Overview

This trial is active, not recruiting.

Condition gestational diabetes mellitus
Treatment diagnosis
Sponsor Université de Sherbrooke
Start date November 2014
End date December 2015
Trial size 104 participants
Trial identifier NCT02482662, 14-159

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Assessment of the Diagnosis Test for Gestational Diabetes Mellitus
Principal investigator Jean-Luc Ardilouze, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Université de Sherbrooke.