engleski

Screening for gestational diabetes with Nova Stat- Strip point-of-care glucose analyser.

Abstract: Universal screening for gestational diabetes (GDM) is currently among the most challenging tasks in prenatal care. Despite complexity and low reproducibility, oral glucose tolerance test (oGTT) with laboratory mesurement of venous plasma glucose (VPG) at fasting, 1 and 2 hours after a 75g glucose load, is still the unavoidable diagnostic procedure for classification of glycaemic status in pregnancy according to the evidence-based consensus diagnostic criteria. However, establishment of simple, reliable and cost-effective alternatives to oGTT for GDM screening is needed in order to facilitate diagnostic procedure and improve patient outcomes. The aim of this study was to assess the utility of fasting capillary plasma glucose (F-CPG), measured by the point-of-care (POC) glucose analyzer, designed and aproved for hospital use (StatStrip Glucose, Nova Biomedical, USA), for the screening of GDM in high-risk population. Pregnant women, previously undiagnosed with diabetes mellitus (DM) but assessed as having high-risk of pregnancy-associated hyperglycaemia, referred to our tertiary-care diabetes clinic, were enrolled in this study. After providing an informed consent, fasting venous and capillary blood samples were taken, followed by a 75g-oGTT with venous blood sampled at 1- and 2-hour after glucose load. Fasting sample collection and testing was carried out within 5 minutes for the reference laboratory- (hexokinase, Olympus AU400, Beckman Coulter, USA) and StatStrip-glucose measurement, respectively. Glycaemic status was classified as either normal, GDM or DM, according to WHO-2013 venous plasma-based criteria. Out of 627 pregnant women included in the study [median age: 30 years (range 18-43)], 458 (73, 1%) were classified as normoglycaemic (NG), 168 (26.8%) were diagnosed with GDM, and 1 (0, 2%) with DM. 138/168 (82, 1%) GDM cases were classified with F-VPG ≥5, 1 mM, either alone, or in combination with 1h- and 2h-PG values. Comparison of ROC- curves revealed AUCs of 0, 845 and 0, 889 for F-CPG and F-VPG, respectively (P<0, 001). Inclusion of the analytical imprecision of StatStrip POCT- glucose analyzer (coefficient of variation: 2, 8%) resulted into 95%CI ranging from 4, 8 (86, 90% sensitivity) - 5, 4 mM (97, 6% specificity) for C-FPG. 270 and 95 women had their C-FPG values below and above the 95%CI range, respectively, while the remaining 262 women (41.8%) had to proceed with oGTT in order to correctly classify their glycaemic status. Our results indicate that C-FPG, as measured by POC-glucose analyzer with high-quality analytical performance, may provide a valuable and reliable tool for the GDM screening in high-risk population.

gestational diabetes; screening; point-of-care glucose analyzer

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