Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- The rate of achieving blood glucose targets
研究概览
简要总结
Existing studies have shown that the management combined with digital health technology can increase the qualified rate of blood glucose in pregnant women with gestational diabetes mellitus (GDM), and the earlier the intervention, the better the effect of blood glucose control. Previously, there was a lack of relevant research on digital therapeutics for the systematic management of gestational diabetes in China. A data-driven digital therapy product for gestational diabetes (doctor's end + patient's end) was established. This product integrates functions such as information recording, risk assessment, evaluation and suggestion, prescription issuance, and knowledge popularization. It aims to provide personalized blood glucose regulation plans for pregnant women with gestational diabetes and enhance the health awareness and self-management ability of families with gestational diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •24 to 28 weeks of pregnancy GDM was diagnosed by OGTT test single pregnancy Be able to use smart phone APP to conduct intervention management based on digital therapy software program
排除标准
- •Suffering from type 1 or type 2 diabetes Other serious organic diseases With severe mental disorders Intervention management cannot be carried out as planned using digital therapeutics
结局指标
主要结局
The rate of achieving blood glucose targets
时间窗: From enrollment to the end of treatment at 16 weeks
次要结局
- