FDA Authorizes First Wearable Device That Monitors Ketone and Glucose Levels

The FDA approved Abbott’s Libre Duo 10-Day Continuous Dual Glucose-Ketone Monitoring System for individuals aged 2 years and older, marking the first U.S. wearable to continuously measure ketones and the first worldwide device to track both ketone and glucose. Data from six studies with >600 participants demonstrated accurate detection of clinically significant ketone changes, early alerts for potential diabetic ketoacidosis, and real-time transmission of readings and trends to a smartphone.