FDA Designates Abbott’s Glucose-Ketone Monitoring System a Breakthrough Device

Abbott has won a Breakthrough Device designation from the FDA for a wearable device that continuously monitors glucose and ketone levels in one sensor.

The device can help diabetes patients who are at risk for developing diabetic ketoacidosis, a life-threatening complication.  

The glucose-ketone sensor, which will be the same size as Abbott’s FreeStyle Libre 3 continuous glucose monitoring (CGM) sensor, will connect to Abbott's digital network, including personal and caregiver mobile apps and cloud-based data management software for remote monitoring by healthcare professionals.

Abbott is conducting clinical studies on the glucose-ketone monitoring system, with pivotal trials scheduled to take place next year, followed by a regulatory submission.