Abbott has received authorisation from the US Food and Drug Administration (FDA) for its Libre Duo 10 Day system, described as the world’s first device to monitor both glucose and ketone levels for diabetic patients.
The company plans to introduce the device in the US later this year.
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The Libre Duo 10 Day is a bio-wearable designed to track glucose in real time and monitor for rising ketone levels that can lead to diabetic ketoacidosis (DKA), a serious complication for individuals with diabetes.
The system aims to address challenges in ketone monitoring by offering background measurement, reducing the burden on users.
This device obtained De Novo authorisation following a breakthrough device designation from the FDA.
According to Abbott, it is the first system to meet the agency’s standards for integrated continuous glucose monitoring (iCGM) and integrated continuous glucose and ketone monitoring (iCGK), which set criteria for ongoing ketone measurement in the US.
The Libre Duo 10 Day sensor delivers up to ten days of continuous monitoring, providing ongoing readings instead of the single-point measurements typical of standard blood or urine ketone tests.
Abbott diabetes care business executive vice-president Chris Scoggins said: “If glucose is the speedometer, ketones are like the check engine light, providing an alert that something may need attention.
“Libre Duo 10 Day brings both glucose and ketone levels together in a single dashboard, providing a more complete picture to help people with diabetes make more informed decisions.”
The system is intended for people with diabetes aged two years and older who use insulin or other glucose-lowering medications, such as sodium-glucose cotransporter 2 inhibitors (SGLT2s).
The device will integrate with Abbott’s latest-generation Libre app, LibreView for healthcare providers, and LibreLinkUp for caregivers.
The company is also working with several pump manufacturers to support compatibility with automated insulin delivery systems, including planned integrations with Beta Bionics, Insulet, MiniMed, Sequel Med Tech, and Tandem.
Earlier this month, Abbott and Google Health entered a multi-year collaboration to bring ongoing glucose monitoring and AI-driven health guidance to users of the Google Health app.
