Abbott wins FDA clearance for duo of over-the-counter CGMs

Abbott (NYSE:ABT) today announced FDA clearance for two over-the-counter continuous glucose monitor (CGM) systems, Lingo […]

Abbott (NYSE:ABT) today announced FDA clearance for two over-the-counter continuous glucose monitor (CGM) systems, Lingo and Libre Rio.
The company built both systems on its FreeStyle Libre CGM technology, but both aim to meet different needs. Lingo offers consumers a solution to better understand and improve their health and wellness. Libre Rio provides monitoring for adults with type 2 diabetes who aren’t on insulin and manage diabetes through lifestyle modifications.Abbott acknowledged this month that Lingo’s clearance came on May 29 but the Libre Rio sensor marks another entry into the over-the-counter CGM market. Like with the companies’ prescription CGMs, Libre Rio will rival Dexcom’s Stelo for people with type 2 diabetes not using insulin.

“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,” said Lisa Earnhardt, EVP and group president of Abbott’s medical devices business. “People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider. People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes.”

More about the Abbott Lingo sensor

Abbott launched Lingo in the U.K. last year. Abbott CEO Robert Ford previously claimed he sees Lingo as another growth driver for the company’s business. At the J.P. Morgan Healthcare Conference in January, Ford called Lingo a “life-changing” technology.

The consumer biowearable gives people 18 years of age and older a way to improve their overall health and wellness. It tracks glucose and provides personalized insights and customized coaching. This helps users create healthy habits, retrain their metabolism and improve their overall wellbeing.

Lingo features a biosensor worn on the arm for 14 days that continuously streams glucose data to a coaching application on a smartphone. It translates the body’s language and provides insights on a person’s reaction to food, exercise and life’s daily stressors.

A look at Libre Rio

Abbott said Libre Rio marks its first over-the-counter CGM for people with diabetes in the U.S. The company designed it for people aged 18 and older with type 2 diabetes not on insulin. It’s the first OTC CGM with a measurement range of 40-400 mg/dL, allowing for measurement of extremely low or high glucose events, the company said.

Libre Rio joins the Abbott portfolio of CGMs, which includes the popular FreeStyle Libre 2 and next-generation FreeStyle Libre 3. It could offer an easier path for Americans with diabetes to try a CGM and begin to see progress toward their health goals, Abbott says. The system provides information they can discuss with their healthcare provider as they improve their glucose control.

Abbott designed the sensor for a 15-day wear on the back of the arm. it connects to a compatible smartphone app that displays glucose measurements.

The company also continues development on a first-of-its kind, all-in-one sensor that measures both glucose and ketone.

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