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Diagnosis Test for Gestational Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02482662
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke

Brief 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. 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.


Condition or disease Intervention/treatment
Gestational Diabetes Mellitus Procedure: Diagnosis

Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Diagnosis Test for Gestational Diabetes Mellitus
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Diagnosis
    Oral glucose tolerance test and self-monitoring blood glucose


Primary Outcome Measures :
  1. proportion of OGTTs falsely negative [ Time Frame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT ]

Secondary Outcome Measures :
  1. 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 ]
    Evaluated by questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with abnormal GDM screening test.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • known type 1 or type 2 diabetes,
  • disease or treatment interfering with the metabolism of glucose,
  • deficiency may hinder the understanding of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482662


Locations
Canada, Quebec
Centre de recherche clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke

Responsible Party: Jean-Luc Ardilouze, Endocinologist, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02482662     History of Changes
Other Study ID Numbers: 14-159
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by Jean-Luc Ardilouze, Université de Sherbrooke:
Diagnosis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications