Abbott has secured U.S. FDA authorization for what it calls the world’s first technology to continuously monitor both glucose and ketones, potentially giving people with diabetes an earlier warning of a dangerous complication.

 

The healthcare giant said that its Libre Duo 10 Day system has received De Novo authorization. The wearable continuously tracks glucose while monitoring rising ketone levels, which can signal the onset of diabetic ketoacidosis (DKA), a potentially life-threatening emergency.

 

Abbott plans to launch the device in the United States later this year.

 

DKA can develop rapidly when the body lacks enough insulin and begins breaking down fat for energy, causing ketones to build up in the blood. The American Diabetes Association warns that the condition can progress within hours and, if untreated, can lead to coma or death.

 

Abbott said hospital admissions for DKA have risen 55% over the past decade, underscoring the need for earlier detection.

 

"As a physician, I see how quickly DKA can develop—and how often early warning signs or opportunities to measure ketones are missed," said Jennifer Sherr, pediatric endocrinologist at Yale School of Medicine. "Abbott's dual glucose-ketone system is meaningful because ketone data is collected in the background, helping provide earlier awareness of rising ketone levels."

 

Unlike conventional blood or urine ketone tests, which provide a single reading, Libre Duo 10 Day continuously monitors ketone levels and is designed to alert users when they are rising.

 

The system is the first to meet the FDA’s standards for both integrated continuous glucose monitoring (iCGM) and the newly established integrated continuous glucose and ketone monitoring (iCGK), Abbott said.

 

"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."

 

The device is designed for people aged 2 and older and can be worn for up to 10 days. It is aimed particularly at people at higher risk of elevated ketones, including those with Type 1 or Type 2 diabetes who use insulin or certain glucose-lowering drugs such as SGLT2 inhibitors.

 

Abbott said the sensor will work with its latest-generation Libre app in the U.S. and connect with the broader Libre digital health ecosystem, including LibreView for healthcare providers and LibreLinkUp for caregivers.

 

The company is also pursuing integrations with major insulin pump manufacturers.

 

Abbott expects Libre Duo 10 Day to work with Beta Bionics' iLet and Sequel Med Tech's twiist automated insulin delivery systems by the end of 2026, followed by integrations with Insulet and Tandem devices in 2027.

 

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

 

"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," said Aaron J, chief executive officer of Breakthrough T1D. 

 

"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. Breakthrough T1D is excited that the diabetes community will have this option available to support their day-to-day management."

 

Abbott said the Libre Duo system also received CE Mark earlier this year.

 

The company, which says its Libre glucose-monitoring technology is used by more than 8 million people across more than 60 countries, plans to make Libre Duo 10 Day available in the U.S. later this year.

 

Abbott cautions that the system may not detect every severe glucose or ketone event and says users should follow the device's labeling and seek medical attention when appropriate.