First Over-the-Counter Glucose Monitor Gets Clearance From the FDA

The U.S. Food and Drug Administration (FDA) has granted marketing clearance to the first over-the-counter continuous glucose monitor (CGM), the Dexcom Stelo Glucose Biosensor System. This innovative, integrated CGM (iCGM) system is intended for use by adults with diabetes who are not on insulin or adults without diabetes who want to understand how their lifestyle choices can affect blood sugar levels. The system is not suitable for individuals prone to serious hypoglycemia as it doesn’t alert users to this potentially dangerous condition. 

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The device utilizes a wearable sensor which, paired with an app installed on a smart device, continuously measures, records, and analyzes glucose levels. Each sensor is wearable for up to 15 days before requiring replacement. Blood glucose measurements and trends are displayed in intervals of 15 minutes in the app.  

However, users should not base medical decisions solely on the app’s information without consulting their healthcare provider. Clinical data supplied to the FDA demonstrated that the Stelo Glucose Biosensor System performs comparably to other iCGMs.  

Director of the FDA’s Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D., remarked that the clearance broadens access to important health information, a significant step toward health equity for U.S. patients.