Assessment of the Diagnosis Test for Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- proportion of OGTTs falsely negative
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •known type 1 or type 2 diabetes,
- •disease or treatment interfering with the metabolism of glucose,
- •deficiency may hinder the understanding of the study.
结局指标
主要结局
proportion of OGTTs falsely negative
时间窗: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT
次要结局
- preference of participants regarding the two tests (OGTT vs. SMBG)(Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT)
研究者
Jean-Luc Ardilouze
Endocinologist
Université de Sherbrooke