Diagnosis Test for Gestational Diabetes Mellitus

Assessment of the Diagnosis Test for Gestational Diabetes Mellitus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02482662

Enrollment

104

Registered

2015-06-26

Start date

2014-11-30

Completion date

2017-10-31

Last updated

2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Keywords

Diagnosis

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.

Interventions

PROCEDUREDiagnosis

Oral glucose tolerance test and self-monitoring blood glucose

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026