Abbott Receives FDA Clearance for Two CGMs

Abbott received FDA clearances for two new over-the-counter CGM systems.

Image credits: Abbott

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

Related Abbott Wins FDA Breakthrough Device Designation

"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."

Lingo

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, Abbott said in a press release.

According to a University of North Carolina study, only 12 percent 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 percent of Americans say they would change their habits if a biowearable provided actionable, personalized coaching to help them manage their health.

The Lingo system combines a biosensor that is worn on the upper arm for 14 days5 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.  

"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, M.D., 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."

Libre Rio

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.

Diabetes is among the top public health challenges in the U.S., with approximately 38.4 million people living with the condition6. FreeStyle Libre systems have been available over-the-counter in more than 50 countries over the last decade; however, in the U.S., they have only been available through prescription.

Libre Rio will join Abbott's overall Libre portfolio of CGM systems, now used by about 6 million people across more than 60 countries. 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.

Clinical and real-world data from the millions of people that use FreeStyle Libre systems show that the technology helps people improve their glucose control, lower their HbA1c, decrease diabetes-related hospital admissions, and improve their quality of life7,8. 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 app9, which displays glucose measurements.

Abbott continues to invest in its world-leading innovation for people with diabetes, including expanding manufacturing capacity and developing a first-of-its-kind sensor that is designed to measure both glucose and ketone in the same sensor.

Sam Draper
July 8, 2024

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