FDA authorizes first wearable device that monitors ketone and blood sugar levels

The U.S. Food and Drug Administration (FDA) recently granted authorization for the first wearable device that can monitor both ketone and blood sugar (glucose) levels continuously. Known as the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, this innovative device is designed for individuals aged 2 years and older with diabetes.

Michelle Tarver, M.D., Ph.D., Director of the FDA's Center for Devices and Radiological Health, emphasized the significance of this breakthrough, stating that real-time ketone level information can be crucial in preventing life-threatening emergencies like diabetic ketoacidosis (DKA).

Diabetes affects an estimated 40.1 million Americans, and for those with type 1 diabetes, blood sugar monitoring is just one aspect of the condition. The Libre Duo 10 Day addresses a significant gap in diabetes management by providing continuous monitoring of both glucose and ketone levels, which are critical for early detection of DKA.

Traditionally, ketone monitoring required separate tests that only provided a single measurement at a specific time, making it impossible to determine if ketone levels were rising or falling.

The device wirelessly transmits readings to a compatible smartphone, allowing users to monitor their ketone and glucose levels every minute, day and night. It can also send automatic alerts if ketone levels reach a concerning threshold, helping patients and caregivers recognize potential issues before they become emergencies. The FDA's authorization was based on a thorough review of clinical and performance data from six clinical studies involving over 600 participants aged 2 years and older.

These studies demonstrated that the device accurately tracked clinically meaningful differences in ketone levels, including identifying elevated ketones before the onset of DKA.

This authorization aligns with the FDA's Home as a Health Care Hub Initiative, which aims to develop innovative, patient-centered devices that integrate seamlessly into daily life at home. Prior to authorization, the FDA granted Breakthrough Device designation to the Libre Duo 10 Day, indicating its potential to deliver more effective treatments or diagnostics for life-threatening or debilitating conditions.

The device received marketing authorization from Abbott Diabetes Care through the De Novo premarket review pathway, a regulatory route for low- to moderate-risk new devices. The FDA, part of the U.S. Department of Health and Human Services, is committed to protecting public health by ensuring the safety, effectiveness, and security of various products, including drugs, medical devices, and food.