The Dexcom logo is seen on a smartphone screen and in the background.
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Dexcom on Tuesday announced that its latest over-the-counter continuous glucose monitor called Stelo has been cleared to be used by the U.S. Food and Drug Administration, and it is going to 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 used by patients with diabetes since the information is wirelessly sent to a smartphone, which may also help alert users, their families and their doctors to emergencies.
Dexcom’s latest CGM is designed for patients with Type 2 diabetes who don’t use insulin, and it’s the first glucose biosensor that doesn’t require a prescription, based on a release Tuesday. This implies Stelo will likely be accessible to individuals who wouldn’t have insurance coverage for CGMs, Dexcom said.
There are greater than 25 million Type 2 diabetes patients in the U.S. that don’t use insulin, based on the release from Dexcom. While Dexcom’s existing G7 CGM system is offered to this population, patients must get a prescription for it. Consequently, it is not easily accessible to all Type 2 patients.
“CGMs is usually 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 indisputable fact that the device had been submitted to the FDA for review in February. The sensor will likely be worn on the upper arm, and it lasts for as much as 15 days before it needs to get replaced, based on Dexcom’s website.
Jake Leach, chief operating officer at Dexcom, told CNBC in February that Stelo can have its own unique platform and branding. The platform will likely be tailored for the needs of those Type 2 patients, he said, which suggests it is going to not include lots of the alerts and notifications meant for diabetes patients prone to experiencing more serious emergencies.
“It’s designed to be an easier experience,” Leach said in an interview. “There’s a variety of individuals who may benefit.”
Leach said as Dexcom is capable of exhibit the advantages of Stelo, the company 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 believe it is important for people to have that insight — it’s like a mirror into their body,” he said. “It’s totally personal.”
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