The FDA on March 5 cleared the Dexcom Stelo Glucose Biosensor System for use, making it the first continuous glucose monitoring device to be available over the counter.
Stelo is intended for adults 18 and older who do not use insulin, including people with Type 2 diabetes who are treating their condition with oral medications. The monitoring device is a small sensor that tracks glucose levels in real time and is paired with an application on a user's smartphone or other device. Measurements and trends are updated in the app every 15 minutes.
"CGMs can be a powerful tool to help monitor blood glucose," Jeff Shuren, MD, director of the FDA's center for devices and radiological health, said in a news release. "Today's clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider."
Dexcom said there are approximately 25 million people in the U.S. with Type 2 diabetes who do not take insulin. The company offers another CGM that is available only with a prescription. Stelo is expected to be available for purchase without a prescription this summer.
The company did not mention pricing details in its announcement about Stelo's FDA clearance.