Abbott has announced that the U.S. Food and Drug Administration (FDA) has authorized its Libre Duo 10 Day system, a dual glucose‑ketone sensing technology. The new biowearable is designed to alert people living with diabetes of rising ketones that can lead to a diabetic ketoacidosis (DKA) emergency, a serious health complication for people with diabetes.

Libre Duo 10 Day is designed to deliver real-time visibility into glucose levels needed for daily diabetes management while also monitoring rising ketones in the background, avoiding additional mental or physical burden for people with diabetes, the company said. Abbott plans to launch Libre Duo 10 Day in the United States later this year.

It’s the first system to meet the FDA’s integrated continuous glucose monitoring (iCGM) standard and the new integrated continuous glucose and ketone monitoring (iCGK) standard, which establishes a benchmark for continuous ketone monitoring in the United States, according to Abbot.

DKA is the most common hyperglycemic emergency for people living with diabetes and can develop quickly when the body does not have enough insulin and then starts to break down fat for energy, causing ketone levels to rise to potentially dangerous levels in the blood. Hospital admissions for DKA have increased 55% over the past decade.

“As a physician, I see how quickly DKA can develop—and how often early warning signs or opportunities to measure ketones are missed,” said Jennifer Sherr, M.D., Ph.D., pediatric endocrinologist at Yale School of Medicine. “Abbott’s dual glucose-ketone system is meaningful because ketone data is collected in the background, helping provide earlier awareness of rising ketone levels.”  

Libre Duo 10 Day continuously monitors both glucose – the standard of care for daily diabetes management – and ketone levels. Unlike blood or urine ketone tests, which provide only a single point-in-time reading, the sensors continuously track ketones and are designed to alert people when ketones are rising, Abbott said.

“If glucose is the speedometer, ketones are like the check engine light—providing an alert that something may need attention,” said Chris Scoggins, executive vice president of Abbott’s diabetes care business. “Libre Duo 10 Day brings both glucose and ketone levels together in a single dashboard, providing a more complete picture to help people with diabetes make more informed decisions.”

Libre Duo 10 Day offers up to 10 days of wear⁸ and is intended for people with diabetes ages 2 and older. It uses the latest-generation Libre app available in the United States today and will integrate with the broader Libre digital health ecosystem, including LibreView for health care providers and LibreLinkUp for caregivers.

Abbott is working with leading pump companies to enable automated insulin delivery (AID) systems to connect with the sensors. The company expects Libre Duo 10 Day to work with Beta Bionics’ iLet and Sequel Med Tech’s twiist AID systems by the end of this year and with devices from Insulet and Tandem in 2027. Abbott and MiniMed are collaborating on an exclusive integration between Abbott-manufactured dual glucose-ketone sensors and MiniMed smart dosing systems, which is expected in 2027.