Diagnosis Test for Gestational Diabetes Mellitus

Completed

• Conditions: Gestational Diabetes Mellitus

• Registration Number: NCT02482662
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-26
• Primary Completion: 2015-12
• Study Completion: 2017-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of OGTTs falsely negative	Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT

Secondary Outcome Measures

Name	Time	Method
preference of participants regarding the two tests (OGTT vs. SMBG)	Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT	Evaluated by questionnaire

Trial Locations

Locations (1)

Centre de recherche clinique du CHUS; 🇨🇦 Sherbrooke, Quebec, Canada