FDA Clears Dexcom’s First Over-the-Counter CGM, Stelo

Dexcom announced on Tuesday that its new over-the-counter continuous glucose monitor, Stelo, has received clearance from the U.S. Food and Drug Administration and will be available for online purchase this summer.

“Continuous glucose monitors, or CGMs, are small sensors that poke through the skin to track glucose levels in real time,” the company explained. “They are primarily used by patients with diabetes since the information is wirelessly sent to a smartphone, which can help alert users, their families, and their doctors to emergencies.”

Stelo
Stelo: Continuous glucose monitor on the upper arm, lasts 15 days, simpler experience for users. (Credits: Dexcom)

According to Dexcom, Stelo is specifically designed for patients with Type 2 diabetes who do not use insulin, making it the first glucose biosensor that does not require a prescription. This accessibility will benefit individuals who lack insurance coverage for CGMs.

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 is available to this population, patients need a prescription for it, limiting accessibility.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, emphasized the significance of this clearance: “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.”

Shares of Dexcom rose over 2% in extended trading following the announcement.

Dexcom G7 CGM
Dexcom aims for Stelo accessibility: initial cash pay price, insurance coverage expected later. (Credits: Dexcom)

Stelo, which was submitted to the FDA for review in February, will be worn on the upper arm and lasts up to 15 days before replacement, according to Dexcom’s website.

Jake Leach, chief operating officer at Dexcom, explained that Stelo will have its unique platform and branding tailored to the needs of Type 2 patients. Unlike CGMs for more critical situations, Stelo will offer a simpler experience without many of the alerts and notifications.

“It’s designed to be a simpler experience,” Leach said. “There’s a lot of people who could benefit.”

Leach also expressed confidence that as Dexcom demonstrates the benefits of Stelo, insurance companies will eventually cover it. Initially, the company aims to make the product accessible at an “approachable” cash pay price to swiftly reach users.

“I think it’s important for people to have that insight — it’s like a mirror into their body,” Leach commented. “It’s very personal.”

Sajda Parveen
Sajda Parveen
Sajda Praveen is a market expert. She has over 6 years of experience in the field and she shares her expertise with readers. You can reach out to her at [email protected]
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