The US Food and Drug Administration (FDA) has granted marketing authorization to the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, the first wearable device in the US to continuously track ketone levels and the first worldwide to pair continuous ketone and glucose monitoring in a single sensor.1
The authorization, announced by parent company Abbott on August 25, 2026, covers patients aged ≥2 years living with diabetes. The device measures both analytes in interstitial fluid every minute across a 10-day wear period and sends readings wirelessly to a compatible smartphone.1
"Today's authorization is a breakthrough for the safety of children and adults living with diabetes,” Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”1
Prior to this authorization, patients needing to track ketones relied on point-in-time urine or blood tests incapable of showing directional trends. Continuous glucose monitoring has become standard for many patients with type 1 diabetes, but ketone surveillance remained a separate, intermittent process disconnected from real-time glucose data. The Libre Duo 10 Day closes this gap by unifying both measurements on one platform capable of flagging rising ketones before diabetic ketoacidosis develops.1,2
Evidence Base for Authorization
The FDA's authorization rests on clinical and performance data submitted by Abbott Diabetes Care across 6 clinical studies enrolling >600 participants aged ≥2 years. Investigators evaluated the accuracy of the device's glucose and ketone sensing functionality across a wide range of glucose and ketone concentrations. Results demonstrated the sensor consistently tracked clinically meaningful shifts in ketone levels throughout the full 10-day wear period, including detection of rising ketone concentrations preceding onset of diabetic ketoacidosis.1
The FDA reviewed this evidence through the De Novo premarket pathway, reserved for low- to moderate-risk device types without an existing predicate. Abbott's submission followed a Breakthrough Device designation, granted earlier in development to expedite review of technologies addressing life-threatening or irreversibly debilitating conditions. Specific sensor accuracy statistics, such as mean absolute relative difference, do not appear in the FDA release, leaving device-level performance figures for clinicians to seek once product labeling becomes available.1
Libre Duo 10 Day regulatory pathway and safety controls
The device issues automatic alerts when ketone concentrations cross a threshold associated with elevated risk, intended to prompt patients and caregivers to act before diabetic ketoacidosis becomes a medical emergency. FDA notes ketone readings should be interpreted alongside glucose trends and clinical symptoms rather than as a standalone value. Alongside the De Novo authorization, the agency established special controls governing labeling and performance testing requirements applicable to the Libre Duo 10 Day.1
These special controls extend to any subsequent device of this type seeking market entry through the same classification. Combined with general controls already applicable to class II devices, they are intended to provide reasonable assurance of safety and effectiveness for this newly created device category.1
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