A comparison of statistical techniques to evaluate the performance of the Glucometer Elite blood glucose meter.
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. 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. All evaluation methods showed excellent agreement between the Glucometer Elite and the YSI plasma equivalent values. The Glucometer Elite system provides accurate and clinically valuable information to the diabetic home tester.