Diagnostic Approaches in Gestational Diabetes and Impact of Ethnicity
Screening and Diagnostic Approaches in Gestational Diabetes (GDM) and the Impact of Ethnicity on Markers of Glycaemia in Pregnancy
3 other identifiers
observational
152
1 country
1
Brief 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. The United Kingdom National Institute for Health and Care Excellence (NICE) recommend pregnant women with one or more risk factors should have a 75g oral glucose tolerance test (OGTT). The OGTT is performed in a clinic with venous plasma glucose measured fasting and at 2 hours. This is resource-intensive, and some women with GDM may be missed by this risk-factor based approach. The International Association of Diabetes and Pregnancy Study Groups (IADPSG 2010) recommends screening all pregnant women with 2-hour, 3 sample (fasting, 1 and 2 hour), 75g OGTT, which is even more resource intensive. Developing more cost-effective and convenient approaches to screening for GDM is a priority. The researchers will validate a new home-use OGTT system (hOGTT), which measures whole blood glucose in capillary blood ('finger-stick' sample), against the gold standard venous plasma glucose in pregnancy. The researchers 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. The researchers will also investigate relationships between glucose measured in different samples (venous versus capillary), different fractions (plasma versus whole blood), and using different methods in pregnancy. In a substudy the researchers will investigate: ethnic differences in HbA1c and other glycaemic markers; the contribution of fasting and postprandial glucose handling, diet and ethnicity on HbA1c; and ethnic differences in insulin responses to 75g OGTT in pregnancy. The researchers 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 samples will be tested. The researchers will invite women of Black African, Black Caribbean and White European ethnicity to participate in a substudy in which participants will have extra blood taken and a diet assessment. 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 and may facilitate universal screening for GDM. Understanding ethnic differences in HbA1c will help determine if HbA1c is a reliable screening tool for GDM in our ethnically diverse local population.
Trial Health
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participants targeted
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedOctober 18, 2018
October 1, 2018
3.2 years
July 11, 2016
October 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of hOGTT venous plasma equivalent glucose (hOGTT-VPEqG) results within ±10% of paired venous plasma glucose measured on a YSI analyser (VPG-YSI) (reference standard).
hOGTT-VPEqG (in mmol/l) is capillary whole blood glucose measured on the home Oral Glucose Tolerance Test (hOGTT) system (the device being evaluated) expressed as venous plasma equivalent glucose (VPEqG). VPG-YSI (in mmol/l) is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements. Paired means samples taken at the same time. Results will be reported for glucose (VPG-YSI) range 4.5-11mmol/L. This was chosen because it encompasses the GDM diagnostic cut-offs for both National Institute for Health and Care Excellence (NICE) 2015 and International Association of Diabetes and Pregnancy Study Groups (IADPSG) 2010 criteria. Samples taken fasting and at 1 hour and 2 hours post 75g oral glucose load will be considered together in this analysis.
Each participant is studied on one occasion between 16-34 weeks gestation.
Secondary Outcomes (14)
Percentage of hOGTT venous plasma equivalent glucose (hOGTT-VPEqG) results within ±15% of paired venous plasma glucose measured on a YSI analyser (VPG-YSI) (reference standard).
Each participant is studied on one occasion between 16-34 weeks gestation.
Percentage of hOGTT venous plasma equivalent glucose (hOGTT-VPEqG) results within ±20% of paired venous plasma glucose measured on a YSI analyser (VPG-YSI) (reference standard).
Each participant is studied on one occasion between 16-34 weeks gestation.
Sensitivity of the hOGTT system for diagnosis of GDM using NICE 2015 criteria (gold standard VPG-YSI).
Each participant is studied on one occasion between 16-34 weeks gestation.
Specificity of the hOGTT system for diagnosis of GDM using NICE 2015 criteria (gold standard VPG-YSI).
Each participant is studied on one occasion between 16-34 weeks gestation.
Sensitivity of the hOGTT system for diagnosis of GDM using IADPSG 2010 criteria (gold standard VPG-YSI).
Each participant is studied on one occasion between 16-34 weeks gestation.
- +9 more secondary outcomes
Other Outcomes (4)
HbA1c in pregnant women of Black (Black African and Black Caribbean) compared to White European ethnicity.
Each participant in this sub-study is studied on one occasion between 16-34 weeks gestation.
Fructosamine in pregnant women of Black (Black African and Black Caribbean) compared to White European ethnicity.
Each participant in this sub-study is studied on one occasion between 16-34 weeks gestation.
The independent factors (out of fasting venous plasma glucose; 1 hour post 75g oral glucose venous plasma glucose; 2 hour post 75g oral glucose venous plasma glucose; dietary carbohydrate content; gestation; or ethnicity) that predict HbA1c in pregnancy.
Each participant in this sub-study is studied on one occasion between 16-34 weeks gestation.
- +1 more other outcomes
Eligibility Criteria
Pregnant women
You may qualify if:
- Main study:
- Pregnant woman at least 18 years of age
- weeks gestation.
- Booked for pregnancy care at a participating centre
- Able to give informed consent to participate
- Substudy:
- Women who are of White European, Black African or Black Caribbean ethnicity.
You may not qualify if:
- Main study
- Unable to give informed consent
- Known pre-pregnancy diabetes
- GDM diagnosed in the current pregnancy
- Substudy
- In addition to main study criteria:
- Women known to have sickle cell anaemia or thalassaemia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Facility, King's College Hospital NHS Foundation Trust
London, SE5 9PJ, United Kingdom
Biospecimen
Serum samples, fasting and at 60 min and 120 min post 75g oral glucose.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katharine F Hunt, MBBS MRCP
King's College Hospital NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2016
First Posted
April 18, 2017
Study Start
March 1, 2016
Primary Completion
April 30, 2019
Last Updated
October 18, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share