The U.S. Food and Drug Administration has granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, approved for use in patients aged two and above with diabetes. This marks a significant milestone: it is the first FDA-cleared wearable in the country capable of continuously tracking ketone levels, and the first device anywhere to combine real-time glucose and ketone monitoring within one wearable sensor.
CDRH Director Michelle Tarver highlighted the device’s potential to give families and clinicians a critical head start against dangerous ketone spikes, framing the clearance as a meaningful advance in patient safety.
Roughly 40 million Americans currently manage diabetes, with an estimated 2.1 million living with type 1 diabetes, a population particularly vulnerable to diabetic ketoacidosis (DKA) — a fast-developing, potentially fatal complication triggered by excess ketone production. Previously, ketone testing relied on isolated point-in-time readings. The Libre Duo 10 Day instead samples interstitial fluid every 60 seconds across its 10-day wear cycle, transmitting trend data to a paired smartphone and issuing alerts when ketone levels climb toward risk thresholds.
Supporting clinical evidence came from six studies spanning over 600 participants, confirming the sensor’s ability to detect meaningful ketone shifts — including early rises preceding DKA onset — alongside reliable glucose tracking.
The product received Breakthrough Device designation ahead of its review and was authorized through the De Novo pathway, alongside newly established special controls governing labeling and performance standards for this novel device category.
This is a sensitive health-related topic — if you or someone you know needs personalized guidance on diabetes management or DKA risk, please consult a healthcare provider.
Written By: Sayan Das
Graphics by: Pramit Hazra
