Abbott Gains CE Mark for Dual Glucose-Ketone Sensor

Abbott has gained CE mark clearance for its dual glucose-ketone sensing technology for people with diabetes. According to the company, it’s the world’s first technology of its kind.

The systems are branded as Libre Duo and Libre Duo 10 Day and are designed to continuously measure glucose and ketone levels every minute, offering real-time visibility into glucose levels for daily management and rising ketones that can lead to a diabetic ketoacidosis (DKA) emergency.

This marks the first time diabetes patients will be able to monitor ketones without traditional blood or urine tests. Abbott said it plans to begin the Libre Duo systems’ launch in select European countries later this year.

Libre Duo provides up to 15 days of wear and will be available to adults ages 18 and older. Libre Duo 10 Day covers up to ten days of wear and is meant for people aged two and older. The company cited clinical data that indicated a ten-day sensor can help active youth complete the full wear period.

The systems will integrate with Abbott’s Libre digital health ecosystem so users can share glucose and ketone data with caregivers and healthcare providers. The company is also working with leading pump manufacturers to allow automated insulin delivery (AID) systems to connect with the sensors.

“Abbott has a long-established pattern of setting the pace in health tech innovation,” said Chris Scoggins, executive vice president of Abbott’s diabetes care business. “People living with diabetes routinely tell us that the risk of serious complications is a constant part of everyday life. Our Libre Duo systems offer people with diabetes, families and healthcare providers clearer, earlier information about what’s happening inside their body, allowing them to act sooner when safety matters most.”