The Dexcom logo appears on the smartphone screen and in the background.
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Discom A new over-the-counter continuous glucose monitoring device called Stelo has been cleared for use by the U.S. Food and Drug Administration and will be available for purchase online this summer, it announced Tuesday.
Continuous glucose monitors, or CGMs, are small sensors that penetrate the skin to track glucose levels in real time. They are primarily used by diabetics as information is sent wirelessly to a smartphone, which can help alert users, their families and doctors to emergency situations.
Designed for patients with type 2 diabetes who do not use insulin, Dexcom's new CGM is the first glucose biosensor that does not require a prescription, according to a statement released Tuesday. This means Stelo will be more accessible to people who don't have insurance coverage for CGMs, Dexcom said.
There are more than 25 million Type 2 diabetes patients in the United States who do not use insulin, according to a statement from Dexcom. While Dexcom's current G7 CGM system is available for this population, patients must obtain a prescription for it. As a result, it is not easily accessible to all type 2 patients.
“Continuous glucose monitors can be a powerful tool to help monitor blood glucose. Today’s authorization expands access to these devices by allowing individuals to purchase CGM devices without the involvement of a health care provider,” Dr. Jeff Shuren, director of the Center for Devices and Monitoring of the US Food and Drug Administration. Radiation Health said in a statement.
Dexcom shares rose more than 2% in extended trading Tuesday.
Dexcom shared the name Stelo, as well as the fact that the device was submitted to the FDA for review in February. The sensor will be worn on the upper arm, lasting up to 15 days before it needs to be replaced, according to Dexcom's website.
Stelo will have its own unique platform and brand, Jake Leach, Dexcom's chief operating officer, told CNBC in February. He added that the platform will be designed to suit the needs of these type 2 patients, which means it will not include many alerts and notifications intended for diabetics who are at risk of experiencing more serious emergencies.
“It was designed to be a simpler experience,” Leach said in an interview. “There are a lot of people who could benefit.”
Dexcom is able to demonstrate the benefits of Stelo, and the company believes insurers will eventually pay for it, Leach said. Dexcom decided to bring the product to market at an “easy” cash price first to help get it into users' hands quickly, he said.
“I think it's important for people to have that insight, it's like a mirror to their bodies,” he said. “It's very personal.”
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