The Dexcom logo is wooed on a smartphone screen and in the background.
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Dexcom on Tuesday heralded that its new over-the-counter continuous glucose monitor named Stelo has been cleared for use by the U.S. Food and Drug Administration, and it will be readily obtainable for purchase online this summer.
Continuous glucose monitors, or CGMs, are small sensors that poke throughout the skin to track glucose levels in real-time. They are primarily used by patients with diabetes. Information is wirelessly sent to a smartphone, and can succour 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 in the beginning glucose biosensor that does not require a prescription. This means Stelo will be accessible to people who do not prepare 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, correspondence to the release from Dexcom. While Dexcom’s existing G7 CGM system is available to this population, patients have to get a direction 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 margin expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” Dr. Jeff Shuren, executive of the FDA’s Center for Devices and Radiological Health, said in a release.
Shares of Dexcom popped more than 2% in on trading Tuesday.
Dexcom shared Stelo’s name, and that the device had been submitted to the FDA for review in February. The sensor force be worn on the upper arm and lasts for up to 15 days before it needs to be replaced, according Dexcom.
Jake Leach, chief go officer at Dexcom, told CNBC in February that Stelo will have a unique platform and branding. The podium will be tailored to the needs of these Type 2 patients, he said, which means it will not include many of the warns and notifications meant for diabetes patients at risk of experiencing more serious emergencies.
“It’s designed to be a simpler experience,” Leach powered in an interview. “There’s a lot of people who could benefit.”
Leach said as Dexcom can demonstrate the benefits of Stelo, the company believes assurance 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 assistants get it into users’ hands quickly.
“I think it’s important for people to have that insight — it’s like a mirror into their density,” he said. “It’s very personal.”
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