New Drugs and Therapeutics Update: Libre DUO® 10 Day Continuous Dual Glucose Ketone Monitoring System
Prepared by Evan Graber, DO; Edited by Neha Patel, DO
On August 25, 2026, the U.S. Food and Drug Administration (FDA) approved the Libre DUO® 10-Day Continuous Dual Glucose Ketone Monitoring System, the first wearable diabetes device capable of continuously monitoring both glucose and ketone levels. This device is approved for individuals aged 2 years and older. Glucose and ketone measurements are transmitted to the Libre app, which is compatible with both iOS and Android smartphones.1
The first study evaluating a continuous ketone sensor was published in 2021.2 In this proof-of-concept study involving 12 adults, a first-generation subcutaneous ketone sensor demonstrated the ability to measure β-hydroxybutyrate concentrations within 0.3 mmol/L of capillary blood ketone values. These findings established the feasibility of continuous ketone monitoring. Subsequent publications have described the technical development, calibration methods, and performance characteristics of dual glucose-ketone sensing technology.3 Continuous ketone monitoring has the potential to improve early recognition of ketosis since many individuals with type 1 diabetes (T1D) do not routinely check ketone levels during episodes of hyperglycemia or illness; however, data demonstrating reductions in DKA incidence or other clinical outcomes in real-world settings have not yet been published. In addition, because the Libre DUO® system is not yet commercially available, information regarding pricing and insurance coverage has not been released.
References
- FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
- Alva S, Castorino K, Cho H, Ou J. Feasibility of continuous ketone monitoring in subcutaneous tissue using a ketone sensor. J Diabetes Sci Technol 2021;15(4):768–774; doi: 10 .1177/1932296821100818
- Udo Hoss, Shridhara Alva, Heather Pryor, Zoe Welsh, Benjamin Feldman.”Continuous Dual Glucose–Ketone Sensing Technology.” Diabetes Technology & Therapeutics (2025).