Abbott has received U.S. Food and Drug Administration authorization for Libre Duo 10 Day, a biowearable that continuously monitors both glucose and ketone levels in people with diabetes. Abbott plans to launch the system in the U.S. later in 2026.
Libre Duo 10 Day received De Novo authorization after previously receiving FDA breakthrough device designation. It is the first system to meet both the agency’s integrated continuous glucose monitoring standard and its new integrated continuous glucose and ketone monitoring standard.
The device is intended to address the risk of diabetic ketoacidosis (DKA), which can occur when insufficient insulin causes the body to break down fat for energy, increasing blood ketone levels. DKA can progress within hours and may result in serious complications. Hospital admissions for DKA have increased 55% over the past decade, according to data cited by Abbott.
Unlike blood or urine ketone tests that provide individual readings, Libre Duo continuously tracks ketones in the background while simultaneously providing glucose measurements. The sensor is designed to alert users when ketone levels are rising.
“If glucose is the speedometer, ketones are like the check engine light—providing an alert that something may need attention,” said Chris Scoggins, executive vice president of Abbott's diabetes care business. “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.”
Libre Duo provides up to 10 days of wear and is intended for people aged two years and older with diabetes, including people using insulin or glucose-lowering medicines such as SGLT2 inhibitors. It operates through Abbott’s latest-generation Libre app and will connect with LibreView for healthcare providers and LibreLinkUp for caregivers.
Abbott is also working to integrate the sensor with automated insulin delivery systems. Compatibility with Beta Bionics’ iLet and Sequel Med Tech’s twiist systems is expected by the end of 2026, followed by Insulet and Tandem devices in 2027. Abbott is separately collaborating with MiniMed on integration with its smart dosing systems, also expected in 2027.
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