Accuracy of five plasma calibrated glucometers to screen for and diagnose gestational diabetes mellitus in a low resource clinic setting

Abstract

Aims: We investigated the clinical and analytic accuracy of five plasma calibrated glucometers, the use of which is advocated by the World Health Organisation and the International Federation of Gynaecology and Obstetrics, to screen for and diagnose gestational diabetes mellitus (GDM) in low resource settings. Methods: 592 consecutive black African women underwent a 75 g oral glucose tolerance test (OGTT) at 24–28 weeks gestation at an urban South African community health clinic. Capillary glucose was measured by one of five glucometer brands, each paired with a routine laboratory hexokinase method of plasma glucose measurement. The laboratory results served as the gold standard reference test for GDM diagnosis. World Health Organisation GDM diagnostic thresholds were applied to glucometer and laboratory results. Results: Glucometer and laboratory determined GDM prevalence was 75/592 (12.7%) and 30/592 (5.1%) with an elevated fasting glucose diagnostic in 64/75 (85%) and 24/30 (80%) of cases respectively. The proportion of glucometer results fulfilling ISO 15197:2013 recommended analytic accuracy at fasting, 60, and 120 min of the OGTT was 92.4%, 49.8% and 61.5%, with Bland Altman method revealing a positive glucometer bias of 0.22 mmol/l (−0.69–1.12 mmol/l), 0.96 mmol/l (−0.65–2.56 mmol/l) and 0.73 mmol/l (−0.73–2.19 mmol/l) respectively. Only three of the glucometer brands evaluated fulfilled ISO 15197:2013 analytic accuracy requirements and this was only achieved at fasting. All glucometers tested were inaccurate at one and two hours of the OGTT. Conclusions: Not all glucometers may be suitable for GDM screening as only three were accurate compared to the reference test and then only at fasting of the OGTT. Importantly, laboratory fasting glucose was diagnostic of GDM in 80% of cases in this study population. Keywords: Gestational diabetes, Screening, primary care, Fasting glucose, Capillary glucose