FDA authorizes Abbott's wearable to monitor ketone and glucose in diabetes patients

The U.S. Food and Drug Administration has approved Abbott Laboratories' new wearable device, the Libre Duo 10 Day, capable of continuously monitoring both ketone levels and blood sugar. This marks the first time a device has been authorized to track these two crucial health indicators simultaneously. Intended for daily use by individuals aged 2 years and older with diabetes, the biowearable is designed to alert users when ketone levels rise, potentially indicating the onset of a dangerous condition called diabetic ketoacidosis (DKA).

Abbott's device goes beyond previous ketone tests by providing real-time monitoring and trend analysis, displaying data in a continuous stream rather than isolated, one-time measurements. This continuous tracking allows for early detection of rising ketone levels, potentially averting a medical emergency. Chris Scoggins, executive vice president of Abbott's diabetes care business, emphasized the device's role in providing a comprehensive view of both glucose and ketone levels, akin to a check engine light that signals potential issues before they become critical.

Abbott is also collaborating with leading insulin pump manufacturers to facilitate automated insulin delivery systems that can connect with the device's sensors. The company anticipates that the Libre Duo 10 Day will be compatible with systems from Insulet and Tandem by 2027.