Abbott Secures CE Mark for World’s First Dual Glucose-Ketone Sensor, Revolutionizing DKA Management

MedTech Dive USA

Overview

Abbott has received European CE Mark approval for its Libre Duo and Libre Duo 10 Day systems, the world’s first dual-analyte sensors capable of continuously measuring both glucose and ketones. This technology aims to assist diabetes patients in managing blood glucose and detecting rising ketone levels, a critical warning sign for diabetic ketoacidosis (DKA). Abbott plans to launch the system in select European countries later this year, marking a significant step in comprehensive diabetes care.

In Depth

Background: Advancements in Diabetes Management and Unmet Needs

Continuous Glucose Monitoring (CGM) systems have significantly advanced diabetes management. However, glucose levels alone are insufficient to fully assess the risk of acute complications like Diabetic Ketoacidosis (DKA). DKA is a severe condition, potentially life-threatening for type 1 diabetes patients, caused by excessive ketone body production due to insulin deficiency. Traditional ketone measurement methods, primarily blood and urine tests, hinder real-time continuous monitoring. To address this gap, Abbott has focused on developing technology capable of simultaneously measuring both glucose and ketones.

Libre Duo: The World’s First Dual-Analyte Sensor

Abbott’s newly CE-marked Libre Duo and Libre Duo 10 Day systems are the world’s first wearable biosensors capable of continuously measuring both glucose and ketone levels at one-minute intervals. Worn on the skin, these sensors provide real-time interstitial fluid glucose and ketone concentrations. The ability to detect rising ketones early is particularly valuable for both patients and healthcare providers in situations where DKA risk is difficult to assess based solely on glucose levels, such as pump failures, insulin administration interruptions, or during intense exercise or illness-related stress. The Libre Duo can be worn for up to 15 days, and the Libre Duo 10 Day for up to 10 days.

Clinical Significance and Future Prospects

The introduction of the Libre Duo system marks a new era in diabetes management. Real-time ketone information allows patients to identify DKA risk earlier and seek prompt medical intervention. This not only prevents severe complications but also reduces the need for hospitalization, significantly improving the quality of life for people with diabetes. Abbott plans to launch this system in select European countries later this year, with FDA review also underway in the United States. As competitors explore the ketone monitoring market, Abbott’s move solidifies the importance of ketone monitoring in the future of diabetes care.