FDA authorizes first wearable to track both ketones and blood sugar

People with diabetes can now get an early warning when a dangerous complication starts to build in their bodies.

The U.S. Food and Drug Administration (FDA) on Tuesday authorized the first wearable sensor that continuously tracks ketones—chemicals the body makes when it burns fat instead of sugar for fuel.

It is also the first device anywhere to monitor ketones and blood sugar at the same time, the FDA said.

When ketones climb too high, they can cause diabetic ketoacidosis, or DKA. The American Diabetes Association warns that DKA can worsen within hours and lead to coma or death if it goes untreated.

Hospital admissions for DKA have risen 55% over the past decade, according to Abbott, which makes the device.

Early symptoms are often mistaken for a stomach bug or another common infection, which delays care. Most people also 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, who directs the FDA’s Center for Devices and Radiological Health.

The sensor, called Libre Duo 10 Day, sticks to the skin and reads both ketones and glucose in the fluid just beneath the surface every minute, day and night.

Readings travel wirelessly to a smartphone app that shows current levels and whether they are trending up or down. 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.

About 40.1 million Americans have diabetes, according to the U.S. Centers for Disease Control and Prevention (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 who take insulin or glucose-lowering medications.

Six studies enrolling more than 600 people supported the decision, the FDA said. The device accurately tracked meaningful changes in ketone levels across the full 10-day wear period and flagged elevated ketones before DKA took hold.

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.

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