Seven-Year Clinical Surveillance Program Demonstrates Consistent MARD Accuracy Performance of a Blood Glucose Test...

Area of Science:

• Diabetes technology
• Medical device performance evaluation
• Clinical diagnostics

Background:

• Mean Absolute Relative Difference (MARD) is a key metric for glucose monitoring system accuracy.
• This study evaluates the performance of the OneTouch Verio® glucose meter using a large clinical dataset.
• A 7.5-year self-surveillance program collected over 80,000 data points.

Purpose of the Study:

• To assess the long-term accuracy and consistency of the OneTouch Verio® glucose monitoring system.
• To quantify the Mean Absolute Relative Difference (MARD) across various conditions.
• To compare the system's performance against established reference methods.

Main Methods:

• Routinely sampled test strips from manufacturer production batches.
• Clinical accuracy assessment conducted at three clinic sites using fresh capillary blood.
• Comparison of meter system results with a standard laboratory reference instrument.

Main Results:

• The overall MARD for 80,258 data points was 5.05%.
• Consistent MARD values observed across different glucose levels (e.g., 4.81% at ≥100 mg/dL) and years of manufacture (4.67-5.42%).
• Mean bias recorded at 1.28, with a mean absolute difference of 5.60 mg/dL at low glucose levels.

Conclusions:

• The OneTouch Verio® meter demonstrates consistently low MARD, indicating high accuracy and agreement with reference methods.
• Performance remained stable over the 7.5-year surveillance period.
• The system's reliability provides user confidence, especially when using new strip batches, and shows favorable comparison to continuous glucose monitoring (CGM) systems.