Abbott has received U.S. Food and Drug Administration clearance for its Libre Duo 10 Day sensor, the first system to meet the agency’s integrated continuous glucose and ketone monitoring standard.
The dual sensor provides up to 10 days of continuous use and is indicated for people with type 1 or type 2 diabetes who use insulin or other glucose-lowering medications, including SGLT2 inhibitors. Abbott said the device is designed to alert users to rising ketone levels, which can signal the onset of diabetic ketoacidosis, a severe complication that has contributed to a 55% increase in hospital admissions over the past decade.
The FDA granted the device De Novo authorization after it received breakthrough device designation. The clearance follows Abbott’s earlier CE mark approval for the Libre Duo systems in Europe earlier this year.
In the U.S., Abbott plans to launch the Libre Duo 10 Day later in 2026. The sensor will integrate with Abbott’s next-generation Libre app and the LibreView platform for healthcare professionals, as well as the LibreLinkUp app for caregivers. Abbott is also working with insulin pump manufacturers to enable connectivity with automated insulin delivery systems from Beta Bionics, Sequel Med Tech, Insulet, and Tandem. Beta Bionics and Sequel Med Tech systems are expected to link by the end of 2026, while integration with Insulet and Tandem devices is targeted for 2027.
The device is indicated for individuals aged 2 and older.
