Abbott Libre Duo 10 Day has received U.S. Food and Drug Administration authorization, making it the world’s first dual glucose-ketone sensing biowearable for people living with diabetes. Abbott (NYSE: ABT), the global healthcare leader based in Abbott Park, Illinois, announced the milestone on August 25, 2026, positioning the new biowearable as a fresh category of continuous monitoring technology built to close a long-standing gap in home ketone testing. The company said it plans to launch the device in the United States later this year.
The FDA authorization follows a De Novo pathway after Abbott Libre Duo 10 Day secured breakthrough device designation, a program intended to speed patient access to novel medical technologies. Abbott said the system is the first to satisfy the agency’s integrated continuous glucose monitoring, or iCGM, standard while also meeting the newly established integrated continuous glucose and ketone monitoring, or iCGK, standard, which sets a formal U.S. benchmark for continuous ketone monitoring.
“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., a pediatric endocrinologist at Yale School of Medicine, who noted that collecting ketone data in the background helps provide earlier awareness of rising levels.
Diabetic ketoacidosis, or DKA, remains the most common hyperglycemic emergency among people with diabetes, and hospital admissions linked to the condition have climbed 55% over the past decade. DKA can develop within hours once the body lacks sufficient insulin and begins breaking down fat for energy, driving blood ketone levels upward, according to the American Diabetes Association.
Abbott Libre Duo 10 Day Addresses a Gap in At-Home Ketone Monitoring
Left untreated, the American Diabetes Association warns that DKA can progress to coma or death. Despite this risk, most people with diabetes lack a blood ketone meter at home, and early symptoms of rising ketones are frequently mistaken for common infections, a pattern that can delay treatment during a medical emergency. [Internal Link: Diabetic ketoacidosis: symptoms and treatment → /diabetic-ketoacidosis-symptoms-treatment] Abbott Libre Duo 10 Day was engineered specifically to close that visibility gap without adding extra testing steps to a person’s daily routine.
Unlike blood or urine ketone strips, which capture only a single point-in-time reading, Abbott Libre Duo 10 Day continuously tracks both glucose and ketones from one wearable sensor and is designed to alert users when ketone levels begin rising. Glucose monitoring remains the standard of care for daily diabetes management, while ketone tracking runs quietly in the background.
Chris Scoggins, executive vice president of Abbott’s diabetes care business, compared glucose data to a speedometer and ketone data to a vehicle’s check-engine light, explaining that Abbott Libre Duo 10 Day merges both signals into a single dashboard so people can make more informed treatment decisions. The design goal, Abbott said, was to deliver this added layer of protection without increasing the mental or physical burden already carried by people managing diabetes day to day.
Who Can Use the Abbott Libre Duo 10 Day System
Abbott Libre Duo 10 Day is intended for people considered at higher risk of elevated ketones, including those with Type 1 or Type 2 diabetes who use insulin or other glucose-lowering medications such as SGLT2 inhibitors. The system is authorized for people with diabetes ages 2 and older and offers up to 10 days of wear per sensor.
In a wear-duration study cited by Abbott, 84.1% of sensors in the adult population and 68.8% of sensors in the pediatric population lasted the full 10-day cycle when used according to labeling, meaning roughly 16% of adult sensors and 31% of pediatric sensors may not reach the full duration. The system integrates with the latest-generation Libre app currently available in the United States, along with LibreView for health care providers and LibreLinkUp for caregivers monitoring loved ones remotely.
Abbott is also coordinating with automated insulin delivery, or AID, manufacturers so pump systems can connect directly with the new dual sensors. The company expects Abbott Libre Duo 10 Day to work with Beta Bionics’ iLet and Sequel Med Tech’s twiist AID systems by the end of 2026, with Insulet and Tandem devices following in 2027. Abbott and Medtronic’s MiniMed business are separately collaborating on an exclusive integration between Abbott-manufactured dual glucose-ketone sensors and MiniMed smart dosing systems, targeted for 2027.
