Abbott has received US Food and Drug Administration (FDA) authorization for its Libre Duo 10 Day system, which it claims is the world’s first dual glucose and ketone sensing technology.
The new biowearable is designed to alert people living with diabetes to rising ketone levels that can lead to diabetic ketoacidosis (DKA), a serious and potentially life-threatening complication of diabetes.
Libre Duo 10 Day provides real-time glucose readings for daily diabetes management while continuously monitoring ketone levels in the background. Unlike blood or urine ketone tests, which provide only a single point-in-time reading, the sensor continuously tracks ketones.
“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,” said Chris Scoggins, executive vice president of Abbott’s diabetes care business.
The biowearable is intended for people who may be at higher risk of elevated ketone levels, including those with Type 1 or Type 2 diabetes who use insulin or other glucose-lowering medications, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Libre Duo 10 Day can be worn for up to 10 days and is designed for diabetes patients aged 2 years and older. The system uses Abbott’s latest-generation Libre app available in the US and will integrate with the broader Libre digital health ecosystem, including LibreView for healthcare providers and LibreLinkUp for caregivers.
Abbott plans to launch Libre Duo 10 Day in the United States later this year.
First-of-its-kind technology
The system received De Novo authorization from the FDA after being granted Breakthrough Device Designation.
Abbott said Libre Duo 10 Day is the first system to meet the FDA’s integrated continuous glucose monitoring (iCGM) standard as well as the new integrated continuous glucose and ketone monitoring (iCGK) standard, which establishes a benchmark for continuous ketone monitoring in the US.
The company is also working with insulin pump companies to enable automated insulin delivery (AID) systems to connect with the sensors. The company expects Libre Duo 10 Day to work with Beta Bionics’ iLet and Sequel Med Tech’s twiist AID systems by the end of this year, followed by integration with devices from Insulet and Tandem in 2027.
Abbott and MiniMed are collaborating on an exclusive integration between Abbott-manufactured dual glucose-ketone sensors and MiniMed smart dosing systems, which is expected in 2027.
Earlier this year, Abbott received the CE Mark for its Libre Duo systems.
Diabetic ketoacidosis
Diabetic ketoacidosis occurs when the body does not have enough insulin and begins breaking down fat for energy, causing ketone levels to rise to potentially dangerous levels in the blood.
Abbott noted that hospital admissions for DKA have increased 55% over the past decade.
According to the American Diabetes Association, diabetic ketoacidosis can progress within hours and, if left untreated, can lead to coma or death.
Current clinical guidance recommends ketone testing during illness or periods of elevated blood glucose. However, Abbott noted that many people do not have access to a blood ketone meter at home, and early signs of rising ketones are often mistaken for common infections, resulting in delayed treatment.
