The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar together in a single device.

“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”

According to the CDC, an estimated 40.1 million Americans live with diabetes. For the estimated 2.1 million with type 1 diabetes, rising ketones can lead to diabetic ketoacidosis (DKA), a life-threatening complication. Until now, ketone monitoring required separate tests providing single measurements. The Libre Duo 10 Day continuously measures both ketones and glucose every minute, sending wireless alerts to a smartphone when ketone levels reach concerning thresholds.

The FDA’s authorization is based on clinical data from six studies enrolling more than 600 participants aged 2 years and older, demonstrating accurate tracking of ketone changes over the 10-day wear period. The device, granted Breakthrough Device designation, was authorized through the De Novo pathway to Abbott Diabetes Care.