The Dexcom logo will appear on your smartphone screen and background.
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dexcom on tuesday announced The company’s new over-the-counter continuous glucose monitor, called Stelo, has been cleared for use by the U.S. Food and Drug Administration and will be available for purchase online this summer.
A continuous glucose monitor (CGM) is a small sensor that penetrates the skin and tracks glucose levels in real time. Because the information is transmitted wirelessly to smartphones, it is primarily used by diabetics to help alert users, their families, and doctors of emergencies.
Dexcom’s new CGM is designed for type 2 diabetics who do not use insulin and is said to be the first glucose biosensor that does not require a prescription. release Tuesday. This means people who don’t have insurance against CGM can also use Stelo, he said Dexcom.
According to a Dexcom release, there are more than 25 million people in the United States with type 2 diabetes who do not use insulin. Dexcom’s existing G7 CGM system is available to this population, but patients must obtain a prescription for that system. Therefore, it is not easily accessible to all Type 2 patients.
“CGMs can be a powerful tool to help monitor blood sugar levels. Today’s approval expands access to these devices by allowing individuals to purchase CGMs without the involvement of a healthcare provider.” said Dr. Jeff Shuren, director of the FDA Device Center. Radiological Health says: release.
Dexcom stock soared more than 2% in after-hours trading on Tuesday.
Dexcom shared Stelo’s name and the fact that the device has been submitted to the FDA for review. During February. The sensor is worn on the upper arm and lasts up to 15 days before needing to be replaced. Dexcom website.
Dexcom chief operating officer Jake Leach told CNBC in February that Stelo would have its own platform and branding. He said the platform will be tailored to the needs of these type 2 patients, so it won’t include many of the alerts and notifications for people with diabetes who are at risk for more serious emergencies.
“It’s designed to be a simpler experience,” Leach said in an interview. “There are a lot of people who will benefit.”
Leach said the company believes that if Dexcom can demonstrate Stelo’s benefits, insurance companies will eventually pay for it. He said Dexcom decided to first bring the product to market at an “affordable” cash price to get it into the hands of users quickly.
“I think it’s important for people to have that insight. It’s like a mirror to your body,” he says. “It’s very personal.”
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