雅培获FDA批准Libre Duo 10 Day双 glucose-ketone 可穿戴传感器

The FDA has cleared Abbott’s first-of-its-kind bio-wearable sensor that can warn diabetics of increased ketones—a condition that can lead to diabetic ketoacidosis.
The company’s Libre Duo 10 Day system tracks real-time glucose levels in diabetics, which are essential for daily management of the chronic autoimmune disease, while also monitoring for increased ketone levels.
The system, which Abbott first unveiled it was working on in 2022, is for people with diabetes ages 2 and older and can be worn for up to 10 days. The new sensor is expected to become available in the U.S. later this year, the company said.
“If glucose is the speedometer, ketones are like the check engine light—providing an alert that something may need attention,” Chris Scoggins, Abbott’s executive vice president of diabetes care business, said in a statement. “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.”
Diabetic ketoacidosis, also known as DKA, results when there is a shortage of insulin, which triggers the breakdown of fat, rather than glucose, to use as energy. When that occurs, acids called ketones build up in the bloodstream, that if untreated, can lead to DKA, which can result in nausea, pain, confusion, fatigue and even death in severe cases.
The Libre Duo 10 Day targets patients 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 like sodium-glucose cotransporter 2 inhibitors, also known as SGLT2s.
“As a physician, I see how quickly DKA can develop—and how often early warning signs or opportunities to measure ketones are missed,” Jennifer Sherr, a pediatric endocrinologist at Yale School of Medicine, said in a statement. “Abbott's dual glucose-ketone system is meaningful because ketone data is collected in the background, helping provide earlier awareness of rising ketone levels.”
Abbott also reaffirmed its ongoing work to integrate Beta Bionics’ iLet and Sequel Med Tech’s twists AID systems by the end of this year and devices from Insult and Tandem next year.
Abbott’s collaboration with MiniMed to develop an integration between the Abbott-manufactured dual glucose-ketone sensors and MiniMed’s smart dosing systems could debut in 2027, the company said.