EP17.33: Clinical utility of first trimester combined screening for gestational diabetes using a point of care system

To determine the clinical utility of first trimester screening for gestational diabetes (GDM) using maternal serum levels of glycosylated fibronectin (GlyFn), C-peptide (CPEP) and adiponectin (ADIPO) in East Asian women. This is a nested case-control study. Concentration levels of GlyFn, CPEP were measured, using the LumellaTM/Insudex point of care (PoC) system (DiabetOmics, USA) and ADIPO by ELISA (R&D Systems) in postprandial archived serum taken at 11-13 weeks gestation of 553 singleton pregnancies,156 with GDM and 397 non-GDM. GDM was diagnosed at 24-28 weeks using 75g OGTT based on the IADPSG criteria. Concentration levels were transformed to multiples of expected median (MoM) to adjust for fixed and random maternal and pregnancy factors. Individual patient specific a priori risks and posteriori risks for GDM were estimated using the population incidence of GDM adjusted for fixed risk factors using likelihood ratios and multivariate Gaussian models. Screening performance was assessed using area under receiver operating curves (AUC) and determining detection rates (DRs) at fixed 10% false positive rate. Difference in AUC was assessed using Delong Test. Compared to non-GDM pregnancies those with GDM had significantly (p < 0.0001 for all) increased levels of GlyfN-MoM (1.00 vs 1.11), log10CPEP-MoM (0.00 vs 0.10) and reduced log10ADIP-MoM (0.00 vs -0.09). AUCs and DR when screening by a priori risk based on maternal factors (MF) alone were respectively 0.74 and 39%. Screening using GlyFN, CPEP and ADIPO plus MF significantly (p < 0.01 for all) increased AUC compared to screening by MF alone. AUCs and DR when combining GlyFN, CPEP and ADIPO with MF were respectively 0.79 and 50%, 0.76 and 41%, and 0.77 and 42%. Combining GlyFn measured using a PoC test with MF resulted in the greatest increase in GDM screening performance at 11-13 weeks. Further prospective studies are needed.