Gestational diabetes mellitus (GDM) diagnosed in early pregnancy is a health care challenge because it increases the risk of adverse outcomes. Plasma glycated CD59 (pGCD59) is an emerging biomarker for diabetes and GDM. The aim of this study was to assess the performance of pGCD59 as a biomarker of early GDM and its association with delivering a large for gestational age (LGA) infant.

Study: Blood levels of pGCD59 were measured in samples from 693 women undergoing a 75g, 2-hour oral glucose tolerance test (OGTT) at <20 weeks gestation in the DALI study: the main analyses included 486 subjects who had normal glucose tolerance throughout the pregnancy, 207 who met criteria for GDM at <20 weeks and 77 diagnosed with GDM at pregnancy week 24-28.

Reference tests: 75g, 2-hour OGTT adjudicated based on IADPSG criteria.

Index test: pGCD59 ELISA.

Primary aim: To assess the performance of pGCD59 to identify women with GDM in early pregnancy (GDM<20).

Secondary aim: To assess the association of pGCD59 with LGA and potentially 

others adverse neonatal outcomes linked to GDM.

Mean pGCD59 levels were significantly higher (p-value <0.001) in women with GDM<20 (3.9 ±1.1 SPU) than in those without (2.7 ±0.7 SPU). pGCD59 accurately identified GDM in early pregnancy with an AUC ROC curves of 0.86 (95% CI: 0.83-0.90). One unit increase in maternal pGCD59 level was associated with 36% increased odds of delivering a large for gestational age (LGA) infant (odds ratio for LGA vs non-LGA infant: 1.4; 95%CI: 1.1–1.8; p-value: 0.016). 

Our results indicate that pGCD59 is a simple and accurate biomarker for detection of GDM in early pregnancy and risk assessment of LGA.  

Supplementary material