FDA Approves First OTC Continuous Glucose Monitor

The FDA has approved Dexcom’s Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitoring system for adults with or without diabetes who do not use insulin. The system, which consists of a wearable sensor and a smartphone application, continuously measures and displays glucose values every 15 minutes. It is not intended for individuals with problematic hypoglycemia and should not be used to make medical decisions without consulting a healthcare provider. The device performed similarly to other integrated CGMs with low adverse event rates. This clearance will expand access to CGMs by allowing individuals to purchase them without a prescription, promoting health equity for US patients.

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