Dexcom’s over-the-counter glucose monitor has received FDA clearance

For people diagnosed with type 2 diabetes, a brand new over-the-counter continuous glucose monitor (CGM) is on the horizon. Dexcom’s newest device, called Stelo, will reportedly receive FDA approval for online availability by summer 2024.

Dexcom announced that the U.S. Food and Drug Administration given settlement of medical products on March 5, a. Stelo is meant to be used by individuals with type 2 diabetes who don’t use insulin for treatment. Thanks to its over-the-counter status, a health care provider’s prescription isn’t required to buy the monitor, making it more accessible to people without insurance.

CGMs are tiny sensors that may track glucose levels through the skin, giving patients real-time information throughout the day that might be sent to their phones. With this information, users may have higher insight into their current health status and can give you the option to notify their family or doctor in the event that they have any concerns. The increased availability of CGM with this approval will enable more Americans to be accurately diagnosed with the disease. In a press release, Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, discussed these health equity efforts.

“CGMs can be a powerful tool to help monitor blood glucose levels. Today’s approval expands access to these devices, allowing individuals to purchase CGMs without involving a healthcare professional,” Dr. Shuren said. “Making valuable information about their health available to more people, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”

This message can be especially helpful for people of color because type 2 diabetes is probably the most common form affecting ethnic and racial minorities. Black adults are 60% more prone to be diagnosed than their white counterparts, According to Northwest medicine. This latest medical advancement from Dexcom will provide people who find themselves often disenfranchised within the healthcare industry with access to latest resources.

Patients 18 years of age or older can wear Stelo for as much as 15 days. The included app updates your glucose measurements and trends every quarter-hour. Further pricing and in-store availability details have yet to be announced.