Dexcom announces that Stelo has been cleared by the FDA

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

Continuous glucose monitors, or CGMs, are small sensors that pierce through the skin to track glucose levels in real time. They are primarily used by diabetic patients as information is sent wirelessly to a smartphone, which can help alert users, their families and their doctors of emergencies.

Dexcom’s new CGM is designed for type 2 diabetes patients who don’t use insulin, and it’s the first glucose biosensor that doesn’t require a prescription, according to exemption Tuesday. That means the Stelo will be available to people who don’t have insurance coverage for CGMs, Dexcom said.

There are more than 25 million type 2 diabetes patients in the U.S. who do not use insulin, according to the Dexcom announcement. While Dexcom’s existing G7 CGM system is available for this population, patients must obtain a prescription for it. As a result, it is not readily available for all type 2 patients.

“CGMs can be a powerful tool to help monitor blood sugar. Today’s authorization expands access to these devices by allowing people to purchase CGMs without the involvement of a healthcare provider,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health Devices, said in exemption.

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

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

Jake Leach, chief operating officer of Dexcom, told CNBC in February that Stelo will have its own unique platform and brand. The platform will be tailored to the needs of these type 2 patients, he said, meaning it won’t include many of the alerts and notifications designed for diabetes patients at risk of more serious emergencies.

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

Leach said that because Dexcom is able to demonstrate the benefits of Stelo, the company believes insurance companies will eventually pay for it. He said Dexcom decided to market the product at an “affordable” cash price to help get it into the hands of consumers quickly.

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

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