FDA Authorizes First Wearable Dual Glucose-Ketone Sensor
The wearable system sends wireless glucose and ketone alerts to a smartphone app and is approved for people age 2 and older.
- On Tuesday, the U.S. Food and Drug Administration authorized Abbott Laboratories' Libre Duo 10 Day system, the first wearable device that continuously monitors both blood sugar and ketone levels for people aged 2 years and older.
- Rising ketone levels can lead to diabetic ketoacidosis , a life-threatening complication that develops quickly when insulin is insufficient. Previously, patients relied on separate, one-time tests that often missed early warning signs before medical emergencies.
- Six clinical studies involving more than 600 participants validated the device's accuracy in identifying elevated ketones before DKA onset. Operating in the background, the system continuously tracks trends and sends alerts wirelessly to a smartphone app.
- Integrating with the Libre app, the system connects with automated insulin delivery systems. "If glucose is the speedometer, ketones are like the check engine light," said Chris Scoggins, executive vice president of Abbott's diabetes care business.
- Abbott expects Libre Duo 10 Day to work with Beta Bionics' iLet and Sequel Med Tech's twiist systems by year-end, with further integrations for Insulet and Tandem arriving in 2027. The company plans to launch in the United States later this year.
15 Articles
15 Articles
Tracking more than sugar: Why this breakthrough diabetes tech matters
Abbott has received FDA authorisation for Libre Duo 10 Day, a single sensor that continuously tracks glucose and ketones. The device could give people with diabetes earlier warning of rising ketones before diabetic ketoacidosis develops.
FDA authorizes Abbott's wearable to monitor ketone and glucose in ...
FDA Authorizes First Wearable Dual Glucose-Ketone Sensor
(MedPage Today) -- The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose-Ketone Monitoring System for people ages 2 years and older with diabetes, the agency announced Tuesday. As the first wearable device to track both ketones and glucose...
Journal Gazette & Times-Courier
Abbott receives FDA authorization for world's first dual glucose-ketone sensing technology for people with diabetes
Libre Duo 10 Day is a first-of-its-kind, two-in-one biowearable that monitors glucose and helps detect rising ketone levels that can lead to diabetic ketoacidosis (DKA), a serious health condition for people living with diabetesDesigned to seamlessly address a critical gap…
Coverage Details
Bias Distribution
- 73% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
