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Accuracy of a 15-day Factory-Calibrated Continuous Glucose Monitoring System With Improved Sensor Design.

Shridhara Alva¹, Anuj Bhargava², Bruce Bode³

¹Abbott Diabetes Care, Alameda, CA, USA.

Journal of Diabetes Science and Technology

|April 4, 2025

Summary

The FreeStyle Libre 2 Plus and Libre 3 Plus continuous glucose monitoring systems demonstrate high accuracy over 15 days. These systems offer reliable glucose readings for adults and children, reducing vitamin C interference.

Keywords:

FreeStyle Libre 2 accuracy continuous glucose monitoring factory calibration optional alarm

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Area of Science:

Medical Devices
Biomedical Engineering
Endocrinology

Background:

Evaluates the 15-day factory-calibrated continuous glucose monitoring (CGM) sensor in FreeStyle Libre 2 Plus and Libre 3 Plus Systems.
Features an improved sensor design to minimize vitamin C interference, enhancing reliability.

Purpose of the Study:

To assess the accuracy and performance of the FreeStyle Libre 2 Plus and Libre 3 Plus CGM systems.
To validate sensor performance across various age groups and glucose ranges.

Main Methods:

Enrolled 332 participants (2+ years) across seven US sites.
Collected venous and capillary blood for comparator measurements, with glycemic manipulation in older participants.
Calculated performance metrics including percentage of values within ±20 mg/dL or 20% and Mean Absolute Relative Difference (MARD).

Main Results:

Adults and pediatric participants (6-17 years) showed high accuracy: 94.2% and 94.0% within ±20 mg/dL/20% with MARDs of 8.2% and 8.1% respectively, against YSI comparator.
Younger children (2-5 years) achieved 86.6% within ±20 mg/dL/20% with MARD of 11.2% against SMBG.
Excellent performance in hypoglycemia: 97.1% (adults) and 98.0% (pediatrics) within ±15 mg/dL of YSI comparator.

Conclusions:

The FreeStyle Libre 2 Plus and Libre 3 Plus Systems provide accurate glucose results.
The 15-day wear period demonstrates reliable performance across the full glucose measurement range.