Global healthcare company Abbott has received CE Mark approval for Libre Duo and Libre Duo 10 Day, the world’s first continuous dual glucose and ketone monitoring systems for people living with diabetes. The innovative technology enables users to track both glucose and ketone levels every minute through a single wearable sensor, providing real-time insights that could help reduce the risk of diabetic ketoacidosis (DKA), a potentially life-threatening diabetes complication.

The approval marks a major advancement in diabetes management, as it is the first time people with diabetes will be able to continuously monitor ketone levels without relying on conventional blood or urine testing methods. Abbott plans to begin rolling out the Libre Duo systems in select European markets later this year.

DKA occurs when the body lacks sufficient insulin and begins breaking down fat for energy, resulting in the accumulation of ketones in the bloodstream. If left untreated, elevated ketone levels can rapidly progress to severe complications, including coma and death. According to diabetes experts, ketone levels can rise independently of glucose levels, making early detection particularly challenging through traditional monitoring approaches.

The Libre Duo systems are designed to address this challenge by continuously measuring both biomarkers, enabling users to identify rising ketone levels before they escalate into a medical emergency. The technology provides ongoing visibility into metabolic changes rather than relying on single-point blood or urine measurements.

The CE Mark approval covers two product variants. Libre Duo offers up to 15 days of wear and is intended for adults aged 18 years and older, while Libre Duo 10 Day provides up to 10 days of continuous monitoring and is approved for individuals aged two years and above. Clinical studies demonstrated strong accuracy and reliability across both devices, with the 10-day sensor specifically designed to support active younger users.

The new systems will integrate with Abbott’s Libre digital health ecosystem, allowing users to securely share glucose and ketone data with healthcare professionals and caregivers. Abbott is also collaborating with insulin pump manufacturers to support integration with automated insulin delivery systems, creating a more connected diabetes management experience.

Chris Scoggins, Executive Vice President of Abbott’s Diabetes Care Business, said the company continues to drive innovation in health technology by addressing critical unmet needs in diabetes care. He noted that the constant risk of severe complications remains a significant concern for people living with diabetes and their families, and that continuous ketone monitoring can provide earlier warning signs when intervention is most needed.

The technology aligns with recent recommendations from diabetes experts and organisations such as Breakthrough T1D, which have highlighted the potential benefits of continuous ketone monitoring as part of comprehensive diabetes management.

Abbott cited growing concerns around the increasing incidence of DKA globally. Research indicates that hospital admissions related to DKA have risen significantly over the past decade, while studies have shown that DKA rates are increasing among both Type 1 and Type 2 diabetes patients. The condition is also responsible for substantially more diabetes-related hospitalisations than hypoglycaemia, underscoring the need for improved prevention and early detection tools.

The Libre Duo systems are particularly intended for people at higher risk of DKA, including those with Type 1 diabetes and insulin-dependent Type 2 diabetes, as well as patients using sodium-glucose cotransporter-2 (SGLT2) inhibitors. By providing continuous visibility into ketone trends alongside glucose readings, the technology aims to help users and healthcare providers make more informed decisions and respond earlier to potential health risks.

Abbott’s latest innovation builds on the success of its Libre continuous glucose monitoring portfolio, which is currently used by more than eight million people across over 60 countries. The company believes the addition of continuous ketone monitoring represents a significant step forward in improving diabetes outcomes and reducing the burden of acute complications for patients worldwide.