FDA Authorizes First Wearable Device That Monitors Ketone and Glucose Levels

The U.S. Food and Drug Administration (FDA) has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, marking the first wearable device in the U.S. that simultaneously monitors ketone levels and blood sugar (glucose) in a single device. This breakthrough authorization was approved for individuals aged 2 years and older living with diabetes, a condition affecting an estimated 40.1 million Americans, according to the Centers for Disease Control and Prevention.

The FDA's Director of the Center for Devices and Radiological Health, Dr. Michelle Tarver, emphasized the importance of real-time ketone level monitoring for safety. Ketone levels rising can indicate diabetic ketoacidosis (DKA), a life-threatening condition requiring early intervention. Prior to this, people with diabetes, especially those with type 1 diabetes, had to monitor ketones separately, providing only single measurements at specific intervals, which did not indicate trends of ketone levels rising or falling.

The Libre Duo 10 Day device continuously measures both ketone and glucose levels in the fluid beneath the skin every minute, day and night. Readings are transmitted wirelessly to a compatible smartphone, displaying current ketone and glucose levels, as well as trends of these levels. The device can automatically alert users if ketone levels reach a concerning threshold, potentially helping patients and caregivers detect rising ketones before DKA becomes a medical emergency.

The FDA's authorization is based on extensive clinical data from six studies involving over 600 participants, demonstrating the device's accuracy in tracking ketone levels and identifying elevated levels before the onset of DKA.

This authorization aligns with the FDA's Home as a Health Care Hub Initiative, aiming to develop innovative, patient-centered devices that better integrate into daily life. The device received Breakthrough Device designation from the FDA, designed to expedite review for devices providing more effective treatments or diagnoses for serious diseases.

The device was approved through the De Novo premarket review pathway for low- to moderate-risk devices of a new type, alongside the establishment of special controls defining labeling and performance requirements to ensure safety and effectiveness.