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.
“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” the FDA’s device center director, Jeff Shuren, said in an agency statement.
“Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients,” added Shuren, alongside an FDA reminder that users should not make medical decisions based on the device’s readings without first talking to their healthcare provider.
Dexcom said it plans to launch Stelo this summer as a cash-pay product, with users covering the cost out-of-pocket. Worn on the back of the upper arm, the sensor can deliver 24/7 glucose readings to a smartphone app for up to 15 days.
“Dexcom continues to lead innovation in the CGM market, with a long list of first-in-market advances,” said the company’s chief commercial officer, Jake Leach. “Dexcom was the first to connect CGM to multiple insulin delivery devices, the first to connect CGM to a smartphone, the first to replace fingersticks for treatment decisions, and now is creating a new category by bringing the first glucose biosensor cleared for use over-the-counter.”
The company has long been looking to broaden the use of its wearable glucose sensors, taking its first steps in Europe with 2022’s similarly pared-down Dexcom One. The One—and debuting earlier this year, the One+—are aimed at people with Type 1 and Type 2 diabetes that don’t need an extensive, feature-filled glucose monitoring system.
Dexcom now aims to adopt that portfolio approach on U.S. shores, with its premium G7 sensor aimed at patients with full reimbursements, and the Stelo designed to expand into markets with little access or health insurance coverage.