Diabetes, GestationalNCT03117543
Diagnostic Approaches in Gestational Diabetes and Impact of Ethnicity
An observational study of Diabetes, Gestational, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes, Gestational
- How many people
- 152 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- Main study:
- Pregnant woman at least 18 years of age
- 16-34 weeks gestation.
- Booked for pregnancy care at a participating centre
- Able to give informed consent to participate
- Substudy:
- In addition to the inclusion criteria of main study:
- Women who are of White European, Black African or Black Caribbean ethnicity.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Research Facility, King's College Hospital NHS Foundation Trust
London, SE5 9PJ
Elka Giemza, rgiemza@nhs.net
About this study
Official title: Screening and Diagnostic Approaches in Gestational Diabetes (GDM) and the Impact of Ethnicity on Markers of Glycaemia in Pregnancy
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.
Read more
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.
- Conditions
- Diabetes, Gestational
- Keywords
- Screening
- Medical subject headings
- Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
VPG-YSI is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements.
NICE (National Institute for Health and Care Excellence) 2015 diagnostic criteria for GDM are: fasting venous plasma glucose ≥ 5.6mmol/L, 2-hour post 75g oral glucose venous plasma glucose ≥ 7.8mmol/L.
Measured: 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).
VPG-YSI is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements.
NICE (National Institute for Health and Care Excellence) 2015 diagnostic criteria for GDM are: fasting venous plasma glucose ≥ 5.6mmol/L, 2-hour post 75g oral glucose venous plasma glucose ≥ 7.8mmol/L.
Measured: 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).
VPG-YSI is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements.
IADPSG (the International Association of Diabetes and Pregnancy Study Groups) 2010 diagnostic criteria for GDM are: 1 or more of fasting venous plasma glucose ≥ 5.1mmol/L, 1-hour post 75g oral glucose venous plasma glucose ≥ 10.0mmol/L or 2-hour post 75g oral glucose venous plasma glucose ≥ 8.5mmol/L.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Specificity of the hOGTT system for diagnosis of GDM using IADPSG 2010 criteria (gold standard VPG-YSI).
VPG-YSI is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements.
IADPSG (the International Association of Diabetes and Pregnancy Study Groups) 2010 diagnostic criteria for GDM are: 1 or more of fasting venous plasma glucose ≥ 5.1mmol/L, 1-hour post 75g oral glucose venous plasma glucose ≥ 10.0mmol/L or 2-hour post 75g oral glucose venous plasma glucose ≥ 8.5mmol/L.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Relationship between whole blood and plasma glucose in capillary blood samples in pregnancy.
In capillary blood samples, glucose will be measured in both whole blood and plasma on the YSI analyser. The relationship between whole blood and plasma glucose measurements will be reported.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Relationship between whole blood and plasma glucose in venous blood samples in pregnancy.
In venous blood samples, glucose will be measured in both whole blood and plasma on the YSI analyser. The relationship between whole blood and plasma glucose measurements will be reported.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Relationship between capillary whole blood and venous whole blood glucose in pregnancy.
Glucose will be measured on the YSI analyser in paired capillary whole blood and venous whole blood samples. The relationship between capillary and venous whole blood glucose will be reported.
Paired means samples taken at the same time.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Relationship between capillary plasma glucose and venous plasma glucose in pregnancy.
Glucose will be measured on the YSI analyser in paired capillary plasma and venous plasma samples. The relationship between capillary and venous plasma glucose will be reported.
Paired means samples taken at the same time.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Sensitivity of HbA1c for screening for GDM versus gold standard of 75g OGTT and VPG-YSI measurement (NICE 2015 criteria).
HbA1c (haemoglobin A1c, glycated haemoglobin) measured on venous whole blood in a hospital laboratory (IFCC standardised).
VPG-YSI is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements.
NICE (National Institute for Health and Care Excellence) 2015 diagnostic criteria for GDM are: fasting venous plasma glucose ≥ 5.6mmol/L, 2-hour post 75g oral glucose venous plasma glucose ≥ 7.8mmol/L.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Specificity of HbA1c for screening for GDM versus gold standard of 75g OGTT and VPG-YSI measurement (NICE 2015 criteria).
HbA1c (haemoglobin A1c, glycated haemoglobin) measured on venous whole blood in a hospital laboratory (IFCC standardised).
VPG-YSI is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements.
