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

The U.S. Food and Drug Administration (FDA) has approved Abbott Laboratories' glucose monitor, aptly named Libre Duo 10 Day, on Tuesday. This is the first device to continuously monitor both ketone levels and blood sugar simultaneously. The wearable, designed for individuals aged 2 years and older with diabetes, is intended for a 10-day wear period.

The biowearable is equipped to alert users of rising ketones, which can trigger a serious health condition known as diabetic ketoacidosis (DKA), a potentially life-threatening situation for diabetes patients. Unlike previous ketone tests that offer individual, single-time readings, Abbott's device provides continuous monitoring of both ketone and glucose levels, showcasing real-time trends.

In addition, the device can automatically send alerts, potentially helping patients and caregivers identify escalating ketone levels preceding DKA from becoming a medical emergency. Chris Scoggins, executive vice president of Abbott's diabetes care business, noted that ketones serve as the 'check engine light' akin to a speedometer, signaling potential issues that need attention.

Scoggins emphasized that the device consolidates glucose and ketone levels into a unified dashboard, offering a more comprehensive overview to assist individuals with diabetes in making informed decisions. Abbott is collaborating with leading pump companies to facilitate automated insulin delivery systems to connect with the sensors. The company stated that the device will be compatible with devices from Insulet and Tandem by 2027.