Abbott secures CE mark for Libre Duo glucose-ketone monitors
ABT•Abbott secured CE approval for its Libre Duo and Libre Duo 10 Day monitors, the first systems to sense glucose and ketones every minute for early diabetic ketoacidosis warnings. They will launch in select European markets and are under FDA review for US approval in H2 2026.
1. CE Mark Approval
Abbott has obtained CE mark for its Libre Duo and Libre Duo 10 Day glucose-ketone monitoring systems, making them the first continuous-use devices able to measure both analytes.
2. Device Features and Functionality
The Libre Duo models measure glucose and ketone levels every minute and integrate data into Abbott’s digital health ecosystem, offering early warnings for DKA and wear durations of up to 15 days for adults and ten days for users aged two and older.
3. Launch Timeline and Regulatory Path
Abbott plans to launch both systems later this year in select European markets, and both devices are under FDA review with US approval anticipated in the second half of 2026.
4. Strategic Implications
Approval of the Libre Duo line expands Abbott’s leadership in the CGM market, enhances its digital health platform, and could drive increased revenue from diabetes care solutions.
