Clinical Report: FDA authorizes continuous ketone monitor

Overview

The FDA has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, marking it as the first device in the US to continuously monitor both glucose and ketone levels.

Background

Continuous monitoring of glucose and ketone levels is critical for managing diabetes and preventing complications such as diabetic ketoacidosis (DKA). Traditional methods of monitoring ketones have been limited to point-in-time measurements. The introduction of the Libre Duo system offers continuous monitoring and automated alerts for concerning ketone levels.

Data Highlights

Key Findings

• The Libre Duo system measures glucose and ketone levels every minute.
• It provides automated notifications for elevated ketone levels.
• The device was evaluated in six clinical studies with over 600 participants aged 2 years and older.
• Clinical testing showed accurate tracking of clinically meaningful differences in ketone levels.
• The device received Breakthrough Device designation from the FDA.

Clinical Implications

The Libre Duo system offers continuous monitoring and timely alerts for elevated ketone levels.

Conclusion

The authorization of the Libre Duo system enables continuous monitoring of both glucose and ketone levels.

Related Resources & Content

1. US Food and Drug Administration, FDA, 2026 -- FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
2. American Diabetes Association, Diabetes Care, 2026 -- Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes
3. MDSpire News — FDA Expands OTC CGM Access to Children
4. reuters — FDA Approves Two OTC Glucose Monitors
5. Stat News — Are glucose monitors a good thing for 2-year-olds? Experts look at risks, benefits
6. JAMA Network Open — Implementing Continuous Glucose Monitoring Alerts in Clinical Settings—Moving Beyond Efficacy
7. FDA Expands OTC CGM Access to Children
8. FDA Approves Two OTC Glucose Monitors
9. Are glucose monitors a good thing for 2-year-olds? Experts look at risks, benefits
10. FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar | FDA
11. 6. Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes—2026 | Diabetes Care | American Diabetes Association
12. Continuous Ketone Monitoring in Diabetic Ketoacidosis: Prospective Multicenter Method-Comparison and Feasibility Study - PubMed