Abbott’s Libre Duo 10 Day System Receives FDA De Novo Clearance as First Integrated Continuous Glucose-Ketone Monitor

September 6, 2026

Pharmacy Times USA

Overview

Abbott’s Libre Duo 10 Day system has received FDA De Novo clearance, becoming the first integrated continuous glucose-ketone monitoring (iCGK) system in the U.S. and the world’s first wearable device to track both glucose and ketones from a single sensor. This breakthrough technology, targeting diabetic patients aged two and older, aims to prevent critical emergencies like diabetic ketoacidosis (DKA) by continuously detecting rising ketone levels alongside blood glucose. The device is slated for a U.S. launch later this year and is expected to integrate with automated insulin delivery systems.

In Depth

Key Findings

Abbott’s Libre Duo 10 Day system has secured groundbreaking De Novo authorization from the U.S. Food and Drug Administration (FDA). This marks the first integrated continuous glucose-ketone monitoring (iCGK) system in the U.S. that can continuously monitor both glucose and ketone levels using a single wearable sensor. Targeting diabetic patients aged two years and older, this innovation is poised to establish a new standard in diabetes management.

Technical / Clinical Details

The Libre Duo 10 Day system utilizes a small, skin-worn sensor to measure both blood glucose and blood ketone levels in real-time. Unlike traditional continuous glucose monitoring (CGM) devices that only track glucose, this system’s ability to continuously detect rising ketone bodies provides early warning signs for acute complications such as diabetic ketoacidosis (DKA). This allows patients and healthcare providers to intervene promptly. The device can be worn for up to 10 days and wirelessly transmits data to a smartphone or a dedicated reader.

Background & Context

Diabetic ketoacidosis is a life-threatening complication, especially for type 1 diabetes patients, making continuous monitoring of ketone levels crucial for its prevention. Historically, ketone monitoring has relied on manual blood or urine tests, making real-time data provision challenging. Abbott’s new system addresses this gap by tracking both biomarkers in a convenient wearable form factor, easing patient burden and facilitating more comprehensive diabetes management. The device had previously received a “Breakthrough Device” designation, underscoring its innovative nature.

Strategic Significance & Outlook

Abbott plans to launch the Libre Duo 10 Day system in the U.S. later this year, with future plans to integrate it with certain automated insulin delivery systems. This will accelerate the development of “closed-loop systems” that link insulin pumps with CGM data, advancing the automation and personalization of diabetes treatment. This technology is expected to broaden the potential of wearable sensors beyond diabetes management to the monitoring of metabolic diseases in general.

Source: https://www.pharmacytimes.com/view/fda-clears-first-continuous-glucose-ketone-monitor

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