FDA Authorizes First Wearable Device That Monitors Ketone and Glucose Levels

The FDA has authorized the Libre Duo 10 Day, the first wearable device that continuously monitors both ketone and glucose levels in real time, for people aged 2 and older with diabetes. The device addresses a critical safety gap by allowing patients to detect rising ketone levels early, potentially preventing diabetic ketoacidosis (DKA), a life-threatening complication that previously required separate testing with only single-point measurements. The authorization was based on clinical data from over 600 participants demonstrating the device's accuracy in monitoring both ketones and glucose levels continuously.