Abbott Receives FDA Authorisation For Dual Glucose And Ketone Monitoring Sensor

Abbott has received US Food and Drug Administration (FDA) authorisation for its Libre Duo 10 Day system, a wearable sensor that continuously monitors both glucose and ketone levels in people with diabetes.

The device is designed to address diabetic ketoacidosis (DKA), a condition that occurs when the body lacks sufficient insulin and begins breaking down fat for energy, causing ketone levels to rise to dangerous levels in the blood. According to the American Diabetes Association, DKA can progress within hours and, if left untreated, can lead to coma or death.

Hospital admissions for DKA have increased 55 per cent over the past decade. Abbott plans to launch the Libre Duo 10 Day in the United States later this year, having already received CE Mark for Libre Duo systems in Europe earlier this year.

How the sensor works

Existing continuous glucose monitors (CGMs) track glucose but do not measure ketones. The Libre Duo 10 Day combines both functions in a single wearable sensor, continuously tracking ketone levels in the background alongside glucose readings.

Unlike blood or urine ketone tests, which provide only a single point-in-time reading, the sensor is designed to continuously track ketones and alert users when levels are rising. The device offers up to 10 days of wear and is intended for people with diabetes ages two and older.

Executive Vice President of Abbott’s Diabetes Care Business, Chris Scoggins, described the approach using an automotive analogy.

“If glucose is the speedometer, ketones are like the check engine light, providing an alert that something may need attention,” Mr Scoggins explained.

“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.”

Addressing a gap in ketone monitoring

The device is positioned to address what Abbott describes as a gap in current diabetes monitoring practices. While clinical guidance recommends testing ketones during illness or periods of elevated glucose, the majority of people do not have access to a blood ketone meter at home. Early signs of rising ketones are often mistaken for common infections, resulting in delayed treatment.

DKA can also develop even when glucose levels appear stable, meaning glucose data alone may not always provide sufficient early warning.

Pediatric Endocrinologist at Yale School of Medicine, Jennifer Sherr, pointed to the clinical significance of background ketone monitoring.

“As a physician, I see how quickly DKA can develop and how often early warning signs or opportunities to measure ketones are missed,” Dr Sherr noted.

“Abbott’s dual glucose-ketone system is meaningful because ketone data is collected in the background, helping provide earlier awareness of rising ketone levels.”

FDA classification and regulatory pathway

The Libre Duo 10 Day received De Novo authorisation after securing breakthrough device designation from the FDA, a programme designed to facilitate faster access to medical technologies that address unmet clinical needs.

The system is the first to meet both the FDA’s integrated continuous glucose monitoring (iCGM) standard and the new integrated continuous glucose and ketone monitoring (iCGK) standard, which establishes a benchmark for continuous ketone monitoring in the United States.

Target population

The device is designed for people who may be at higher risk of elevated ketones, including those with Type 1 or Type 2 diabetes who use insulin or other glucose-lowering medications such as sodium-glucose cotransporter 2 inhibitors (SGLT2s).

Chief Executive Officer of Breakthrough T1D, Aaron J. Kowalski, spoke to the potential impact for the diabetes community.

“In my role with Breakthrough T1D, and as someone who has lived with Type 1 diabetes for decades, I understand the serious risk of diabetic ketoacidosis and how challenging it can be to identify and monitor elevated ketone levels,” Dr Kowalski remarked.

“New technology like Abbott’s dual glucose-ketone system has the potential to change that reality by giving people early and actionable information that can help identify and prevent dangerous complications like DKA.”

Integration with insulin delivery systems

The sensor uses the latest-generation Libre app available in the United States and will integrate with the broader Libre digital health ecosystem, including LibreView for healthcare providers and LibreLinkUp for caregivers.

Abbott is also working with insulin pump manufacturers to enable automated insulin delivery (AID) systems to connect with the sensor. The company expects compatibility with Beta Bionics’ iLet and Sequel Med Tech’s twiist AID systems by the end of this year, and with devices from Insulet and Tandem in 2027.

Abbott and MiniMed are collaborating on an integration between Abbott-manufactured dual glucose-ketone sensors and MiniMed smart dosing systems, expected in 2027.

Wear duration and limitations

Abbott notes that in clinical testing, 84.1 per cent of sensors in the adult population and 68.8 per cent in the paediatric population lasted the full 10 days when used according to labelling. This means approximately 16 per cent of adult sensors and 31 per cent of paediatric sensors may not last the full wear period.

The company also cautions that the Urgent Low Glucose alarm and Urgent High Ketones alarm may not detect all instances of glucose below 55 mg/dL and ketones above 3.0 mmol/L, and should be used together with sensor readings for treatment decisions.

Abbott’s Libre continuous glucose monitoring portfolio is currently used by more than 8 million people in over 60 countries.

For more information, visit abbo.tt/libreduo.

Last Updated on August 26, 2026 by Nick Ross