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.
