Dexcom announced on Tuesday that its new over-the-counter continuous glucose monitor (CGM), named Stelo, has received clearance from the U.S. Food and Drug Administration (FDA). It will be available for purchase online starting this summer.
CGMs are small sensors that penetrate the skin to monitor glucose levels in real-time, primarily for patients with diabetes.
They transmit information wirelessly to smartphones, providing alerts to users, their families, and doctors during emergencies.
Designed specifically for patients with Type 2 diabetes who do not use insulin, Stelo is the first glucose biosensor that does not require a prescription.
This makes it accessible to individuals without insurance coverage for CGMs, according to Dexcom.
The release from Dexcom noted that there are more than 25 million Type 2 diabetes patients in the U.S. who do not use insulin.
While Dexcom’s existing G7 CGM system serves this population, it requires a prescription, limiting accessibility.
“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,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
Following the announcement, Dexcom’s shares rose more than 2% in extended trading on Tuesday.
Stelo, submitted for FDA review in February, will be worn on the upper arm and can function for up to 15 days before needing replacement.
Jake Leach, Dexcom’s chief operating officer, previously highlighted Stelo’s unique platform and branding, emphasizing its tailored approach for Type 2 diabetes patients.
This includes simplifying the user experience by excluding many alerts and notifications aimed at patients prone to more severe emergencies related to diabetes.
“It’s designed to be a simpler experience,” Leach said. “There’s a lot of people who could benefit.”
While Dexcom anticipates demonstrating Stelo’s benefits to insurance companies eventually, initially, the company aims to make it accessible at an affordable cash pay price to quickly reach users.
“I think it’s important for people to have that insight — it’s like a mirror into their body,” Leach added. “It’s very personal.”
