OBJECTIVE : To investigate the performance of the Roche Accuchek Active glucometer in diagnosing gestational diabetes mellitus (GDM) versus the gold-standard laboratory test.
METHODS : In a prospective cohort observational study at a primary healthcare clinic in Johannesburg, South Africa, pregnant women, excluding known diabetics, were recruited between 2013 and 2016. A 75-g 2-hour oral glucose tolerance test (OGTT) was scheduled at 24–28 gestational weeks. Glucose was measured in venous blood (laboratory) and capillary blood (glucometer). GDM was diagnosed via FIGO criteria. Diagnostic accuracy was evaluated by calculating the sensitivity, specificity, and coefficient of variance (CV) of the glucometer test, and by Bland-Altman plots.
RESULTS : Data from 529 women were analyzed. Of these, 141 (26.7%) and 79 (14.9%) were diagnosed with GDM by laboratory and glucometer measurements, respectively. The CV of the glucometer ranged from 15% to 17%. Bland-Altman plots showed a positive bias of the glucometer results at 0 hours, but a negative bias at 1 and 2 hours of the OGTT. The sensitivity and specificity of the glucometer for the diagnosis of GDM were 27.0% and 89.4%, respectively.
CONCLUSION : Use of the Roche Accuchek Active glucometer for the diagnosis of GDM cannot be recommended.