Variability among five over-the-counter blood glucose monitors

Area of Science:

• Clinical Chemistry
• Medical Devices
• Diabetes Management

Background:

• The American Diabetes Association recommends self-monitoring of blood glucose concentration for diabetes management.
• Variability among common blood glucose monitors necessitates an assessment for standardization.

Purpose of the Study:

• To evaluate the variability among five common blood glucose monitors.
• To determine the need for standardization in blood glucose monitoring devices.

Main Methods:

• Minimized preanalytical and user variability by using a single trained operator and standardized procedures.
• Tested each monitor twice per participant using both aged and fresh test strips.
• Analyzed monitor variability using ANOVA across different concentration ranges and strip lots.

Main Results:

• No statistically significant differences in total or within-strip lot coefficients of variation (CVs) were found among monitors.
• Statistically significant differences in among-strip lot CVs were observed, ranging from 0% to 7.5%.
• The degree of significance for among-strip lot CVs increased with higher blood glucose concentration ranges.
• Over half of paired monitor comparisons showed statistically significant average percent differences, ranging from 5.7% to 32.0%.

Conclusions:

• Blood glucose monitor results exhibit significant variability, leading to poor agreement among devices.
• Standardization of blood glucose monitoring devices is essential to reduce variability.
• Standardization will ultimately improve the quality of patient care in diabetes management.