The FDA has cleared its first over-the-counter wearable blood sugar tracker, with Dexcom’s slimmed-down Stelo continuous glucose monitor.
The agency’s green light allows adults 18 years and older who are not taking any insulin therapies to purchase the system without a prescription—a group that includes about 25 million people living with Type 2 diabetes in the U.S., according to the company, as well as people without diabetes who may want to better understand the effects of diet and exercise.
Unveiled earlier this year, Dexcom has pitched the Stelo as a more “health-focused” version of its top-of-the-line CGM, the G7, which made its debut early last year. Though built on the same sensor platform, the Stelo will operate without the low blood sugar alerts or software features needed by people with Type 1 diabetes, who use real-time glucose data to carefully calculate their daily doses of insulin.
