Abbott Secures FDA Clearance for OTC CGMs for General Public, Adults with T2D Who do not Use Insulin

The US Food and Drug Administration (FDA) today granted clearance for 2 new over-the-counter (OTC) continuous glucose monitoring (CGM) systems, one for adults with type 2 diabetes (T2D) who do not use insulin and another for adults without diabetes who want to improve and understand their health, according to a company announcement.

The FDA granted clearance for Libre Rio™ and Lingo™ systems, which are based on Abbott’s FreeStyle Libre® CGM technology, according to the June 10, 2024, press release.

"There is no one-size-fits all approach for glucose monitoring, which is why we've designed different products for different people – all based on the same world-leading biowearable technology," Lisa Earnhardt, executive vice president and group president of Medical Devices at Abbott, said in the announcement.

The first OTC CGM, Libre Rio, is for adults 18 years and older with T2D who do not use insulin and who manage their diabetes through lifestyle modification. The system includes a biosensor worn on the back of the arm for up to 15 days along with a reader or compatible smartphone app to display glucose levels. The Libre Rio is the first OTC CGM system with a measurement range of 40 mg/dL to 400 mg/dL, allowing for the measurement of extremely high or extremely low glucose levels, according to Abbott.

The second system, Lingo, is for individuals 18 years and older who are looking to improve their overall health and wellness. The CGM system will track glucose levels and provide personalized insights and coaching for users. The system consists of a biosensor worn on the upper arm for 14 days that continuously streams glucose data to a coaching application on the user’s smartphone.

“CGMs are a tool I recommend to my patients to raise their overall awareness of factors that affect their glucose and are an invaluable holistic wellness solution," Fred St. Goar, MD, cardiologist and medical director of El Camino Health Heart and Vascular Institute, said in the release. “Research has shown that overall lower glucose exposure in the general population is associated with reduced long-term risk to developing cardiovascular disease, diabetes, Alzheimer's and certain cancers. Making CGMs widely available will undoubtedly have a dramatic effect on the overall health and well-being of the broader population.”

The FDA clearances are the most recent approvals of OTC CGMs in the US. In March, the FDA granted marketing clearance for the Dexcom Stelo Glucose Biosensor System for adults with or without diabetes.

Reference: Abbott receives U.S. FDA clearance for two new over-the-counter continuous glucose monitoring systems. Abbott. News item. June 10, 2024. Accessed June 10, 2024. https://abbott.mediaroom.com/2024-06-10-Abbott-Receives-U-S-FDA-Clearance-for-Two-New-Over-the-Counter-Continuous-Glucose-Monitoring-Systems