Abbott achieves FDA clearance for new continuous glucose monitoring systems

11 Jun 2024 --- Abbott has received clearance from the US Food and Drug Administration (FDA) for two new over-the-counter continuous glucose monitoring systems. Libre Rio targets people with type 2 diabetes, while Lingo is designed for adults wanting to understand and improve their health. The new systems are based on Abbott’s FreeStyle sensing technology. 

Libre Rio is designed for adults with type 2 diabetes who do not use insulin but manage their diabetes with lifestyle modifications. According to the company, it is the first over-the-counter continuous glucose system with a measurement range of 40–400 mg/dL, enabling the measurement of extremely low or high glucose events. 

Lingo is a biowearable designed for adults over 18. It tracks glucose and provides personalized insights and coaching to help users create healthy habits and retrain their metabolism. 

“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,” says 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.”

The company is also developing a sensor to measure both glucose and ketone. 

Diabetes management 
Industry experts expect continuous glucose monitoring systems to play an increasingly important role in diabetes management, replacing traditional monitors that require finger pricks. 

Until now, Abbott’s FreeStyle Libre systems have only been available through prescription in the US. These FreeStyle Libre 2 and FreeStyle Libre 3 systems target people with all types of diabetes (type 1, type 2 and gestational).

The company’s new Libre Rio addition will be available over the counter. It will help US citizens with diabetes try a continuous glucose monitoring system to see progress toward their health goals and provide information to follow up with their healthcare provider. 

The biosensors of the continuous glucose monitoring systems are linked to a smartphone app.The FreeStyle Libre systems help people improve their glucose control, lower their hemoglobin levels (HbA1c) in the blood, decrease diabetes-related hospital admissions and improve their quality of life. 

Users place a biosensor on the back of their arm for up to 15 days, connecting it to a reader or a compatible smartphone app to display glucose measurements. 

Metabolic health 
A healthy blood sugar level is one key aspect of metabolic health. In a recent poll commissioned by Abbott, most US respondents say they would change their habits if a biowearable provided “actionable, personalized coaching to help them manage their health.” 

Lingo combines a biosensor worn on a consumer’s upper arm for 14 days. This system continuously streams glucose data to a coaching application on a smartphone, which translates the consumer’s body language and provides insights into their reaction to food, exercise and daily stressors. 

Dr. Fred St. Goar, cardiologist and medical director of El Camino Health Heart and Vascular Institute, US, comments: “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.” 

“Research has shown that overall lower glucose exposure in the general population is associated with reduced long-term risk of developing cardiovascular disease, diabetes, Alzheimer’s and certain cancers. Making continuous glucose monitors widely available will undoubtedly dramatically affect the overall health and well-being of the broader population.” 

By Jolanda van Hal