Abbott wins CE mark for dual glucose-ketone sensor

Abbott (NYSE:ABT) announced today that it received CE mark approval for its dual glucose-ketone sensing technology for people with diabetes.

The company said its dual sensor marks a world first, continuously measuring glucose and ketone levels every minute. Branded as Libre Duo and Libre Duo 10 Day, the sensors provide real-time visibility into glucose levels as a standard CGM like Abbott’s FreeStyle Libre system does, but also into rising ketones that can lead to a diabetic ketoacidosis (DKA) emergency.

Abbott said this clearance marks the first time people with diabetes can monitor ketones without traditional blood or urine tests. It plans to begin the rollout of its Libre Duo systems in select European countries later this year.

EVP of Diabetes Care Chris Scoggins explained the potential of the sensor in an interview with Drug Delivery Business News last year. Earlier this year, Abbott shared study data outlining the growing burden of DKA.

More about DKA and how the new Abbott sensor works

In people with diabetes, DKA develops when the body doesn’t have enough insulin and begins breaking down fat for energy. This causes ketones to rise to dangerous levels in the blood.

Libre Duo systems continuously monitor both glucose and ketone levels to reduce the reliance on tests that capture a single moment in time. This helps people monitor their glucose levels while alerting them to rising ketones so they can act sooner to avoid a potential emergency.

Abbott said that Libre Duo offers up to 15 days of wear for adults ages 18 and older under CE Mark. Libre Duo 10 Day offers up to 10 days of wear for people ages 2 and older. The company said clinical data indicated that a 10-day sensor can help active youth complete the full wear period.

Libre Duo systems integrate with Abbott’s Libre digital health ecosystem to enable users to share data with caregivers and providers. The company also has work underway with pump makers to enable integration with automated insulin delivery systems.

“Abbott has a long-established pattern of setting the pace in health tech innovation,” said Scoggins. “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.”