The FDA has authorized Abbott Diabetes Care’s Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, the first wearable device in the U.S. to continuously monitor both glucose and ketone levels.
The device is authorized for people ages 2 and older with diabetes, according to an Aug. 25 FDA news release. It is also the first device worldwide to continuously monitor glucose and ketone levels using a single wearable.
Libre Duo 10 Day measures ketone and glucose levels in the fluid beneath the skin every minute and sends readings wirelessly to a compatible smartphone. The device can automatically alert users when ketone levels reach a potentially concerning level.
The FDA based its authorization on data from six clinical studies involving more than 600 participants ages 2 and older. The device accurately tracked clinically meaningful differences in ketone levels throughout the 10-day wear period and identified elevated levels before diabetic ketoacidosis developed.
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