Comparison of point-of-care-testing glucose meters with standard laboratory measurement of the 50g-glucose-challenge test (GCT) during pregnancy

Abstract

Objectives Although glucose meters are well-established instruments for self-monitoring blood glucose levels, diagnostic and screening procedures should be performed using standard laboratory methods. In addition to standard laboratory methods, HemoCue ® is authorized for screening and diagnostic purposes in Germany. The rapid development of other glucose meters makes it necessary to re-evaluate this recommendation. Our objective was to test the usefulness of glucose meters in screening pregnant patients for gestational diabetes. Methods The 50-g glucose challenge test was administered to one hundred and ninety-three pregnant patients whose blood glucose levels were then simultaneously measured with five portable meters and the HemoCue ®. The results were compared to our standard method (Hexokinase). A cut-off of 7.8 mmol/L was used and sensitivity, specificity, accuracy, the Youden index, and the Kappa index were calculated. The tests were performed by well-trained personnel (C.D. and U.S.). Results 1212 measurements were performed on 193 patients. All glucose meters showed a very good correlation (r > 0.90). None of the measurements showed an extreme deviation necessitating the error grid analysis. The GlucoTouch ® (5.93% ± 7.4) and the HemoCue ® (−9.04% ± 5.9) showed a mean deviation greater than 5%. None of the meters had a mean deviation greater than 10%. The accuracy fluctuated between 0.85 and 0.94. The Kappa index was between 66 to 85. In our clinical trial, the Accu-Chek ®, Glucotouch ®, OneTouch ®, and Precision ® demonstrated greater accuracy and a higher Kappa index than the HemoCue ®. Conclusions Our data showed good concordance in statistical and clinical parameters for most of the six glucose meters. The HemoCue ®, recommended as a standard method in several countries, did not show better concordance than most of the tested glucose meters. When used by well-trained personnel, the accuracy of the Accu-Chek ®, Glucotouch ®, One-Touch ®, and Precision ® was acceptable for use in gestational diabetes screening.