Diagnosis Test for Gestational Diabetes Mellitus

May 2, 2018 updated by: Jean-Luc Ardilouze, Université de Sherbrooke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de recherche clinique du CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with abnormal GDM screening test.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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