To provide continuous monitoring of glucose and ketone levels in a single device.
Approach:
Device Overview: The Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System continuously measures glucose and ketone levels at 1-minute intervals.
Data Transmission: Measurements are transmitted wirelessly to a compatible smartphone, displaying current concentrations and trends.
User Notifications: Users receive automated notifications for concerning ketone levels to prevent diabetic ketoacidosis.
Clinical Evaluation: The device's accuracy was assessed in 6 clinical studies involving over 600 participants aged 2 years and older.
Key Findings:
The device accurately tracked clinically meaningful differences in ketone levels over 10 days.
It identified elevated ketone levels prior to the onset of diabetic ketoacidosis.
Interpretation:
The FDA advises interpreting ketone measurements alongside glucose readings and clinical symptoms.
Limitations:
The device is intended for use in conjunction with clinical assessments.
Conclusion:
The Libre Duo 10 Day received Breakthrough Device designation and marketing authorization through the FDA's De Novo pathway.
