Abbott Receives FDA Authorization for World’s First Dual Glucose-Ketone Biowearable for Diabetes
Abbott has announced the U.S. Food and Drug Administration (FDA) authorization of its Libre Duo 10 Day system, the world’s first dual glucose-ketone sensing technology, which is expected to launch in the United States later this year. The biowearable is designed to alert people living with diabetes to rising ketones that can lead to diabetic ketoacidosis (DKA), a serious health complication, while also delivering real-time visibility into glucose levels needed for daily diabetes management. Ketone monitoring occurs in the background, avoiding additional mental or physical burden for users. The system received De Novo authorization after securing breakthrough device designation from the FDA and is the first to meet both the iCGM and new iCGK standards.
DKA is the most common hyperglycemic emergency for people with diabetes, with hospital admissions increasing 55% over the past decade. DKA can develop quickly when the body lacks sufficient insulin and begins breaking down fat for energy, causing ketone levels to rise to dangerous levels. While clinical guidance recommends ketone testing during illness or periods of elevated glucose, most people do not have access to a blood ketone meter at home, and early signs of rising ketones are often mistaken for common infections, delaying treatment.
Libre Duo 10 Day continuously monitors both glucose and ketone levels. Unlike blood or urine ketone tests that provide only a single point-in-time reading, the sensor continuously tracks ketones and is designed to alert users when levels are rising. The system offers up to 10 days of wear and is intended for people with diabetes ages 2 and older. It uses the latest-generation Libre app and will integrate with the broader Libre digital health ecosystem, including LibreView for healthcare providers and LibreLinkUp for caregivers.
Jennifer Sherr, M.D., Ph.D., pediatric endocrinologist at Yale School of Medicine, said as a physician, she sees how quickly DKA can develop and how often early warning signs or opportunities to measure ketones are missed. Sherr noted that Abbott’s dual glucose-ketone system is meaningful because ketone data is collected in the background, helping provide earlier awareness of rising ketone levels.
Chris Scoggins, Executive Vice President of Abbott’s diabetes care business, said if glucose is the speedometer, ketones are like the check engine light — providing an alert that something may need attention. Scoggins noted that 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.
Abbott is working with leading pump companies to enable automated insulin delivery 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 systems by the end of 2026 and with Insulet and Tandem devices in 2027. Abbott and MiniMed are collaborating on an exclusive integration between Abbott-manufactured dual glucose-ketone sensors and MiniMed smart dosing systems, expected in 2027.
Aaron J. Kowalski, Ph.D., Chief Executive Officer of Breakthrough T1D, said in his role with the organization, and as someone who has lived with Type 1 diabetes for decades, he understands the serious risk of DKA and how challenging it can be to identify and monitor elevated ketone levels. Kowalski noted that new technology like Abbott’s dual glucose-ketone system has the potential to change that reality by giving people early and actionable information that can help identify and prevent dangerous complications, adding that Breakthrough T1D is excited the diabetes community will have this option available.
