Diagnostic Accuracy of Capillary Blood Glucometer Testing for Gestational Diabetes

Diabetes Metab Syndr Obes. 2022 Dec 14:15:3855-3870. doi: 10.2147/DMSO.S389420. eCollection 2022.

Abstract

Purpose: 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.

Patients and methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Mexico; capillary blood glucose; gestational diabetes mellitus; low-resource; oral glucose tolerance test; screening.

Grants and funding

Funding for this study was provided by Global Health Partnerships Eli Lilly and Company. The funder had no role in the study design; collection, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. Carlos Slim Foundation developed the study design, analysis and interpretation of data, and was involved in the writing of the report; the Ministry of Health Guanajuato was involved in the collection of data; the Ministry of Health Hidalgo was involved in the collection of data; and CIMIGEN was involved in the collection of data.