The U.S. Food and Drug Administration (FDA) has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged 2 years and older with diabetes. This device is the first in the U.S. to continuously monitor ketone levels and the first globally to monitor both ketones and blood sugar (glucose) together.
Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health, stated, "Today’s authorization is a breakthrough for the safety of children and adults living with diabetes. Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency."
According to the Centers for Disease Control and Prevention (CDC), approximately 40.1 million Americans are living with diabetes, which necessitates careful monitoring of blood sugar levels. Among the estimated 2.1 million Americans with type 1 diabetes, monitoring blood sugar is only part of the necessary care. Excessive ketone production can lead to diabetic ketoacidosis (DKA), a serious and potentially life-threatening condition.
The Libre Duo 10 Day device continuously measures both ketone and glucose levels in interstitial fluid every minute, providing real-time data to users via a compatible smartphone. The device can send automatic alerts if ketone levels reach concerning thresholds, assisting patients and caregivers in recognizing rising ketones before DKA develops into a medical emergency. The interpretation of ketone information should always consider glucose readings and symptoms.
The FDA's authorization was based on a thorough review of clinical and performance data submitted by Abbott Diabetes Care, the device sponsor. The clinical program included data from six studies involving over 600 participants aged 2 years and older, which evaluated the device's accuracy in monitoring ketone and glucose levels. Results indicated that the device accurately tracked significant differences in ketone levels throughout its 10-day wear period, including the identification of elevated ketone levels prior to the onset of DKA.
This authorization aligns with the FDA’s Home as a Health Care Hub Initiative, which aims to promote the development of innovative, patient-centered devices that integrate into daily life. Prior to authorization, the FDA had granted Breakthrough Device designation for the Libre Duo 10 Day system, intended to expedite the development and review of devices that improve treatment or diagnosis of serious health conditions.
The FDA granted marketing authorization for the Libre Duo 10 Day through the De Novo premarket review pathway, which is used for low- to moderate-risk devices of a new type. The FDA is also establishing special controls related to labeling and performance testing to ensure safety and effectiveness.
The FDA, part of the U.S. Department of Health and Human Services, is responsible for protecting public health by ensuring the safety and effectiveness of medical devices, drugs, vaccines, and other biological products.