The assessment on the accuracy of the portable blood glucose meters / 中国医学装备

ABSTRACT

Objective:To assess the accuracy of the portable blood glucose meters. Methods:The study design was equivalent clinical trial. The participants were selected according to the inclusion and exclusion criteria from inpatients, outpatients and outpatient volunteers of the department of endocrinology. The fingertip blood glucose was measured by five portable blood glucose meters and compared with vein blood glucose measured by biochemistry. The measurement error was assessed by the mean difference with biochemical results. The correlation coefficient was calculated to test the correlation between fingertip and vein blood glucose. Results:there were 230 cases in total including 86 males and 144females. The average age was (50.6±13.5) years old. There were 73 fasting blood glucose and 157 postprandial blood glucose. The range of biochemical blood glucose value was from 2.19 to 19.95 mmol/L and the averaged biochemical blood glucose concentration was (6.77±2.65) mmol/L. The minimum measurement error was 0.08mmol/L measured by blood glucose meter C. However, there was one meter E whose 95%confidence interval of measurement error exceeds the equivalent interval (-0.83, 0.83) mmol/L range and the difference does not meet the clinical equivalence. The measurement bias was all lower than 95%. Conclusion:The blood glucose meters can be used as the day-to-day monitoring of blood glucose in patients. The accuracy needs to be improved and continuously monitored.