FDA clears dual ketone glucose wearable
The FDA has authorized Abbott's Libre Duo 10 Day, the first wearable sensor to continuously track both ketones and blood sugar.
The U.S. Food and Drug Administration authorized the first wearable sensor for continuous ketone tracking on Tuesday, August 29, 2026. The device, called Libre Duo 10 Day, is also the first anywhere to monitor ketones and blood sugar simultaneously, according to the agency.
This provides an early warning for diabetic ketoacidosis (DKA), a dangerous complication where ketones climb too high. The American Diabetes Association warns DKA can worsen within hours and lead to coma or death if untreated. Hospital admissions for DKA have risen 55% over the past decade, according to Abbott, the device's manufacturer.
Early symptoms are often mistaken for a stomach bug or common infection, delaying care. Most people do not keep a blood ketone meter at home. "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," said Dr. Michelle Tarver of the FDA's Center for Devices and Radiological Health.
How the Sensor Works
The sensor sticks to the skin, reading both ketones and glucose in interstitial fluid every minute, day and night. Readings travel wirelessly to a smartphone app that shows current levels and trends. The app sounds an alert when ketones reach a concerning level.
Until now, people had to check ketones separately using blood or urine tests. Those tests capture a single moment and cannot show whether levels are climbing or falling. "As a physician, I see how quickly DKA can develop, and how often early warning signs or opportunities to measure ketones are missed," said Dr. Jennifer Sherr, a pediatric endocrinologist at Yale School of Medicine.
Authorized Use and Supporting Data
About 40.1 million Americans have diabetes, according to the CDC. The new device is authorized for anyone with diabetes ages 2 and older. Abbott says it is aimed at people at higher risk of elevated ketones, including those on insulin or glucose-lowering medications.
Six studies enrolling more than 600 people supported the FDA decision. The device accurately tracked meaningful ketone changes across the full 10-day wear period and flagged elevated ketones before DKA took hold.
| Feature | Detail |
|---|---|
| Device Name | Libre Duo 10 Day |
| Measurements | Continuous ketones and blood glucose |
| Reading Frequency | Every minute |
| Wear Period | 10 days |
| Authorized Age | 2 years and older with diabetes |
| Data Destination | Smartphone app with alerts |
Abbott plans to launch the sensor in the United States later this year. The company is also working to connect it with automated insulin delivery systems.
The FDA cautions that ketone readings should always be considered alongside glucose numbers and a person's symptoms. This new tool represents a significant shift from sporadic testing to continuous, dual monitoring for millions managing diabetes.
