FDA authorizes Abbott’s wearable to monitor ketone and glucose in diabetes patients

The U.S. Food and Drug Administration said on Tuesday it authorised ​Abbott Laboratories’ glucose monitor, making it the first ‌device that continuously monitors both ketone levels ​and blood sugar.

Here are ⁠some details:

The device branded as Libre Duo 10 Day is designed for a 10-day ‌wear period for people aged 2 years and older living with diabetes.

The biowearable is designed to ‌alert ⁠people of rising ketones that can ⁠lead to a diabetic ketoacidosis (DKA) emergency, a serious health complication for people with diabetes.

Unlike earlier ketone tests ​that offered ‌only separate, one-time readings, Abbott’s device continuously monitors both ketone and glucose levels, displaying real-time trends.

The device can send automatic ‌alerts, which may help patients and ​caregivers recognize rising ketones before DKA becomes a medical emergency.

“If glucose is ⁠the speedometer, ketones are like the check engine light—providing an alert that something ‌may need attention,” said Chris Scoggins, executive vice president of Abbott’s diabetes care business.

The device brings both glucose and ketone levels together in a single dashboard, providing a more complete picture to ‌help people with diabetes make more informed decisions, ​added Scoggins.

Abbott is working with leading pump companies to enable automated insulin ⁠delivery systems to connect with the sensors.

⁠The company said the device integrates with the Libre app and expects ‌Libre Duo 10 Day to work with devices from Insulet and Tandem ​in 2027.