FDA Authorizes First Wearable to Track Both Ketones and Blood Sugar

FDA Authorizes Dual-Tracking Wearable for Diabetes

The U.S. Food and Drug Administration (FDA) has authorized the Libre Duo 10 Day, the first wearable sensor that continuously tracks both ketones and blood sugar for people with diabetes.

This device, made by Abbott, is the first anywhere to monitor both markers at the same time, according to the FDA. The sensor is worn on the skin and sends real-time readings to a smartphone app.

What the Studies Show: Device Accuracy and Impact

Six studies involving over 600 people with diabetes supported the FDA's decision. The studies found that the Libre Duo 10 Day accurately tracked changes in ketone levels throughout the 10-day wear period.

The device was able to flag elevated ketones before diabetic ketoacidosis (DKA) developed, according to the FDA. These findings suggest the sensor may help users and clinicians detect dangerous trends earlier than traditional testing.

Why Ketone Monitoring Matters in Diabetes Management

Ketones are chemicals produced when the body burns fat instead of sugar for fuel. High ketone levels can lead to diabetic ketoacidosis, a life-threatening complication that can worsen within hours.

Until now, people with diabetes had to check ketones separately using blood or urine tests, which only provide a single snapshot in time. The new wearable offers continuous monitoring and alerts users when ketones reach concerning levels.

Who Can Use the Libre Duo 10 Day Sensor?

The FDA has authorized the device for anyone with diabetes aged 2 and older. Abbott says it is especially aimed at people at higher risk for elevated ketones, such as those taking insulin or glucose-lowering medications.

About 40.1 million Americans have diabetes, according to the U.S. Centers for Disease Control and Prevention (CDC). The sensor is expected to be available in the United States later this year.

Limitations and Practical Considerations

The FDA cautions that ketone readings from the device should always be interpreted alongside glucose levels and a person’s symptoms. The sensor is not a substitute for clinical judgment.

Traditional blood or urine ketone tests remain important in some situations, and early symptoms of diabetic ketoacidosis can still be mistaken for other illnesses. Users should consult their clinicians about how to respond to alerts from the device.