A Randomized Controlled Trial Evaluating the Effect of Virtual Patient-centered Education on Infant Birthweight in Women With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 621
- 试验地点
- 1
- 主要终点
- Birthweight standard deviation score
研究概览
简要总结
A randomized controlled trial evaluating whether a patient-centered virtual educational tool based on small videos focusing on optimization of mental health, diet, physical activity, self-adjustment of insulin dose and use of diabetes technology in addition to usual individual face-to-face education, will improve glycemic control and pregnancy outcome in women with pre-existing diabetes mellitus compared to women receiving usual individual face-to-face education alone.
详细描述
ETOS-DM is a national RCT evaluating the effect of combined virtual patient-centered education based on a tool of small videos accessible via smartphones in addition to usual individual face-to-face education during pregnancy or to routine individual face-to-face education only.
The small educational videos covering topics as food choices, physical activity, self-adjustment of insulin dose insulin pump settings during pregnancy, use of CGM during pregnancy, mental health among others,each of 1-4 minutes duration, will be developed in collaboration with user representatives (women with pre-existing diabetes who are or have recently been pregnant) and relevant health care professionals.
The inclusion period of the ETOS-DM study starts on September 1st 2023 and ends on August 31st 2025.
Pregnant women with pre-existing diabetes will be randomized before 14 gestational weeks. The women in the intervention group will have free, unlimited access to approximately 10 educational videos. The use of these virtual educational videos will be monitored and the women's own experience with the videos will be explored. The women will be followed during pregnancy, delivery until one month after delivery. Both groups of women follow usual local care and local face-to-face education which is allowed to change during the study period.
Stratification will be performed for diabetes center, for diabetes type and, in women with type 1 diabetes, use of MDI or insulin pump.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, age ≥ 18 years
- •Type 1 diabetes, type 2 diabetes or other types of pre-existing diabetes (e.g., maturity onset diabetes of the young (MODY))
- •Pregnant with one or more intrauterine living foetus(es) (5 to 13 completed gestational weeks) at inclusion confirmed by an ultrasound scan)
排除标准
- •A diagnosis with severe mental or psychiatric barriers or a concurrent disease based on the decision of the investigator
- •No proficiency in Danish to understand oral and written information
- •To secure independent observations, women can be randomized in the ETOS-DM study only once.
研究组 & 干预措施
Control
Randomized to usual care without acces to video-based education
Intervention
Randomization to video-based education in addition to ussual care
干预措施: Video-based education (Other)
结局指标
主要结局
Birthweight standard deviation score
时间窗: At delivery
Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score)
次要结局
- HbA1c during pregnancy(At inclusion, at 21 weeks, at 33 weeks and at 35 weeks)
- Severe hypoglycemia(2 years)
- Prevalence of birth complications(At birth and one month post delivery)
- Continuous glucose monitoring data(Throughout pregnancy and 1 month post delivery)
- Fetal overgrowth(At birth)
- Major congenital malformations(9 months)
- Maternal weight gain(At inclusion, at 21 weeks, at 33 weeks, 35 weeks and one month after delivery)
- Individuel insulin pump settings in women using insulin pump(At inclusion, at 21 weeks, at 33 weeks, 35 weeks, at delivery and one month after delivery)
- Prevalence of neonatal morbidity(1 month)
- Maternal reported outcomes during pregnancy and one month postpartum(In early pregnancy, in late pregnancy and one month post-partum.)
- Pregnancy complications(9 months)
- Partner reported outcomes during pregnancy and one month postpartum(In early pregnancy, in late pregnancy and one month post-partum.)
- Continuous glucose monitoring metrics 1 months post delivery(1 months)
- Infant growth at one month of age(1 month)