FDA Authorizes First Wearable Dual Glucose-Ketone Sensor

The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose-Ketone Monitoring System for people ages 2 years and older with diabetes, the agency announced Tuesday.

As the first wearable device to track both ketones and glucose simultaneously, the system may reduce the need for traditional single-point blood or urine tests. It’s designed for patients who may be at higher risk of elevated ketones, including those with type 1 or type 2 diabetes who use insulin or other glucose-lowering medications.

“Until now, people who needed to monitor ketones had to do so separately, using tests that could only provide a single measurement at one point in time, which could not tell users if ketones were rising or falling,” the FDA noted. “Early detection of rising ketone levels is critical.”

Diabetic ketoacidosis (DKA) is a severe, potentially life-threatening diabetes complication that occurs when the body burns fat instead of glucose for energy, causing a dangerous buildup of ketones.

The authorization was based on a comprehensive review of clinical and performance data from six studies submitted by developer Abbott. The clinical program, which enrolled over 600 participants, demonstrated that the device accurately detects clinically meaningful shifts in ketone levels over its 10-day wear period, capturing elevated levels before DKA develops.

The sensor works by measuring glucose and ketone levels every minute in the fluid just under the skin, streaming real-time data and directional trend arrows directly to a smartphone app. If ketone levels cross a critical threshold, the device triggers automatic alerts, giving patients and caregivers crucial lead time to intervene before DKA becomes an emergency.

“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, 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.”

The FDA emphasized that users should always evaluate ketone trends alongside their current glucose readings and physical symptoms.

Abbott plans to launch Libre Duo 10 Day later this year.