Abbott receives FDA authorization for world's first dual glucose-ketone sensing technology for people with diabetes

Libre Duo 10 Day is a first-of-its-kind, two-in-one biowearable that monitors glucose and helps detect rising ketone levels that can lead to diabetic ketoacidosis (DKA), a serious health condition for people living with diabetes Designed to seamlessly address a critical gap in ketone monitoring, providing needed health data without adding burden on people living with diabetes Integrates with the latest-generation Libre app available in the U.S. and the full Libre digital health ecosystem; designed for compatibility with leading automated insulin delivery (AID) systems ABBOTT PARK, Ill. , Aug. 25, 2026 /PRNewswire/ -- Abbott (NYSE: ABT ), the global healthcare leader, today announced U.S. Food and Drug Administration (FDA) authorization of its Libre Duo 10 Day system, the world's first 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 delivers 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. Abbott plans to launch Libre Duo 10 Day in the United States later this year. First-of-its-kind technology Libre Duo 10 Day received De Novo authorization after securing breakthrough device designation from the FDA through a program designed to help people gain faster access to innovative medical technologies. 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. Monitoring ketones in the background DKA is the most common hyperglycemic emergency for people living with diabetes, 1,2 and hospital admissions for DKA have increased 55% over the past decade. 3 DKA 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. 4 According to the American Diabetes Association, DKA can progress within hours and, if left untreated, can lead to coma or death. 4 While clinical guidance is to test ketones during illness or periods of elevated glucose, the majority of people do not have access to a blood ketone meter at home 5 and early signs of rising ketones are often mistaken for common infections, resulting in delayed treatment . 2,6,7 "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." How Libre Duo 10 Day works 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. "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 decisio...