Diagnosis Test for Gestational Diabetes Mellitus

NCT02482662 | Completed

• 1 other identifier: 14-159
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (1)

• proportion of OGTTs falsely negative

  Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT

Secondary Outcomes (1)

• preference of participants regarding the two tests (OGTT vs. SMBG)

  Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT

Interventions

Diagnosis PROCEDURE

Oral glucose tolerance test and self-monitoring blood glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with abnormal GDM screening test.

You may qualify if:

• 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.

You may not qualify if:

• known type 1 or type 2 diabetes,
• disease or treatment interfering with the metabolism of glucose,
• deficiency may hinder the understanding of the study.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche clinique du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational; Disease

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Luc Ardilouze, MD, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocinologist

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 26, 2015
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

CA (1)