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
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|
|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|
- Procedure: Diagnosis
Oral glucose tolerance test and self-monitoring blood glucose
- proportion of OGTTs falsely negative [ Time Frame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT ]
- 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
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
|Centre de recherche clinique du CHUS|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Jean-Luc Ardilouze, MD, PhD||Université de Sherbrooke|