Signal FDA Clears First Dual Glucose-Ketone Continuous Monitoring Wearable

Summary

The FDA authorized Abbott's Libre Duo 10 Day continuous dual glucose-ketone monitoring system on August 25, 2026, for people with diabetes aged 2 and older. It is the first wearable device worldwide to continuously track both ketone and glucose levels together in a single sensor, measuring every minute, day and night, via fluid just beneath the skin. Readings transmit wirelessly to a compatible smartphone, showing current levels and trend direction. The device can send automatic alerts when ketone levels reach a concerning threshold, helping patients and caregivers catch rising ketones before diabetic ketoacidosis (DKA) becomes a medical emergency. The clinical program supporting authorization included six clinical studies enrolling more than 600 participants aged 2 and older to validate accuracy across a range of ketone and glucose levels. Abbott plans to launch the device in the U.S. later in 2026.