FDA Authorizes Abbott’s Libre Duo, First Continuous Glucose Ketone Monitor

The U.S. Food and Drug Administration (FDA) has authorized Abbott’s Libre Duo 10 Day system, the first continuous glucose ketone monitor cleared in the United States. The device is approved for people aged two years and older living with diabetes, and it is the first anywhere in the world to track both ketones and glucose together in a single wearable sensor.

“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.”

The DKA risk for people with diabetes

An estimated 40.1 million Americans live with diabetes, according to the Centers for Disease Control and Prevention, and about 2.1 million of them have type 1 diabetes. For those patients, blood sugar is only part of the picture. When the body burns fat instead of glucose for energy, it produces ketones, and too many can lead to diabetic ketoacidosis (DKA), a serious complication that can develop quickly and become life-threatening if left untreated.

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Until now, people who needed to watch their ketones had to rely on separate tests that give a single reading at one moment in time, with no way to tell whether levels were rising or falling.

How the continuous glucose ketone monitor works

The Libre Duo 10 Day builds on the continuous glucose monitoring already used by many people with diabetes, adding ketones to the same sensor. It measures ketone and glucose in the fluid just beneath the skin every minute, day and night. Readings travel wirelessly to a compatible smartphone, where users can see their current levels and whether they are trending up or down. The device can also send an automatic alert when ketones pass a concerning threshold, which may help patients and caregivers catch rising ketones before DKA becomes a medical emergency. The FDA notes that ketone readings should always be interpreted alongside glucose levels and symptoms.

Clinical evidence and regulatory pathway

The agency based its decision on clinical and performance data from six studies that together enrolled more than 600 participants aged two years and older. The 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 diabetic ketoacidosis.

The authorization is aligned with the FDA’s Home as a Health Care Hub Initiative, which focuses on patient-centered devices that fit more seamlessly into daily life at home. Before authorization, the agency granted the Libre Duo 10 Day Breakthrough Device designation to speed its development and review. Abbott received marketing authorization through the De Novo premarket review pathway, used for low- to moderate-risk devices of a new type. Along with the De Novo authorization, the FDA is establishing special controls that define requirements for labeling and performance testing.