Abbott’s Lingo and Libre Rio CGM devices, designed for general health and Type 2 diabetes management respectively, receive FDA approval, offering advanced metabolic health tracking for US consumers.
Two innovative over-the-counter continuous glucose monitoring (CGM) systems have been approved for use in the United States. Abbott Laboratories has announced that the U.S. Food and Drug Administration (FDA) has greenlit its latest biowearable devices: Lingo and Libre Rio. These devices are poised to enhance metabolic health monitoring for a wide range of users.
The Lingo device is targeted at general consumers aiming to improve their overall health and wellness. Meanwhile, the Libre Rio monitor is designed specifically for adults with Type 2 diabetes who do not use insulin but manage their condition through lifestyle changes.
Advanced Technology for Diverse Needs
Both CGM systems are based on Abbott’s well-established FreeStyle Libre technology, which is currently utilized by approximately 6 million people worldwide. “The newly cleared systems have been intentionally designed to meet different needs,” Abbott stated in a news release.
“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, Abbott’s executive vice president and medical devices business group president. “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.”
Enhancing Metabolic Health
Abbott highlighted a study from the University of North Carolina, which revealed that only 12% of Americans are metabolically healthy based on five key indicators, including blood glucose levels. This statistic underscores the potential impact of these new devices. Additionally, a survey conducted by The Harris Poll and commissioned by Abbott found that 82% of Americans would alter their habits if a biowearable device provided data to help them manage their health.
The Lingo device features a biosensor worn on the upper arm for two weeks, continuously streaming glucose data to a smartphone app. This data offers insights into how an individual’s body responds to food, exercise, and stress, facilitating personalized health management.
Addressing Type 2 Diabetes
For adults managing Type 2 diabetes, the Libre Rio CGM offers a measurement range of 40 to 400 mg/dL, capable of tracking both extremely low and high glucose events. Abbott noted that approximately 38.4 million Americans live with diabetes, highlighting the significant need for effective glucose monitoring solutions. The Libre Rio will complement Abbott’s existing FreeStyle Libre 2 and FreeStyle Libre 3 systems, which cater to patients with Type 1, Type 2, and gestational diabetes.
Abbott’s FreeStyle Libre systems are already available over-the-counter in more than 50 countries but have required prescriptions in the United States until now. The launch of Lingo and Libre Rio as over-the-counter devices marks a significant expansion in accessibility, potentially transforming diabetes and metabolic health management for millions of Americans.
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