The Dexcom logo appears on smartphone screens and backgrounds.
Pavlo Gonchar | Sopa Images | Light Rocket | Getty Images
Dexcon Tuesday declare Its new over-the-counter continuous glucose monitor, Stelo, has been approved 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 pierces the skin to track blood sugar levels instantly. They are mainly used by diabetics. Messages are sent wirelessly to smartphones and can help alert users, their families and doctors to emergencies.
Designed for patients with type 2 diabetes who do not take insulin, Dexcom’s new CGM is the first glucose biosensor that does not require a prescription. Dexcom said this means people without CGM insurance can also use Stelo.
According to a release from Dexcom, more than 25 million people with type 2 diabetes in the United States do not use insulin. While Dexcom’s existing G7 CGM system is available to this population, patients must obtain a prescription to use it. Therefore, not all type 2 patients have easy access to it.
“CGMs can be powerful tools to help monitor blood sugar. Today’s approval expands the use of these devices, allowing individuals to purchase CGMs without the involvement of a health care provider,” said Dr. Jeff Shuren, director of FDA Devices and Centers for Disease Control and Prevention.radiological health, says freed.
Dexcom shares rose more than 2% in after-hours trading on Tuesday.
Dexcom shares Stelo’s name and the device has been submitted for FDA review In February. According to reports, the sensor will be worn on the upper arm and can be used for up to 15 days before needing to be replaced. Dexcon.
Dexcom chief operating officer Jake Leach told CNBC in February that Stelo will have a unique platform and brand. The platform will be customized to the needs of these type 2 patients, he said, meaning it won’t include many of the alerts and notifications targeted at diabetics who are at risk for more serious emergencies.
“It’s designed to provide a simpler experience,” Leach said in an interview. “There are a lot of people that could benefit.”
Leach said that because Dexcom was able to demonstrate Stelo’s benefits, the company believes insurance companies will eventually pay for it. Dexcom decided to bring the product to market first at an “approachable” cash-pay price to help it get into users’ hands quickly, he said.
“I think it’s important for people to have this insight – it’s like a mirror looking into them,” he said. “It’s very personal.”
Don’t miss these stories from CNBC PRO:
About The Author
