FDA authorizes first wearable that tracks ketones and blood sugar together

The U.S. Food and Drug Administration announced on August 25, 2026 that it has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. According to the agency, it is the first wearable device in the United States that continuously measures ketone levels, and the first in the world to track ketones and blood sugar (glucose) together in a single device.

Continuous readings instead of single measurements

The device measures both values in the fluid just beneath the skin, every minute, day and night, and sends readings wirelessly to a compatible smartphone. Users see their current ketone and glucose levels and whether they are trending up or down, and the system can send automatic alerts when ketone levels reach a concerning threshold. The FDA notes that ketone information should always be interpreted in the context of glucose readings and symptoms.

Until now, people who needed to monitor ketones used tests that provided a single measurement at one point in time, which could not show whether ketones were rising or falling.

Why ketones matter

Ketones are produced when the body uses fat instead of glucose for energy. When too many ketones build up, it can lead to diabetic ketoacidosis, or DKA — a serious complication that can develop quickly and become life-threatening if left untreated. Citing the Centers for Disease Control and Prevention, the FDA says an estimated 40.1 million Americans live with diabetes and about 2.1 million have type 1 diabetes, for whom blood sugar is only part of the picture.

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

Clinical data and the regulatory path

The authorization was based on a review of clinical and performance data that included six clinical studies enrolling more than 600 participants aged 2 and older, covering a range of ketone and glucose levels. Results showed the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period, including identifying elevated ketones before the onset of DKA.

Marketing authorization was granted to Abbott Diabetes Care through the De Novo premarket review pathway, which is used for new types of low- to moderate-risk devices. Alongside it, the FDA is establishing special controls covering labeling and performance testing. The device previously received Breakthrough Device designation, and the authorization aligns with the agency’s Home as a Health Care Hub initiative.