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A comparison of statistical techniques to evaluate the performance of the Glucometer Elite blood glucose meter
B Harrison1, R Markes, P Bradley
1Bayer Corporation, Diagnostics Division, Elkhart, IN 46514, USA.
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.