OSP News

The First FDA Cleared Over-the-Counter Continuous Glucose Monitor Available

Posted: 08/26/2024

In March 2024, the FDA cleared for marketing the Dexcom Stelo Glucose Biosensor System and it is now available for purchase. The device is the first over-the-counter (OTC) continuous glucose monitor (CGM) available without a prescription. Clearance was based on data from a clinical study that showed the device performed similarly to other integrated CGMs. 

Stelo is an integrated CGM intended for people ≥ 18 years old who do not use insulin. The system consists of a wearable sensor that is paired with an app installed on a smartphone or other smart device. It continuously measures, records, and analyzes glucose levels.

Each sensor lasts 15 days and when worn will present blood glucose levels and trends every 15 minutes in the app. Users should not make medical decisions based on the device’s results without talking to a healthcare provider. This system is not recommended for individuals with problematic hypoglycemia as the system is not designed to alert the user of this potentially dangerous condition.

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