eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study (Phase 2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in fasting glucose
研究概览
简要总结
The overall aim of the eMOM GDM-project is to develop and evaluate a novel system to clinical decision making and patient behavior change in treatment of GDM, combining diet, physical activity, sleep, heart rate (e.g. stress), and glucose monitoring within a single system (the eMOM GDM application), and linking the developed application tool for the normal health care system in a new way.
In this second phase of the project, the effect of eMOM GDM application on maternal and neonatal outcomes will be evaluated in a randomized controlled study design. The follow-up study continues until 3 months postpartum.
详细描述
200 women with gestational diabetes will be randomized into the intervention and the control group at gestational week (GW) 24-28.
Participants in the intervention group will use the eMOM GDM -application one week/month until delivery.
The participants in the intervention and the control group visit study nurse 3 times in study period (at GW 24-28 and GW 35-37 and 3 months postpartum).
Both groups also receive regular antenatal care in maternity clinics and hospitals.
Maternal measurements at enrollment, and at 35-37 GW (both groups):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Data will be anonomized (ID coded)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •GDM diagnoses at 24-28 gestational weeks
排除标准
- •type 1 or type 2 diabetes
- •use of medication that influences glucose metabolism (such as continuous therapy with oral corticosteroids or metformin)
- •multiple pregnancy
- •physical disability
- •current substance abuse
- •severe psychiatric disorder (that complicates participation to the study)
- •significant difficulty in cooperating (e.g. inadequate Finnish language skills)
结局指标
主要结局
Change in fasting glucose
时间窗: from gestational weeks 24-28 to gestational weeks 35-37
change in fasting glucose measured by Huslab (laboratory measurement)
次要结局
- Gestational weight(weight measured at gestational weeks 24-28 and at 35-37 and collected from antenatal card during whole pregnancy and up to delivery)
- Fingertips fasting glucose values(from gestational weeks 24-28 up to delivery)
- Fingertips area under the glucose curve(from gestational weeks 24-28 up to delivery)
- Neonatal body fat%(one measure within 0-3 days after birth of the child)
- Fingertips postbrandial glucose values(from gestational weeks 24-28 up to delivery)
- Total diet(at gestational weeks 24-28), 35-37 and at 3 months postpartum)
- Postpartum weight(weight measured at 3 months postpartum)
- Physical activity level(at gestational weeks 24-28, 35-37 and at 3 months postpartum)
- Costs(gestational weeks 24-28, 3 months postpartum)
- Motivation to manage GDM(at gestational weeks 24-28 and 35-37)
- Percentage of participants on metformin treatment(up to 42 gestational weeks)
- Percentage of participants on insulin treatment(up to 42 gestational weeks)
- Newborn birthweight and macrosomia(one measure at birth)
- Incidence of neonatal hypoglycemia(within a week from birth)
- 2-h OGTT(3 months postpartum)
- Incidence of newborn large for gestational age(one measure at birth)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum)
- Stress levels(gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum)
研究者
Saila Koivusalo
MD Adjunct prof
Helsinki University Central Hospital