Admin_Adham
FDA Approves First OTC Continuous Glucose Monitor
The US Food and Drug Administration (FDA) has cleared Dexcom's Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitoring (CGM) system.
Unlike Dexcom's G6 and G7 CGM systems, the Stelo is intended for adults with or without diabetes who don't use insulin. "Importantly, this system is not for individuals with problematic hypoglycemia as the system it not designed to alert the user to this potentially dangerous condition," The FDA said on March 5, 2024 in a statement.
The Stelo system comprises a wearable sensor paired with an application installed on a smartphone or other reader device. It continuously measures, records, analyzes, and displays glucose values every 15 minutes. Each sensor can be worn for up to 15 days before it must be replaced. It is not intended to be used to make medical decisions without first checking with a healthcare provider.
Study data showed that the device performed similarly to other integrated CGMs, with similarly low adverse event rates.
"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," said Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health.
"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 US patients," Shuren said.
Stelo will be available without a prescription starting summer 2024, according to the company website.
Miriam E. Tucker is a freelance journalist based in the Washington, DC area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR's Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker.
