Gestational Diabetes MellitusPhase 3NCT02478762
Glycemic Objectives of Women With Gestational Diabetes Mellitus
A Phase 3 study of Gestational Diabetes Mellitus, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Dec 2016
- Phase
- Phase 3
- 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
Who may be able to join
- gestational age between 15 and 32 weeks since last menstrual date,
- received education on gestational diabetes mellitus,
- able to read and understand French.
Who cannot join
- known type 1 or type 2 diabetes,
- treatment interfering woth glucose metabolism,
- deficit may hinder the understanding of the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5N4
About this study
Official title: Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus
In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with GDM had significantly higher FGH that newborn of women without GDM.
In this study, the investigators want to compare the FGH of newborn of GDM women randomized to a group reaching the Canadian Diabetes Association recommended blood glucose objectives treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Normal glycemic control, Low glycemic control
- Keywords
- Foetal glycated hemoglobin, Glycemic objectives treatment
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal glycemic controlProcedure or surgery
Use diet, physical exercise of insulins to reach normal glycemic control.
Low glycemic controlProcedure or surgery
Use diet, physical exercise of insulins to reach low glycemic control.
| Study group | Role | What they receive |
|---|---|---|
| Normal glycemic control | Active comparator | GDM women in this group will reach glycemic objectives recommended by the Canadian Diabetes Association: fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L. Receives: Procedure: Normal glycemic control |
| Low glycemic control | Experimental | GDM women in this group will reach lower glycemic objectives than those recommended by the Canadian Diabetes Association: fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L. Receives: Procedure: Low glycemic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foetal glycated hemoglobin
Measured: At delivery
Secondary outcomes (1)
Treatment satisfaction
Evaluated by questionnaire
Measured: End of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: very difficult recruitment
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT02478762
- Sponsor's protocol ID
- 14-160
- 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
- Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02478762
- Acronym / sponsor ID
- 14-160
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Foetal glycated hemoglobin, Glycemic objectives treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very difficult recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 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.
In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with GDM had significantly higher FGH that newborn of women without GDM.
In this study, the investigators want to compare the FGH of newborn of GDM women randomized to a group reaching the Canadian Diabetes Association recommended blood glucose objectives treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal glycemic control | Active comparator | Procedure: Normal glycemic controlGDM women in this group will reach glycemic objectives recommended by the Canadian Diabetes Association: fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L. |
| Low glycemic control | Experimental | Procedure: Low glycemic controlGDM women in this group will reach lower glycemic objectives than those recommended by the Canadian Diabetes Association: fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- gestational age between 15 and 32 weeks since last menstrual date,
- received education on gestational diabetes mellitus,
- able to read and understand French.
Key exclusion criteria (3 listed)
- known type 1 or type 2 diabetes,
- treatment interfering woth glucose metabolism,
- deficit 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 |
|---|---|---|
| Normal glycemic controlUse diet, physical exercise of insulins to reach normal glycemic control. | Procedure or surgery | Normal glycemic control |
| Low glycemic controlUse diet, physical exercise of insulins to reach low glycemic control. | Procedure or surgery | Low glycemic control |
Primary outcome
Foetal glycated hemoglobin
Time frame: At delivery
1 secondary outcome
Treatment satisfaction
Time frame: End of pregnancy
Results and safety
The study was stopped early (reason given: very difficult recruitment). Results are not available in the source record.
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?
A Phase 3 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 3 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: stopped early, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: very difficult recruitment). Results are not available in the source record.
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?
Foetal glycated hemoglobin (time frame: At delivery). 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.