Wearable Device Monitors Ketone Levels and Blood Sugar

FDA has granted Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged two years and older living with diabetes. The agency says the device is the first wearable in the U.S. to continuously monitor both ketones and blood sugar (glucose) together in a single device.

The authorization is based on clinical and performance data submitted by Abbott. The clinical program included data from six clinical studies that together enrolled more than 600 participants to evaluate the accuracy of the device’s ketone and glucose monitoring functionality across a range of ketone and glucose levels, according to an agency release. The results demonstrated that the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period, including identifying elevated ketone levels before the onset of diabetic ketoacidosis, it says.