An FDA clearance has been given to Dexcom’s first over-the-counter CGM Stelo

An FDA clearance has been given to Dexcom’s first over-the-counter CGM Stelo

The U.S. Food and Drug Administration has approved the use of Dexcom’s new over-the-counter continuous glucose monitor, called Stelo, and it will be accessible for online purchase this summer, the company stated on Tuesday.

CGMs, or continuous glucose monitors, are small skin-piercing sensors that measure blood sugar levels in real time. Since the information is wirelessly transmitted to a smartphone, which can help users, their families, and their doctors become aware of emergencies, people with diabetes are the ones who use them the most.

According to a release on Tuesday, Dexcom’s new CGM is the first prescription-free glucose biosensor and is intended for those with Type 2 diabetes who do not take insulin. According to Dexcom, this implies that anyone without insurance coverage for CGMs will have access to Stelo.

The press release from Dexcom states that around 25 million Americans with Type 2 diabetes do not take insulin. This demographic can use the G7 CGM system that Dexcom currently offers, however it requires a prescription. It is therefore not easily accessible to all Type 2 patients.

“CGMs can be an effective tool for blood glucose monitoring. The FDA’s Center for Devices and Radiological Health director, Dr. Jeff Shuren, stated in a release that “today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider.”

Tuesday’s extended trading saw a more than 2% increase in Dexcom shares.

Stelo’s name was disclosed by Dexcom, along with the information that the device had been submitted for FDA approval in February. The Dexcom website states that the upper arm sensor has a maximum 15-day lifetime before having to be changed.

Stelo will have its own distinct platform and identity, according to a February statement made to CNBC by Dexcom’s chief operating officer, Jake Leach. According to him, the platform will be customized to meet the needs of these Type 2 patients, meaning many of the alerts and messages meant for diabetics who run the danger of experiencing serious problems won’t be present.

According to Leach, “it’s meant to be a simpler experience,” during an interview. “A lot of people could gain from this.”

According to Leach, Dexcom thinks insurance companies would eventually pay the bill for Stelo as long as the company can prove its benefits. According to him, Dexcom made the decision to launch the product at a cash pay pricing that was “approachable” in order to facilitate its rapid user adoption.

“It’s like a mirror into their body, and I think it’s important for people to have that insight,” he stated. “It’s extremely personal.”

Topics #CGM Stelo #Dexcom #diabetes #Health #news #Stelo

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