Glycemic Objectives of Women With Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus
Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Normal glycemic control
Low glycemic control
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring Foetal glycated hemoglobin, Glycemic objectives treatment
Eligibility Criteria
Inclusion Criteria:
- gestational age between 15 and 32 weeks since last menstrual date,
- received education on gestational diabetes mellitus,
- able to read and understand French.
Exclusion Criteria:
- known type 1 or type 2 diabetes,
- treatment interfering woth glucose metabolism,
- deficit may hinder the understanding of the study.
Sites / Locations
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal glycemic control
Low glycemic control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Foetal glycated hemoglobin
Secondary Outcome Measures
Treatment satisfaction
Evaluated by questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02478762
Brief Title
Glycemic Objectives of Women With Gestational Diabetes Mellitus
Official Title
Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
very difficult recruitment
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Foetal glycated hemoglobin, Glycemic objectives treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal glycemic control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low glycemic control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Normal glycemic control
Intervention Description
Use diet, physical exercise of insulins to reach normal glycemic control.
Intervention Type
Procedure
Intervention Name(s)
Low glycemic control
Intervention Description
Use diet, physical exercise of insulins to reach low glycemic control.
Primary Outcome Measure Information:
Title
Foetal glycated hemoglobin
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Treatment satisfaction
Description
Evaluated by questionnaire
Time Frame
End of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gestational age between 15 and 32 weeks since last menstrual date,
received education on gestational diabetes mellitus,
able to read and understand French.
Exclusion Criteria:
known type 1 or type 2 diabetes,
treatment interfering woth glucose metabolism,
deficit may hinder the understanding of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Ardilouze, MD, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
12. IPD Sharing Statement
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Glycemic Objectives of Women With Gestational Diabetes Mellitus
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