FDA authorizes first 2-in-1 wearable of its kind for patients with diabetes
The U.S. Food and Drug Administration (FDA) has authorized the first medical device of its kind, a two-in-one wearable that tracks both glucose and ketone levels to help patients with diabetes avoid serious health complications.
Abbott’s Libre Duo 10 Day monitors glucose like a standard diabetes management device, but it does not stop there. The newly authorized device also monitors the user’s ketone levels, sounding an alarm when they show signs of diabetic ketoacidosis (DKA). DKA can progress quickly, even carrying a risk of death if it goes untreated.
Ketones are typically tracked using blood or urine tests that only provide a temporary look at a person’s levels. This two-in-one device monitors ketones at all times, providing a much clearer picture of the user’s health.
“If glucose is the speedometer, ketones are like the check engine light—providing an alert that something may need attention,” Chris Scoggins, executive vice president of Abbott's 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.”
“As a physician, I see how quickly DKA can develop—and how often early warning signs or opportunities to measure ketones are missed,” added Jennifer Sherr, MD, PhD, a 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.”
The Libre Duo 10 Day is authorized for any individual with type 1 or type 2 diabetes who is two years old or older. Users manage it with Abbott’s Libre smartphone app, and healthcare providers can access it through LibreView.
Abbott previously secured CE mark approval for this technology in May. The company plans on launching it in the United States in the months ahead.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.