Investigation of the Agreement between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements

Abstract

Purpose: Blood glucose measurement is of great importance in preventing complications and reducing mortality and morbidity for several diseases. Glucometers are used by any healthcare professionals. We conducted this study to show the compatibility between glucometers and autoanalyzers as a basis for hospital procurement. Materials and Methods: Fourty seven venous samples were used. Correlation, Passing Bablok regression analysis, and Bland-Altman difference plot were used to evaluate the results (glucometers and autoanalyzer). Clarke Error Grid analysis was used to assess the clinical agreement (p<0.05). Results: The correlation coefficient for G1 was 0.9294 (p<0.001; 95% CI: 0.8761-0.9603) and 0.9473 (p<0.001; 95% CI: 0.9069-0.9705) for G2. Regression equations were G1 y=1.1235x+3.4662 G2 y=0.8846x+10.0076. In Clarke Error Grid analysis, the criterion of 99% of the data being in zone A or B was met for both glucometers. Conclusion: According to the relevant document, based on the result obtained with the reference method as the target value, 95% of all results less than 100 mg/dl should be within ±12 mg/dl of the target value. 95% of all results above 100 mg/dl should be within ±12.5% of the target value. In addition, the ratio of the sum of results less than 75 mg/dl exceeding ±15 mg/dl and results greater than 75 mg/dl exceeding ±20% of the target value to all results should be less than 2%. Glucometers didn’t fully meet the performance targets. We think that glucometer analysis results should be closely monitored and verified after procurement.

Keywords

• glucometer
• hyperglycemia
• point of care testing