Diagnosis Test for Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

Official title:

Assessment of the Diagnosis Test for Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482662
• Other study ID #: 14-159
• Status: Completed
• Start date: November 2014
• Est. completion date: October 2017

Study information

• Verified date: May 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Canada	Centre de recherche clinique du CHUS	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of OGTTs falsely negative		Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT
Secondary	preference of participants regarding the two tests (OGTT vs. SMBG)	Evaluated by questionnaire	Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT