The US Food and Drug Administration (FDA) has cleared Dexcom’s Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitoring (CGM) system.
Unlike other Dexcom systems, the Stelo is intended for adults with or without diabetes who do not use insulin. It comprises a wearable sensor paired with an application installed on a smartphone or other reader device. It continuously measures, records, analyzes, and displays glucose values every 15 minutes. Each sensor can be worn for up to 15 days before it must be replaced.
It is not intended to be used to make medical decisions without first checking with a healthcare provider. It is also not for individuals with problematic hypoglycemia, as it does not alert the user to this potentially dangerous condition.
Stelo will be available in the USA without a prescription from the summer of 2024.
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