Peripartum Management of Gestational Diabetes Using a Digital Healthcare Service: a Pilot, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- hemoglobin A1c levels
研究概览
简要总结
The prevalence of gestational diabetes mellitus (GDM) has been progressively increasing. It is important to recognize and treat GDM to minimize the risk of maternal and neonatal complications. Multifaceted professional interventions are effective in the management of GDM and mobile healthcare can be an effective approach. The purpose of the current study was to develop and evaluate a model for prevention and management of GDM using mobile healthcare. Subjects with no previous history of diabetes, who were diagnosed with GDM during 24-28 weeks of gestation, were randomly divided into a conventional management group and a mobile management group. The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application. The mobile management group received mobile healthcare services including tailored mobile coaching. The effectiveness of the management using the application were evaluated through the result values of the laboratory tests, anthropometric measurement performed during the study period and perinatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnant women diagnosed as GDM at 24 to 28 weeks of gestation were included.
排除标准
- •Patients after 30th week of gestation and patients with pregestational diabetes were excluded from participating in the study. Patients who were unable to understand Korean, were unfamiliar with mobile phones, who did not have access to a mobile phone, or who were already receiving services from another mobile healthcare agency were also excluded.
研究组 & 干预措施
conventional management group
The conventional management group received standard GDM management and could freely use the smartphone healthcare application.
mobile management group
The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching.
干预措施: Smartphone application (Other)
结局指标
主要结局
hemoglobin A1c levels
时间窗: up to 4 to 12weeks after delivery
serum glycated hemoglobin levels
次要结局
- body weight(up to 4 to 12weeks after delivery)
- percent body fat(up to 4 to 12weeks after delivery)
- HOMA IR(homeostatic model assessment insulin resistance)(up to 4 to 12weeks after delivery)
- body mass index(up to 4 to 12weeks after delivery)
- HOMA-ß (homeostatic model assessment ß-cell dysfunction )(up to 4 to 12weeks after delivery)
- Neonate large for gestational age(at the day of delivery)
- Mode of delivery(at the day of delivery)
研究者
Cheol-Young Park
Professor, Division of Endocrionology and metabolism, Department of Internal medicine
Kangbuk Samsung Hospital