A comparison of statistical techniques to evaluate the performance of the glucometer elite® blood glucose meter

Objectives: The objective of the study was to measure the performance of the Glucometer Elite®, a technique-independent device for self-monitoring of capillary blood glucose. Several potential sources of error were incorporated into the study, including variability between lots, the age of a lot, variability between subjects, and variability between strips. Design and Methods: The Glucometer Elite® was tested using capillary samples from 86 individuals. Duplicate readings with each of 8 sensor lots were done for each participant. Glucometer Elite® readings were compared to YSI capillary plasma equivalent values, and the data was evaluated using a variety of both technical and clinical analysis methods. Results: All evaluation methods showed excellent agreement between the Glucometer Elite® and the YSI plasma equivalent values. Conclusion: The Glucometer Elite® system provides accurate and clinically valuable information to the diabetic home tester.