Dexcom’s Over-The-Counter Glucose Monitor Gains FDA Clearance

Dexcom announces the FDA approval of its over-the-counter glucose monitor, which will provide access to new medical resources for those lacking insurance.

For those diagnosed with Type 2 Diabetes, a new over-the-counter continuous glucose monitor (CGM) is on the horizon. Dexcom’s latest device, called Stelo, will allegedly gain FDA approval for online availability by summer 2024.

Dexcom announced that the U.S. Food and Drug Administration granted the medical device clearance on March 5, per CNBC. Stelo is intended for use by people with Type 2 diabetes who do not use insulin for treatment. With its over-the-counter status, a doctor’s prescription is not needed to obtain the monitor, making it more accessible to those without insurance coverage.

CGMs are small sensors that can track glucose levels through the skin, giving patients real-time information throughout the day that can be sent to their phones. With this information, users will have a better grasp of their current health and can notify their families or doctors in case of concern. CGMs’ expanded availability through this approval will allow more Americans to be on top of their diagnosis. In a press release, Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, elaborated on this stride for health equity.

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider,” expressed Dr. Shuren. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”

This news will be especially helpful for people of color, as Type 2 Diabetes is the most common form that impacts ethnic and racial minorities. Black adults are 60% more likely to be diagnosed than their white counterparts, according to Northwestern Medicine. This new medical advancement by Dexcom will ensure that those often disenfranchised in the health industry can have access to new resources.

Patients 18 or older can wear the Stelo for up to 15 days. An accompanying app updates information regarding glucose measurements and trends every 15 minutes. Further details on its price point and in-store availability have yet to be announced.