FDA Authorizes Abbott's Continuous Glucose and Ketone Wearable Monitor

Federal health regulators have officially cleared a groundbreaking wearable medical sensor capable of simultaneously tracking both blood sugar and ketone levels around the clock. The U.S. Food and Drug Administration granted regulatory marketing authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, developed by Abbott Diabetes Care, for use by adults and children aged two years and older who live with diabetes, as first reported by Hacker News. The decision marks the introduction of the first wearable hardware authorized in the United States for continuous ketone tracking, as well as the first wearable sensor globally to combine continuous ketone and blood glucose monitoring within a single device.

The continuous monitoring capability addresses a key physiological vulnerability for millions of patients, particularly those diagnosed with type 1 diabetes. According to figures compiled by the Centers for Disease Control and Prevention, approximately 40.1 million Americans live with diabetes, including an estimated 2.1 million individuals managing type 1 diabetes. For this subset of patients, monitoring blood sugar alone does not provide a complete clinical picture. When the human body lacks adequate glucose for energy, it begins breaking down fat reserves, producing chemical byproducts called ketones. Excessive ketone accumulation can rapidly cause diabetic ketoacidosis, a severe and potentially fatal medical complication if left unmanaged.

Historically, individuals requiring ketone monitoring had to rely on manual, single-use testing methods that delivered isolated measurements at a single moment in time. These traditional diagnostic tools were unable to indicate whether ketone concentrations were actively rising or falling. The newly authorized Libre Duo system resolves this limitation by sampling fluid located just beneath the skin surface every minute, operating continuously day and night throughout its 10-day wear duration.

The continuous streams of biometric data generated by the sensor are transmitted wirelessly to a user's compatible smartphone. Through the mobile interface, patients and caregivers can view real-time ketone and glucose readings alongside directional trend indicators. Additionally, the device is configured to trigger automated alert notifications whenever ketone measurements cross predetermined safety thresholds. Regulatory guidance emphasizes that ketone measurements provided by the system should consistently be evaluated alongside blood glucose readings and observed physical symptoms to inform clinical decisions.

“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 FDA evaluated the system's performance and safety profiles through the De Novo premarket review pathway, an established regulatory track designed for low- to moderate-risk medical hardware representing a novel device classification. Prior to granting marketing clearance to Abbott Diabetes Care, the regulatory body had granted the Libre Duo system Breakthrough Device designation. This special designation is intended to accelerate the development and administrative review of health technologies designed to diagnose or treat life-threatening or irreversibly debilitating conditions more effectively.

The regulatory clearance was supported by data from a clinical program comprising six separate clinical studies that collectively enrolled more than 600 pediatric and adult participants aged two and older. Trial results confirmed that the Libre Duo device accurately measured clinically significant changes in ketone levels across diverse physiological ranges throughout the 10-day wear period, successfully detecting elevated ketone concentrations before the onset of diabetic ketoacidosis. Concurrently with the De Novo authorization, the FDA established special controls covering labeling and performance testing to ensure safety and efficacy, while noting that the authorization supports the agency's Home as a Health Care Hub Initiative focused on patient-centered home care technologies.