The U.S. Food and Drug Administration authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. This authorization, announced August 25, 2026, marks the first U.S. wearable device that continuously monitors ketone levels and the first device worldwide to monitor both ketones and blood sugar (glucose) together in a single wearable.
FDA leadership highlighted the safety implications of continuous ketone monitoring. Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health, stated that real-time ketone information can distinguish early intervention from a life-threatening emergency.
The Libre Duo 10 Day measures ketone and glucose concentrations in the interstitial fluid beneath the skin. It provides continuous measurements every minute throughout a 10-day wear period. Readings are transmitted wirelessly to a compatible smartphone where users can view current values and trend direction for both ketone and glucose levels.
The system is intended for people with diabetes aged 2 years and older. The device can generate automatic alerts when ketone levels meet predefined concerning thresholds. The FDA release notes that ketone information should always be interpreted in the context of concurrent glucose readings and clinical symptoms.
The FDA based its authorization on a comprehensive review of clinical and performance data submitted by the device sponsor. The clinical program comprised six clinical studies that together enrolled more than 600 participants aged 2 years and older. These studies evaluated the accuracy of both ketone and glucose monitoring functionality across a range of ketone and glucose concentrations.
According to the FDA summary, study results demonstrated that the device accurately tracked clinically meaningful differences in ketone levels throughout the 10-day wear period. The clinical data included evidence that the device identified elevated ketone levels prior to the onset of diabetic ketoacidosis (DKA), supporting its intended safety role.
A central safety feature of the Libre Duo 10 Day is its ability to send automatic alerts when ketone levels reach concerning thresholds. By providing continuous ketone trends rather than single point-in-time measurements, the device may help patients and caregivers recognize rising ketones earlier than they could with intermittent testing alone.
The FDA cautioned that ketone values must be interpreted alongside glucose readings and clinical symptoms. The device’s use is intended to augment, not replace, clinical judgment and established DKA management strategies.
Prior to authorization, the FDA granted the Libre Duo 10 Day Breakthrough Device designation, a status designed to expedite development and review of devices that address life-threatening or irreversibly debilitating conditions. The final marketing authorization was granted through the De Novo premarket review pathway, which is used for novel, low- to moderate-risk device types.
As part of the De Novo authorization, the FDA is establishing special controls that set specific requirements for labeling and performance testing. When these special controls are met alongside general controls, the FDA states there is a reasonable assurance of the device’s safety and effectiveness.
The authorization was described as consistent with the FDA’s Home as a Health Care Hub Initiative, which focuses on advancing patient-centered technologies that support care at home. The Libre Duo 10 Day is positioned as a home-friendly device that continuously monitors metabolic markers relevant to diabetes management and acute complication prevention.
The device is intended for people with diabetes aged 2 years and older. It continuously measures ketone and glucose levels in interstitial fluid and relays data to a compatible smartphone, enabling users and caregivers to view current values and trends and receive automated alerts for concerning ketone levels. The FDA emphasizes interpreting ketone readings in conjunction with glucose data and symptoms and implies that the device may facilitate earlier recognition of rising ketones that can precede DKA.
The release does not provide detailed information on specific alert thresholds, smartphone compatibility lists, disposable sensor costs, insurance coverage, or user training; those details were not reported in the source document.
The FDA news release identified Abbott Diabetes Care as the device sponsor and noted that marketing authorization was granted to that sponsor through the De Novo pathway. The announcement included media and consumer contact avenues listed in the release: a media request link and phone number and the FDA consumer contact line.
For broader context, the release references CDC estimates that about 40.1 million Americans live with diabetes and that approximately 2.1 million have type 1 diabetes, conditions for which ketone monitoring may be particularly relevant due to risk of diabetic ketoacidosis.
The FDA’s boilerplate and additional administrative details, such as the agency’s role and links for follow-up, were included in the original release. The document also notes the content was current as of August 25, 2026.