Abbott Gains FDA Approval for Two New Over-the-Counter Continuous Glucose Monitoring Systems

Monday, June 10, 2024

Abbott recently gained clearance from the U.S. Food and Drug Administration (FDA) for two new over-the-counter continuous glucose monitoring (CGM) systems: Lingo™ and Libre Rio™.

These systems, based on Abbott's FreeStyle Libre® CGM technology, are tailored to address different needs. Lingo is aimed at individuals seeking to enhance overall health and wellness, while Libre Rio is designed for adults with Type 2 diabetes who manage their condition through lifestyle changes rather than insulin.

Abbott's medical devices business, emphasized the importance of offering diverse products to cater to varied needs, all built upon Abbott's leading biowearable technology.

Lingo is designed for consumers aged 18 and older looking to improve overall health and wellness. It tracks glucose levels and offers personalized insights and coaching to help users form healthy habits, retrain their metabolism, and improve well-being.

A University of North Carolina study found that only 12 percent of Americans are metabolically healthy based on five key indicators, including glucose levels. Additionally, an Abbott-commissioned Harris Poll survey revealed that 82 percent of Americans would change their habits if provided with actionable, personalized coaching through a biowearable device.

Lingo comprises a biosensor worn on the upper arm for 14 days, continuously streaming glucose data to a smartphone coaching app, providing insights on the user’s reactions to food, exercise, and daily stressors.

Libre Rio is Abbott’s first over-the-counter CGM system in the U.S., designed for adults with Type 2 diabetes who do not use insulin and manage their diabetes through lifestyle modifications. It can measure glucose levels from 40-400 mg/dL, covering both extremely low and high glucose events.

Diabetes affects about 38.4 million people in the U.S. Libre Rio, previously available only by prescription, will now be accessible over-the-counter. It complements Abbott’s existing Libre portfolio, which includes systems for all types of diabetes—Type 1, Type 2, and gestational.

These systems, which require a prescription, are widely reimbursed by major insurers in the U.S. They are used by millions globally to improve glucose control, lower HbA1c, reduce diabetes-related hospital admissions, and enhance quality of life.

Abbott continues to innovate for people with diabetes, expanding manufacturing capacity and developing a pioneering sensor that measures both glucose and ketones.







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