FDA Clears Wearable Device That Monitors Glucose and Ketones Together

The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose-Ketone Monitoring System for people with diabetes aged 2 and older. It is the first wearable to track both glucose and ketones in real time, potentially reducing the need for separate tests. The device can alert users when ketone levels rise, helping to prevent diabetic ketoacidosis.

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The device measures both biomarkers every minute in interstitial fluid, streaming data to a smartphone app with trend arrows. Abbott's clinical program enrolled over 600 participants across six studies, showing the sensor could detect ketone elevations before DKA developed. The 10-day wear period represents a significant shift from single-point blood or urine tests, which only capture momentary readings.

The FDA's review emphasized that early detection of rising ketones is critical for preventing diabetic ketoacidosis, a life-threatening complication. The device is intended for patients with type 1 or type 2 diabetes using insulin or other glucose-lowering medications. Abbott plans to launch the product later this year, and the FDA