US medical technology company Abbott has received the US Food and Drug Administration (FDA) approval for its two new over-the-counter continuous glucose monitoring (CGM) systems.
The new CGM systems, Lingo, and Libre Rio, are developed based on Abbott’s FreeStyle Libre CGM technology, currently used by around six million people worldwide.
Lingo is designed for health and wellness, and Libre Rio is for adults with Type 2 diabetes who do not use insulin and manage their diabetes through lifestyle modifications.
Abbott medical devices executive vice president and group president Lisa Earnhardt said: “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.
“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 personalised coaching to promote actionable lifestyle changes.”
Designed as a consumer biowearable, Lingo is intended for consumers aged 18 years and above, seeking to improve their overall health and wellness.
The system tracks glucose and provides personalised insights and customised coaching to help people create healthy habits, retrain their metabolism, and improve overall well-being.
Using a biosensor, worn on the upper arm for 14 days, Lingo continuously streams glucose data to a smartphone coaching application, providing insights on food, exercise, and stress.
Libre Rio is intended for people with Type 2 diabetes, aged 18 years and above, who do not use insulin and typically manage their diabetes through lifestyle modifications.
It is the first OTC CGM system with a 40-400 mg/dL measurement range that covers extremely low or high glucose events, and Abbott’s first such system for people with diabetes in the US.
Abbott will offer Libre Rio as part of its Libre portfolio of CGM systems, which includes FreeStyle Libre 2 and FreeStyle Libre 3 systems, for all types of diabetes.
Unlike FreeStyle Libre systems, which require a prescription, Libre Rio will make it easier for diabetes patients in the US to try a CGM, said the medical device company.
