC Continuous Glucose Monitor

Dexcom’s Stelo Glucose Biosensor system has received the first FDA marketing clearance for an OTC continuous glucose monitor (CGM).

The system is an integrated CGM (iCGM) for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. The system is not for individuals with low blood sugar, as it is not designed to alert the user to this potentially dangerous condition.

Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. Adverse events reported in the study included local infection, skin irritation and pain or discomfort.

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