Abbott Laboratories said on Tuesday the U.S. Food and Drug Administration granted De Novo authorization to its Libre Duo 10 Day system, marking the first device to meet the regulator’s new integrated continuous glucose and ketone monitoring standard.
The dual-sensor device tracks both glucose and ketone levels continuously for up to 10 days and is designed to alert users to rising ketones that can precede diabetic ketoacidosis. It is intended for people with Type 1 or Type 2 diabetes aged two and older who use insulin or other glucose-lowering medications, including SGLT2 inhibitors.
The FDA clearance follows a breakthrough device designation and comes after Abbott secured CE Mark approval for the Libre Duo systems earlier in 2026. Hospital admissions for diabetic ketoacidosis have risen 55% over the past decade, according to the company.
Abbott plans to launch the Libre Duo 10 Day in the United States later this year. The device is expected to integrate with Beta Bionics’ iLet and Sequel Med Tech’s twiist insulin delivery systems by the end of 2026. Compatibility with Insulet’s Omnipod and Tandem’s t:slim X2 systems is slated for 2027.
The Libre Duo system includes the sensor, the Libre app, LibreView, and LibreLinkUp, forming part of Abbott’s expanding diabetes management ecosystem.
