FDA Authorizes Libre Duo 10 Day, World’s First Dual Continuous Glucose-Ketone Monitoring System for People with Diabetes – Abbott
Abbott announced FDA authorization of its Libre Duo 10 Day system, the world’s first dual glucose-ketone sensing technology.
The new biowearable is designed to alert people living with diabetes of rising ketones that can lead to a diabetic ketoacidosis (DKA) emergency, a serious health complication for people with diabetes. Libre Duo 10 Day delivers real-time visibility into glucose levels needed for daily diabetes management while also monitoring rising ketones in the background, avoiding additional mental or physical burden for people with diabetes. Abbott plans to launch Libre Duo 10 Day in the United States later this year.
First-of-its-kind technology
Libre Duo 10 Day received De Novo authorization after securing breakthrough device designation from the FDA through a program designed to help people gain faster access to innovative medical technologies. It’s the first system to meet 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.
Monitoring ketones in the background
DKA is the most common hyperglycemic emergency for people living with diabetes,1,2 and hospital admissions for DKA have increased 55% over the past decade.3 DKA can develop quickly when the body does not have enough insulin and then starts to break down fat for energy, causing ketone levels to rise to potentially dangerous levels in the blood.4 According to the American Diabetes Association, DKA can progress within hours and, if left untreated, can lead to coma or death.4 While clinical guidance is to test ketones during illness or periods of elevated glucose, the majority of people do not have access to a blood ketone meter at home5 and early signs of rising ketones are often mistaken for common infections, resulting in delayed treatment .
“As a physician, I see how quickly DKA can develop—and how often early warning signs or opportunities to measure ketones are missed. Abbott’s dual glucose-ketone system is meaningful because ketone data is collected in the background, helping provide earlier awareness of rising ketone levels.” – Jennifer Sherr, M.D., Ph.D., pediatric endocrinologist at Yale School of Medicine.
