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Dexcom is set to launch its first over-the-counter continuous glucose monitor, Stelo, in late August. This summer will see the release of the first OTC glucose sensors in the U.S., following FDA clearance for Dexcom and Abbott in March and June, respectively. These new devices use the same hardware as previous CGMs but are designed for a different user base: people who do not use insulin.
Dexcom's Stelo device targets individuals with Type 2 diabetes who do not take insulin but can also be used by non-diabetics, according to FDA's broad labeling. Abbott plans to divide its OTC products into two sensors: Lingo, for non-diabetics, and Libre Rio, aimed at Type 2, non-insulin users, directly competing with Dexcom.
These new devices could potentially reach about 25 million people in the U.S. with Type 2 diabetes who don’t use insulin, 15 million diagnosed with pre-diabetes, and approximately 85 million with undiagnosed pre-diabetes.
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