FDA clears OTC CGMs for general public, adults with type 2 diabetes who do not use insulin
Click Here to Manage Email Alerts
Key takeaways:
- The Abbott Libre Rio was cleared for adults with type 2 diabetes who do not use insulin.
- The FDA cleared the Abbott Lingo for adults who want to track glucose to improve their overall health.
The FDA granted clearance for two new over-the-counter continuous glucose monitoring systems, one for adults with type 2 diabetes who do not use insulin and another for adults without diabetes, according to an industry press release.
The FDA cleared the Abbott Libre Rio for adults aged 18 years and older with type 2 diabetes. The OTC CGM is designed for adults who do not use insulin and who manage their diabetes through lifestyle modification. The system, which is based on the Abbott FreeStyle Libre CGM, 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 has a measurement range of 40 mg/dL to 400 mg/dL, allowing for the measurement of extremely high or extremely low glucose levels.
The second system cleared is the Abbott Lingo for adults aged 18 years and older who are looking to improve overall health and wellness. The CGM 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 U.S. As Healio previously reported, the FDA granted marketing clearance for the Dexcom Stelo Glucose Biosensor System in March for adults with or without diabetes.
Read more about
Click Here to Manage Email Alerts