Diagnostic Accuracy of Capillary Blood Glucometer Testing for Gestational Diabetes

Few pregnant women in low-resource settings are screened for gestational diabetes mellitus (GDM) using the gold standard oral glucose tolerance test (OGTT). This study compared capillary blood glucose testing with 2-h plasma glucose measurements obtained using the 75-g OGTT to screen for GDM at primary healthcare clinics in Mexico. Pregnant women who participated in a previous prospective multicenter longitudinal cohort study and who had not been previously diagnosed with diabetes were included. Participants were evaluated using the plasmatic 2-h 75-g OGTT with simultaneous capillary blood glucose measurements using a glucometer. The study endpoint was the comparability of the glucometer results to the gold standard OGTT when collected simultaneously. Sensitivity, specificity, and area under the curve of the glucose measurements obtained for capillary blood compared with venous plasma (gold standard) were calculated to determine diagnostic accuracy. The study included 947 pregnant women who had simultaneous glucose measurements available (blood capillary [glucometer] and venous blood OGTT). Overall, capillary blood glucose testing was very sensitive (89.47%); the specificity was 66.58% and the area under the curve (95% confidence interval) was 0.78 (0.74-0.81). The sensitivity, specificity and area under the curve of each capillary measurement were: 89.47%, 66.58% and 0.78 (0.74-0.82) for the fasting measurement, 91.53%, 93.24% and 0.92 (0.88-0.96) for the one-hour measurement, and 89.80%, 93.32%, 0.91 (0.87-0.95) for the second-hour measurement, respectively. No adverse events were reported. Capillary OGTT is a valid alternative to the gold standard OGTT for screening of GDM in low-resource situations or in situations where there are other limitations to performing the OGTT as part of primary healthcare services.