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Context: 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., Objectives: To assess the performance of pGCD59 to identify women with GDM in early pregnancy (GDM < 20) and assess the association of pGCD59 with LGA and potentially others adverse neonatal outcomes linked to GDM., Methods: Blood levels of pGCD59 were measured in samples from 693 obese women (body mass index > 29) undergoing a 75-g, 2-hour oral glucose tolerance test (OGTT) at <20 weeks' gestation in the Vitamin D and Lifestyle Intervention 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 weeks 24 through 28. Reference tests were 75-g, 2-hour OGTT adjudicated based on International Association of Diabetes and Pregnancy Study Group criteria. The index test was a pGCD59 ELISA., Results: Mean pGCD59 levels were significantly higher (P < 0.001) in women with GDM < 20 (3.9 ± 1.1 standard peptide units [SPU]) than in those without (2.7 ± 0.7 SPU). pGCD59 accurately identified GDM in early pregnancy with an area under the curve receiver operating characteristic curves of 0.86 (95% confidence interval [CI], 0.83-0.90). One-unit increase in maternal pGCD59 level was associated with 36% increased odds of delivering an LGA infant (odds ratio for LGA vs non-LGA infant: 1.4; 95% CI, 1.1-1.8; P = 0.016)., Conclusion: Our results indicate that pGCD59 is a simple and accurate biomarker for detection of GDM in early pregnancy and risk assessment of LGA., (© Endocrine Society 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aims: To assess if pregnancy outcomes for women with GDM treated with insulin (GDM-I) are comparable to outcomes for women with GDM treated with medical nutritional therapy (MNT) (GDM-M)., Materials and Methods: This retrospective cohort study included 752 women with GDM-I and 567 women with GDM-M. Maternal and foetal outcomes were examined., Results: Women with GDM-I had a greater risk of polyhydramnios (aOR 2.33, 95%CI 1.31-4.14) and were more likely to deliver by caesarean section (CS) (aOR 1.67, 95%CI 1.25-2.23). Their offspring had higher rates of macrosomia (22.2% vs 12.7%; p < .01), large for gestational age (LGA) (19.7% vs 12.5%; p < .01) and were more likely to require neonatal intensive care unit (NICU) admission (aOR 4.88, 95%CI 3.54-6.73). There was no difference between the groups in rates of pre-eclampsia (PET), pregnancy-induced hypertension (PIH), infant mortality, congenital malformations, neonatal hypoglycaemia, prematurity and rates of small for gestational age (SGA)., Conclusions: GDM-I and GDM-M mothers have similar rates of maternal medical morbidities. Despite this, the rate of delivery by CS remains greater, possibly driven by physician choice for elective intervention in the GDM-I group. Despite insulin therapy, offspring of GDM-I mothers experience higher rates of macrosomia, LGA and NICU admissions. This may be related to the higher baseline risk profile in GDM-I women, to sub-optimal glycaemic control, excessive gestational weight gain (GWG) or higher baseline BMI of the mother. Addressing baseline maternal BMI, limiting excessive GWG and tightening glycaemic control in GDM-I women may translate to better pregnancy outcomes., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Introduction: Approximately 40% of women with gestational diabetes mellitus (GDM) diagnosed using International Association of the Diabetes and Pregnancy Study Group (IADPSG) criteria require insulin therapy., Objective: We assessed whether the outcomes for women with GDM treated with insulin are comparable to women with normal glucose tolerance (NGT)., Materials and Methods: This retrospective cohort study included 752 women with insulin-treated GDM and 2496 women with NGT during pregnancy. Maternal and fetal outcomes were examined., Results: Infants of women with insulin-treated GDM had rates of macrosomia [adjusted odds ratio (aOR), 1.19; 95% confidence interval (CI), 0.87 to 1.63; P = 0.26], large for gestational age (LGA) (aOR, 1.07; 95% CI, 0.77 to 1.47; P = 0.67), and small for gestational age (SGA) (aOR, 0.70; 95% CI, 0.38 to 1.38; P = 0.26) similar to women with NGT. They were more likely to be hypoglycemic at birth (aOR, 6.85; 95% CI, 2.31 to 20.28; P < 0.01) and to require neonatal intensive care unit care (NICU) (aOR, 12.09; 95% CI, 8.72 to 16.76; P < 0.01), predominantly for nonmedical reasons. Maternal rates of hypertensive disorders (preeclampsia: