Diagnostic approaches in gestational diabetes and impact of ethnicity
Research type
Research Study
Full title
Screening and diagnostic approaches in gestational diabetes (GDM) and the impact of ethnicity on markers of glycaemia in pregnancy
IRAS ID
180588
Contact name
Katharine Hunt
Contact email
Sponsor organisation
King’s College London School of Medicine
Duration of Study in the UK
1 years, 5 months, 28 days
Research summary
Gestational diabetes (GDM) means raised blood glucose found for the first time in pregnancy. GDM is common, particularly in women from minority ethnicities. GDM does not cause any symptoms in the mother. GDM is associated with adverse pregnancy outcomes which can be improved with treatment of GDM. NICE recommend pregnant women with one or more risk factors should have an oral glucose tolerance test (OGTT). The OGTT is performed in a clinic. This is resource-intensive, and some women with GDM may be missed by this risk-factor based approach. Developing more cost-effective and convenient approaches to screening for GDM is a priority.
In this research we will validate a new home-use OGTT system (hOGTT) against the gold standard OGTT in pregnancy. We will also investigate the performance of glycated haemoglobin (HbA1c) in screening for GDM. HbA1c is used for diagnosis of diabetes outside of pregnancy, but is currently not recommended for screening for GDM. In a substudy we will investigate ethnic differences in HbA1c and other glycaemic markers in pregnancy, and the impact of diet.
We will invite pregnant women between 16-34 weeks gestation to participate. The research involves one hospital visit for an OGTT. Participants will have venous blood samples taken fasting and at 1-hour and 2-hours, and at the same times finger-stick blood drops will be tested on the hOGTT device. We will invite women of Black African, Black Caribbean and White European ethnicity to participate in a substudy in which they will have extra blood taken and their diet assessed.
If the hOGTT provides accurate results in pregnancy, using it to perform OGTTs at home would make screening for GDM less expensive and more convenient. Understanding ethnic differences in HbA1c will help determine if HbA1c is a reliable screening tool for GDM in our ethnically diverse local population.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/1494
Date of REC Opinion
10 Nov 2015
REC opinion
Further Information Favourable Opinion