Abbott Laboratories said on Friday the U.S. Food and Drug Administration granted De Novo authorization for its Libre Duo 10 Day system, the first integrated continuous glucose and ketone monitoring device to meet the agency’s new standards.
The system is designed to track both glucose and ketone levels continuously for up to 10 days and is intended for people with Type 1 or Type 2 diabetes aged two and older who use insulin or other glucose-lowering medications. Abbott noted rising hospital admissions for diabetic ketoacidosis, which have increased 55% over the past decade.
The Libre Duo 10 Day has already received the CE Mark for European markets earlier this year. Abbott plans to launch the device in the United States later in 2024.
Integration with insulin pumps is expected to roll out in stages. The system is slated to work with Beta Bionics’ iLet and Sequel Med Tech’s twiist systems by the end of 2024, followed by compatibility with devices from Insulet and Tandem in 2027.
Abbott’s ecosystem includes the Libre app, LibreView and LibreLinkUp for data management and sharing.
