ABBOTT PARK, Ill., August 25, 2026

Abbott announced that the U.S. Food and Drug Administration (FDA) has authorized Libre Duo 10 Day, the company’s dual glucose-ketone sensing biowearable designed to continuously monitor glucose while also detecting rising ketone levels that can contribute to diabetic ketoacidosis (DKA). The technology is designed to address an important gap in diabetes management by providing continuous ketone monitoring alongside glucose data without requiring users to perform separate point-in-time blood or urine ketone tests. Abbott said Libre Duo 10 Day is the world’s first dual glucose-ketone sensing technology and plans to launch the system in the United States later in 2026.

FDA Authorization Establishes New Ketone Monitoring Standard

Libre Duo 10 Day received FDA De Novo authorization after previously receiving Breakthrough Device designation. The system is the first technology to meet the FDA’s integrated continuous glucose monitoring (iCGM) standard as well as the newly established integrated continuous glucose and ketone monitoring (iCGK) standard. The authorization represents a significant development in diabetes monitoring technology, bringing continuous ketone sensing into a wearable format. Unlike conventional blood or urine ketone tests that provide measurements at individual points in time, Libre Duo 10 Day is designed to monitor ketone levels continuously in the background and provide alerts when levels rise. Abbott’s approach is intended to provide additional health information that may help people recognize potential DKA risk earlier.

Libre Duo Combines Glucose and Ketone Data

The Libre Duo 10 Day system combines continuous glucose monitoring with continuous ketone sensing in a single wearable platform. The device is designed for people with diabetes aged 2 years and older, with up to 10 days of wear, and integrates with Abbott’s latest-generation Libre app in the United States. The technology is particularly relevant for people who may be at higher risk of elevated ketones, including individuals with Type 1 or Type 2 diabetes who use insulin or certain glucose-lowering medicines. Abbott said the system is designed to provide ketone information without adding the routine burden associated with separate ketone testing. The company also plans to integrate the technology into the broader Libre digital health ecosystem, including LibreView for healthcare providers and LibreLinkUp for caregivers.

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Abbott Advances Connected Diabetes Care

The FDA authorization also expands Abbott’s strategy around connected diabetes care and automated insulin delivery (AID). Abbott is working with leading insulin pump manufacturers to enable Libre Duo 10 Day to connect with AID systems. The company expects compatibility with Beta Bionics’ iLet and Sequel Med Tech’s twiist systems by the end of 2026, followed by planned integration with devices from Insulet and Tandem in 2027. Abbott is also collaborating with MiniMed on an exclusive integration between Abbott-manufactured dual glucose-ketone sensors and MiniMed smart dosing systems, expected in 2027. With the new FDA authorization, Abbott is expanding beyond glucose-only monitoring toward a broader biowearable platform capable of tracking multiple metabolic signals, potentially giving patients and healthcare professionals a more comprehensive view of diabetes-related risk.

Source:Abbott, press relese