Abbott Receives FDA Approval for 2 New Over-the-Counter Glucose Monitoring Systems

The newly approved CGM systems, Lingo and Libre Rio, are designed to cater to different user requirements.

Abbott has received the US Food and Drug Administration (FDA) approval for the two new over-the-counter continuous glucose monitoring (CGM) systems, Lingo and Libre Rio.

As per the company, these new systems are based on Abbott's successful FreeStyle Libre technology, which is currently used by approximately six million people worldwide.

Tailored Solutions for Different Health Needs

The newly approved CGM systems, Lingo and Libre Rio, are designed to cater to different user requirements.

"There is no one-size-fits-all approach to glucose monitoring," said Lisa Earnhardt, executive VP

 and group president of Abbott's medical devices division.

Lingo is intended for consumers focused on improving their overall health and wellness, while Libre Rio is tailored for adults with Type 2 diabetes who do not use insulin and manage their condition through lifestyle changes.

"We've created different products for different people, all built on our world-leading biowearable technology. Diabetics need certain features like medication tracking and data sharing with healthcare providers. On the other hand, those without diabetes benefit from features that manage their metabolic health and provide personalized coaching to foster actionable lifestyle changes," she added.

Lingo for Overall Health

Abbott's new biowearable, Lingo, is designed for adults aged 18 and over who aim to enhance their overall health and wellness.

The Lingo system tracks glucose levels and provides personalized insights and coaching, helping users develop healthy habits, optimize their metabolism, and improve overall well-being.

A University of North Carolina study highlighted that, based on key health indicators, including glucose levels, only 12% of Americans are metabolically healthy.

Additionally, a recent survey conducted by The Harris Poll for Abbott found that 82% of Americans would change their habits if they had access to personalized coaching through a biowearable device.

Lingo includes a biosensor worn on the upper arm for 14 days and continuously streams glucose data to a smartphone app. The app translates the body's metabolic responses to food, exercise, and daily stress, providing users with valuable insights into their health.

"Continuous glucose monitors are a tool I recommend to my patients to increase awareness of factors affecting their glucose levels," said Dr Fred St Goar, Cardiologist and Medical Director of El Camino Health Heart and Vascular Institute.

According to him, research indicates that lower glucose exposure in the general population is linked to a reduced risk of cardiovascular disease, diabetes, Alzheimer's, and certain cancers. Making CGMs widely available will significantly improve overall health and well-being, Dr Fred noted.

Libre Rio: Expanding Access for Type 2 Diabetics

Libre Rio represents Abbott's first over-the-counter CGM system for people with diabetes in the United States. It is specifically designed for individuals aged 18 and over with Type 2 diabetes who do not use insulin and typically manage their condition through lifestyle modifications.

Libre Rio features a measurement range of 40-400 mg/dL, covering extremely low and high glucose events, making it a versatile tool for comprehensive glucose monitoring.

With approximately 38.4 million people living with diabetes in the US, the launch of Libre Rio aims to make CGM technology more accessible. Previously, FreeStyle Libre systems were only available by prescription in the US despite being available over the counter in over 50 countries.

Libre Rio will join Abbott's Libre portfolio of CGM systems, which includes FreeStyle Libre 2 and FreeStyle Libre 3. These systems cater to people with Type 1, Type 2, and gestational diabetes.