Dexcom announces Stelo has been cleared by the FDA

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The Dexcom logo is seen on a smartphone screen and in the background.

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Dexcom on Tuesday announced that its new over-the-counter continuous glucose monitor called Stelo has been cleared for use by the U.S. Food and Drug Administration, and it will be available for purchase online this summer.

Continuous glucose monitors, or CGMs, are small sensors that poke through the skin to track glucose levels in real time. 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.

Dexcom’s new CGM is designed for patients with Type 2 diabetes who do not use insulin, and it is the first glucose biosensor that does not require a prescription, according to a release Tuesday. This means Stelo will be accessible to people who do not have insurance coverage for CGMs, Dexcom said.

There are more than 25 million Type 2 diabetes patients in the U.S. that do not use insulin, according to the release from Dexcom. While Dexcom’s existing G7 CGM system is available to this population, patients have to get a prescription for it. As a result, it’s not easily accessible to all Type 2 patients.

“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,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a release.

Shares of Dexcom popped more than 2% in extended trading Tuesday.

Dexcom shared Stelo’s name, as well as the fact that the device had been submitted to the FDA for review in February. The sensor will be worn on the upper arm, and it lasts for up to 15 days before it needs to be replaced, according to Dexcom’s website.

Jake Leach, chief operating officer at Dexcom, told CNBC in February that Stelo will have its own unique platform and branding. The platform will be tailored for the needs of these Type 2 patients, he said, which means it will not include many of the alerts and notifications meant for diabetes patients at risk of experiencing more serious emergencies.

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

Leach said as Dexcom is able to demonstrate the benefits of Stelo, the company believes insurance companies will eventually pay for it. He said Dexcom decided to get the product out to the market at an “approachable” cash pay price first to help get it into users’ hands quickly.

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

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