Abbott receives FDA nod for 2 OTC continuous glucose monitoring systems
Abbott has obtained permission from the Food and Drug Administration for two new over-the-counter continuous glucose monitoring systems—Lingo and Libre Rio, which are based on Abbott's world-leading FreeStyle Libre continuous glucose monitoring technology, which the company noted is now used by about 6 million people globally.
The newly cleared systems have been intentionally designed to meet different needs—Lingo for consumers who want to better understand and improve their health and wellness, and Libre Rio for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.
"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, executive vice president 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."
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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.
According to a University of North Carolina study, only 12% of Americans are metabolically healthy based on five key indicators of metabolic health, including glucose levels, indicating that most of the U.S. population has room to improve their metabolism. In addition, in a recent online consumer survey conducted by The Harris Poll on behalf of Abbott, 82% of Americans say they would change their habits if a biowearable provided actionable, personalized coaching to help them manage their health, Abbott said.
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.
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"Continuous glucose monitors 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," said Fred St. Goar, cardiologist and medical director of El Camino Health Heart and Vascular Institute. "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 continuous glucose monitors widely available will undoubtedly have a dramatic effect on the overall health and well-being of the broader population."