Overview
- The U.S. Food and Drug Administration authorized Abbott’s Libre Duo 10 Day on Tuesday, Aug. 25, 2026, marking the first wearable approved to continuously monitor both ketone and glucose levels.
- The clearance used the De Novo pathway and followed Breakthrough Device designation, with the FDA establishing special controls that define labeling and performance requirements for this new device type.
- Clinical data from six studies that enrolled more than 600 participants showed the sensor tracked clinically meaningful ketone shifts over a 10-day wear period and identified elevated ketones before diabetic ketoacidosis developed.
- The sensor measures ketone and glucose in the fluid under the skin every minute, sends real-time trends and automatic alerts to a smartphone app, and is authorized for people with diabetes aged 2 years and older who may be at higher risk of elevated ketones.
- Abbott plans a U.S. commercial launch later in 2026 and has said it will roll out staged compatibility with automated insulin delivery systems, with some pump integrations targeted for late 2026 and broader links expected in 2027.