The Libre Duo 10 Day is authorized for people 2 years and older with diabetes
TUESDAY, Sept. 1, 2026 (HealthDay News) — The U.S. Food and Drug Administration has authorized the Libre Duo 10-Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.
Prior to this authorization, the FDA granted Breakthrough Device designation to the Libre Duo 10-Day, which is now the first U.S. wearable device that continuously monitors ketone levels, as well as the first to continuously monitor both ketones and glucose in a single device.
The authorization was based on review of clinical and performance data from six clinical studies, enrolling a pooled 600 participants. The results showed that the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period and across a range of ketone and glucose levels. Additionally, it identified elevated ketone levels before the onset of diabetic ketoacidosis.
“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,” Michelle Tarver, M.D., Ph.D., from the FDA Center for Devices and Radiological Health, said in a statement.
Marketing authorization for the Libre Duo 10 Day was granted to Abbott Diabetes Care.
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