The Dexcom logo is seen on a smartphone screen and within the background.
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Dexcom on Tuesday announced that its recent over-the-counter continuous glucose monitor called Stelo has been cleared to be used by the U.S. Food and Drug Administration, and it would be available for purchase online this summer.
Continuous glucose monitors, or CGMs, are small sensors that poke through the skin to trace glucose levels in real time. They’re primarily utilized by patients with diabetes for the reason that information is wirelessly sent to a smartphone, which may also help alert users, their families and their doctors to emergencies.
Dexcom’s recent CGM is designed for patients with Type 2 diabetes who don’t use insulin, and it’s the primary glucose biosensor that doesn’t require a prescription, in response to a release Tuesday. This implies Stelo shall be accessible to individuals who don’t have insurance coverage for CGMs, Dexcom said.
There are greater than 25 million Type 2 diabetes patients within the U.S. that don’t use insulin, in response to the discharge from Dexcom. While Dexcom’s existing G7 CGM system is on the market to this population, patients need to get a prescription for it. Consequently, it isn’t easily accessible to all Type 2 patients.
“CGMs could be a powerful tool to assist monitor blood glucose. Today’s clearance expands access to those devices by allowing individuals to buy 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 greater than 2% in prolonged trading Tuesday.
Dexcom shared Stelo’s name, in addition to the undeniable fact that the device had been submitted to the FDA for review in February. The sensor shall be worn on the upper arm, and it lasts for as much as 15 days before it needs to get replaced, in response to Dexcom’s website.
Jake Leach, chief operating officer at Dexcom, told CNBC in February that Stelo may have its own unique platform and branding. The platform shall be tailored for the needs of those Type 2 patients, he said, which implies it would not include most of the alerts and notifications meant for diabetes patients liable to experiencing more serious emergencies.
“It’s designed to be a less complicated experience,” Leach said in an interview. “There’s a whole lot of individuals who may benefit.”
Leach said as Dexcom is capable of display the advantages of Stelo, the corporate believes insurance firms will eventually pay for it. He said Dexcom decided to get the product out to the market at an “approachable” money pay price first to assist get it into users’ hands quickly.
“I feel it is vital for people to have that insight — it’s like a mirror into their body,” he said. “It’s totally personal.”
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