NICE (National Institute for Health and Care Excellence) 2015 diagnostic criteria for GDM are: fasting venous plasma glucose ≥ 5.6mmol/L, 2-hour post 75g oral glucose venous plasma glucose ≥ 7.8mmol/L.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Sensitivity of HbA1c for screening for GDM versus gold standard of 75g OGTT and VPG-YSI measurement (IADPSG 2010 criteria).
HbA1c (haemoglobin A1c, glycated haemoglobin) measured on venous whole blood in a hospital laboratory (IFCC standardised).
VPG-YSI is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements.
IADPSG (the International Association of Diabetes and Pregnancy Study Groups) 2010 diagnostic criteria for GDM are: 1 or more of fasting venous plasma glucose ≥ 5.1mmol/L, 1-hour post 75g oral glucose venous plasma glucose ≥ 10.0mmol/L or 2-hour post 75g oral glucose venous plasma glucose ≥ 8.5mmol/L.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Specificity of HbA1c for screening for GDM versus gold standard of 75g OGTT and VPG-YSI measurement (IADPSG 2010 criteria).
HbA1c (haemoglobin A1c, glycated haemoglobin) measured on venous whole blood in a hospital laboratory (IFCC standardised).
VPG-YSI is venous plasma glucose measured on YSI 2300 Stat Analyser (YSI Life Sciences), a recognised reference standard, average of 2 measurements.
IADPSG (the International Association of Diabetes and Pregnancy Study Groups) 2010 diagnostic criteria for GDM are: 1 or more of fasting venous plasma glucose ≥ 5.1mmol/L, 1-hour post 75g oral glucose venous plasma glucose ≥ 10.0mmol/L or 2-hour post 75g oral glucose venous plasma glucose ≥ 8.5mmol/L.
Measured: Each participant is studied on one occasion between 16-34 weeks gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startMar 2016
- Primary completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Collaboration for Leadership in Applied Health Research and Care, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Katharine F Hunt, MBBS MRCP, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117543
- Sponsor's protocol ID
- KCH16-035
- Other IDs
- 15/LO/1494, 180588
- Status last verified
- Oct 2018
- First submitted
- 11 Jul 2016
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Diagnostic Approaches in Gestational Diabetes (GDM) and the Impact of Ethnicity on Markers of Glycaemia in Pregnancy
- ClinicalTrials.gov ID
- NCT03117543
- Acronym / sponsor ID
- KCH16-035
- Conditions
- Diabetes, Gestational
- Keywords
- Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London, Collaboration for Leadership in Applied Health Research and Care, United Kingdom
- Study start
- Mar 2016
- Primary completion
- 30 Apr 2019 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (8 listed)
- Pregnant woman at least 18 years of age
- 16-34 weeks gestation.
- Booked for pregnancy care at a participating centre
- Able to give informed consent to participate
- Women who are of White European, Black African or Black Caribbean ethnicity.
Key exclusion criteria (7 listed)
- Main study
- Unable to give informed consent
- Known pre-pregnancy diabetes
- GDM diagnosed in the current pregnancy
- Substudy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
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.
14 secondary outcomes
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Specificity of the hOGTT system for diagnosis of GDM using IADPSG 2010 criteria (gold standard VPG-YSI).
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Relationship between whole blood and plasma glucose in capillary blood samples in pregnancy.
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Relationship between whole blood and plasma glucose in venous blood samples in pregnancy.
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Relationship between capillary whole blood and venous whole blood glucose in pregnancy.
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Relationship between capillary plasma glucose and venous plasma glucose in pregnancy.
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Sensitivity of HbA1c for screening for GDM versus gold standard of 75g OGTT and VPG-YSI measurement (NICE 2015 criteria).
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Specificity of HbA1c for screening for GDM versus gold standard of 75g OGTT and VPG-YSI measurement (NICE 2015 criteria).
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Sensitivity of HbA1c for screening for GDM versus gold standard of 75g OGTT and VPG-YSI measurement (IADPSG 2010 criteria).
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Specificity of HbA1c for screening for GDM versus gold standard of 75g OGTT and VPG-YSI measurement (IADPSG 2010 criteria).
Time frame: Each participant is studied on one occasion between 16-34 weeks gestation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine F Hunt, MBBS MRCP principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, Gestational, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katharine F Hunt, MBBS MRCP (00442078485663, katharine.f.hunt@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Each participant is studied on one occasion between 16-34 weeks gestation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.