FDA Approves New Over-the-Counter Glucose Monitors from Abbott

The Lingo combines a biosensor worn on the arm and a smartphone app.

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iStock/Sundry Photography

Abbott today announced FDA clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo and Libre Rio, which are based on Abbott's FreeStyle Libre continuous glucose monitoring technology.

Abbott's consumer biowearable, Lingo, is designed for consumers 18 years and older who are looking to improve their overall health and wellness. Lingo will track glucose and provide personalized insights and customized coaching to help people create healthy habits, retrain their metabolism and improve their overall well-being.  

The Lingo system combines a biosensor that is worn on the upper arm for 14 days and continuously streams glucose data to a coaching application on a smart phone – translating the body's language and giving insights on the person's reaction to food, exercise and life's daily stressors.

Libre Rio will be Abbott's first over-the-counter CGM system for people with diabetes in the U.S. It is designed for people ages 18 and older with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications. Libre Rio is the first over-the-counter CGM system with a measurement range of 40-400 mg/dL, allowing for measurement of extremely low or high glucose events.

Libre Rio will join Abbott's overall Libre portfolio of CGM systems. The Libre portfolio in the U.S. consists of the FreeStyle Libre 2 and FreeStyle Libre 3 systems for people with all types of diabetes – Type 1, Type 2 and gestational. FreeStyle Libre systems require a prescription and have wide reimbursement by most major insurers in the U.S. Libre Rio may make it easier for Americans with diabetes to try a CGM and begin to see progress toward their health goals, empowering them with information to discuss with their healthcare provider at their next visit.

Libre systems consist of a biosensor placed on the back of the arm for up to 15 days, and a reader or a compatible smartphone app, which displays glucose measurements.