FDA Clears Abbott’s Libre Duo 10 Day, First U.S. Wearable to Continuously Monitor Ketones and Glucose

The U.S. Food and Drug Administration on Tuesday authorized Abbott Diabetes Care’s Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people age 2 and older living with diabetes, marking the first wearable device authorized in the United States to continuously monitor ketone levels. The FDA also said it is the first device authorized in the U.S. to continuously monitor both ketones and blood sugar with a single sensor.

The distinction matters because rising ketone levels can signal the early stages of diabetic ketoacidosis, or DKA, a serious and potentially life-threatening diabetes complication that can develop quickly. Until now, ketones have generally been checked with point-in-time blood or urine tests. A wearable that tracks them continuously could give patients and caregivers earlier warning that intervention is needed. The FDA said ketone information should be interpreted together with glucose readings and symptoms.

The Libre Duo 10 Day uses a sensor worn on the body to measure glucose and ketones in interstitial fluid just beneath the skin. It provides readings every minute and sends them wirelessly to a compatible smartphone. The system can also send automatic alerts when ketone levels reach concerning thresholds, alongside continuous glucose monitoring.

The FDA said its decision was based on clinical and performance data submitted by Abbott. According to the agency, the clinical program included six studies involving more than 600 participants ages 2 and older. In those studies, the FDA said, the device accurately tracked clinically meaningful differences in ketone levels and identified elevated ketones before the onset of diabetic ketoacidosis. The device was authorized through the FDA’s De Novo pathway, used for novel low- to moderate-risk devices without a legally marketed predicate, and had previously received Breakthrough Device designation.

“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”

The authorization has broad relevance given the scale of diabetes in the United States. The FDA cited Centers for Disease Control and Prevention estimates that about 40.1 million Americans are living with diabetes, including about 2.1 million with Type 1 diabetes.