Gestational Diabetes MellitusNCT02482662
Diagnosis Test for Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Diagnosis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Oct 2017
- 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: Women with abnormal GDM screening test.
Who may be able to join
- positive GDM screening test (glycemia post-50g of glucose ≥ 7.2 mmol/L),
- between 24 and 28 weeks of gestation from the last menstruation,
- single pregnancy,
- able to read and understand French.
Who cannot join
- known type 1 or type 2 diabetes,
- disease or treatment interfering with the metabolism of glucose,
- deficiency may hinder the understanding of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Diagnosis Test for Gestational Diabetes Mellitus
Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by pregnant women. As many OGTT are false positive according to self-monitoring blood glucose (SMBG), the investigators need now to determine the percentage of OGTT results that are false negative.
The comparison of the two tests (OGTT and SMBG) in the same patient with normal results of OGTT will determine the exact percentage of false negative OGTT results.
The opinion of women will also be taken into account. In the everyday clinic, many report that they prefer SMBG to OGTT because they do not have to be fasting, to drink non palatable drink and to attend a 2-hour visit in their schedule. However, no opinion study has yet been performed, the investigators will investigate formally what women think using a questionnaire.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Diagnosis
- Keywords
- Diagnosis
- Medical subject headings
- Diabetes, Gestational, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosisProcedure or surgery
Oral glucose tolerance test and self-monitoring blood glucose
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of OGTTs falsely negative
Measured: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT
Secondary outcomes (1)
preference of participants regarding the two tests (OGTT vs. SMBG)
Evaluated by questionnaire
Measured: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Luc Ardilouze, Université de Sherbrooke
- Investigators
- Jean-Luc Ardilouze, MD, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482662
- Sponsor's protocol ID
- 14-159
- Status last verified
- May 2018
- First submitted
- 16 Jun 2015
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Diagnosis Test for Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02482662
- Acronym / sponsor ID
- 14-159
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Jun 2015 (estimated)
- 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 mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by pregnant women. As many OGTT are false positive according to self-monitoring blood glucose (SMBG), the investigators need now to determine the percentage of OGTT results that are false negative.
The comparison of the two tests (OGTT and SMBG) in the same patient with normal results of OGTT will determine the exact percentage of false negative OGTT results.
The opinion of women will also be taken into account. In the everyday clinic, many report that they prefer SMBG to OGTT because they do not have to be fasting, to drink non palatable drink and to attend a 2-hour visit in their schedule. However, no opinion study has yet been performed, the investigators will investigate formally what women think using a questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with abnormal GDM screening test.
Key inclusion criteria (4 listed)
- positive GDM screening test (glycemia post-50g of glucose ≥ 7.2 mmol/L),
- between 24 and 28 weeks of gestation from the last menstruation,
- single pregnancy,
- able to read and understand French.
Key exclusion criteria (3 listed)
- known type 1 or type 2 diabetes,
- disease or treatment interfering with the metabolism of glucose,
- deficiency may hinder the understanding of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiagnosisOral glucose tolerance test and self-monitoring blood glucose | Procedure or surgery | – |
Primary outcome
proportion of OGTTs falsely negative
Time frame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT
1 secondary outcome
preference of participants regarding the two tests (OGTT vs. SMBG)
Time frame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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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.
Jean-Luc Ardilouze, MD, PhD principal investigator
Université de Sherbrooke
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 Gestational Diabetes Mellitus, run by Université de Sherbrooke at 1 site in Canada.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 3 May 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of OGTTs falsely negative (time frame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT). 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 3 May 2018.