aOR, 0.64; 95% CI, 0.34 to 1.12; P = 0.17; pregnancy-induced hypertension: aOR, 1.11; 95% CI, 0.74 to 1.66; P = 0.60) and hemorrhage (ante partum hemorrhage: aOR, 0.56; 95% CI, 0.19 to 1.58; P = 0.27; postpartum hemorrhage: aOR, 1.17; 95% CI, 0.68 to 2.03; P = 0.55) were similar between groups, but the risk of polyhydramnios was increased in the GDM cohort (aOR, 7.75; 95% CI, 3.96 to 15.16; P < 0.01)., Conclusions: Insulin treatment of IADPSG-diagnosed GDM results in rates of macrosomia, LGA, SGA, and maternal hypertensive disorders similar to those of women with NGT. Although NICU admissions are greater in the GDM cohort, they are primarily for nonmedical reasons. Neonatal hypoglycemia and polyhydramnios remain greater among women with insulin-treated GDM., (Copyright © 2017 by the Endocrine Society)

The aim of this study was to evaluate the ability of second trimester plasma glycated CD59 (pGCD59), a novel biomarker, to predict the results of the 2 h 75 g oral glucose tolerance test at 24–28 weeks of gestation, employing the 2013 World Health Organisation criteria. This was a prospective study of 378 pregnant women. The ability of pGCD59 to predict gestational diabetes (GDM) was assessed using adjusted ROC curves for maternal age, BMI, maternal ethnicity, parity, previous GDM, and family history of diabetes. The pGCD59 levels were significantly higher in women with GDM compared to women with normal glucose tolerance (p = 0.003). The pGCD59 generated an adjusted AUC for identifying GDM cases of 0.65 (95%CI: 0.58–0.71, p < 0.001). The pGCD59 predicted GDM status diagnosed by a fasting glucose value of 5.1 mmol/L with an adjusted AUC of 0.74 (95%CI: 0.65–0.81, p < 0.001). Analysis of BMI subgroups determined that pGCD59 generated the highest AUC in the 35 kg/m2 ≤ BMI < 40 kg/m2 (AUC: 0.84 95%CI: 0.69–0.98) and BMI ≥ 40 kg/m2 (AUC: 0.96 95%CI: 0.86–0.99) categories. This study found that second trimester pGCD59 is a fair predictor of GDM status diagnosed by elevated fasting glucose independent of BMI and an excellent predictor of GDM in subjects with a very high BMI. [ABSTRACT FROM AUTHOR]

Background: Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes including increased rates of caesarean section birth, macrosomia, congenital malformation, prematurity, admission to the neonatal intensive care unit and stillbirth. As a result, there has been an increase in interventions to improve outcomes in both mother and infant. To date, meaningful comparisons between these studies are limited due to heterogeneity in outcome selection and reporting. The aim of this study is to develop a core outcome set (COS) for randomised controlled trials evaluating the effectiveness of interventions for the treatment of pregnant women with PGDM.Methods: The study consists of three steps. The first step is a systematic review of the literature to assess outcomes reported in randomised controlled trials assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. The second step is a three round, online Delphi survey to prioritise these outcomes. In this step, stakeholders (including women with PGDM, healthcare workers, researchers and policymakers) will be asked to rank the importance of outcomes for inclusion in the COS using a 9-point Likert type scale. Outcomes that meet the inclusion criteria after completion of the Delphi surveys will be brought to the consensus meeting. The consensus meeting will be the third and final step, where the COS will be finalised. The consensus meeting will include members from each stakeholder group.Discussion: This paper describes the process used to develop a COS for the reporting of studies evaluating the effectiveness of interventions in pregnant women with PGDM. The COS will enable greater comparison between and information synthesis across RCTs in the treatment of PGDM. In addition, this COS will also help improve trial reporting and minimise research waste by prioritising the collection and reporting of outcomes that matter to all relevant stakeholder groups.Trial Registration: This COS has been registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative ( http://www.comet-initiative.org/studies/details/1425 ) on the 4th of November 2019. The systematic review component of this study has also been registered with the International Prospective Register of Systematic Reviews (PROSPERO) ( https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173549 ). [ABSTRACT FROM AUTHOR]