The FDA authorized Abbott’s Libre Duo 10 Day system, the first wearable sensor to monitor glucose and ketone levels simultaneously. This biowearable is approved for individuals with diabetes aged two and older to help prevent diabetic ketoacidosis.
The system received a Breakthrough Device designation and sends real-time alerts to smartphones when ketone levels rise. It is the first device to meet the FDA’s new integrated continuous glucose and ketone monitoring (iCGK) standard.
Abbott plans to launch the Libre Duo in the U.S. later this year. The device previously received the CE Mark for use in Europe in May 2026.
The company is collaborating with automated insulin delivery manufacturers Beta Bionics and Sequel Med Tech to integrate the technology.