Abbott secures CE mark for world’s first glucose-ketone wearable

USA—Abbott has obtained CE mark approval for two new glucose–ketone sensing systems designed for people living with diabetes, marking a regulatory milestone for the company’s next-generation biowearable technology.

The approved devices, Libre Duo and Libre Duo 10 Day, represent the first systems of their kind cleared to continuously track both glucose and ketone levels in real time.

The approval strengthens Abbott’s position in the continuous glucose monitoring (CGM) market and expands its diagnostic capabilities beyond glucose-only tracking, which has traditionally defined wearable diabetes management tools.

Real-time metabolic monitoring and early DKA alerts

The Libre Duo systems measure glucose and ketone levels at one-minute intervals, providing continuous metabolic insights for individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D).

In addition, the devices deliver early alerts for potential diabetic ketoacidosis (DKA), a serious complication linked to insulin deficiency.

By combining glucose and ketone monitoring in a single wearable platform, Abbott enables patients to detect early metabolic imbalance without relying on intermittent blood or urine testing.

This shift supports faster intervention and reduces the risk of emergency complications associated with delayed detection.

Digital health integration and connected care

Abbott has integrated the Libre Duo systems into its broader Libre digital health ecosystem, which connects CGM devices, mobile applications, and cloud-based data platforms.

Through this ecosystem, users can share real-time glucose and ketone data with healthcare professionals and caregivers, enabling coordinated and proactive care decisions.

The company has also aligned this connectivity with broader digital health trends, similar to partnerships across the wearable ecosystem involving platforms such as Apple and fitness-integrated technologies like those developed by Oura, which continue to expand patient-facing access to health data through consumer devices like the Apple Watch.

Wear duration and planned market rollout

Libre Duo is designed for up to 15 days of wear in adults, while Libre Duo 10-day supports up to 10 days of use in individuals aged two years and older.

Abbott plans to introduce the systems in select European markets later this year, following CE mark approval.

Meanwhile, the devices remain under regulatory review by the U.S. Food and Drug Administration for potential entry into the United States.

During Abbott’s recent quarterly update, leadership indicated expectations for a possible FDA decision in the second half of 2026, although timelines remain subject to regulatory processes.

Clinical context and disease burden

Diabetic ketoacidosis occurs when the body lacks sufficient insulin, triggering fat breakdown for energy and increasing ketone production.

As ketones accumulate, blood acidity rises, creating a life-threatening condition if not treated promptly.

The Centers for Disease Control and Prevention identifies DKA as a leading cause of death in younger patients with type 1 diabetes and a major contributor to diabetes-related hospitalizations.

Abbott executives have noted that patients often describe the risk of complications as a persistent concern in daily life.

The company positions Libre Duo as a tool that delivers earlier physiological insight, enabling users and clinicians to respond before conditions escalate.

Competitive landscape in Continuous Glucose Monitoring

Abbott continues to compete in a rapidly expanding CGM market, where demand for continuous, real-time metabolic data is rising.

The company’s diabetes care division remains a key revenue driver within its medtech portfolio, supported by strong global adoption of its Libre product line.

At the same time, competitors such as Dexcom continue to strengthen their market presence, particularly in the United States, while also expanding into broader wellness applications through device integrations and digital partnerships.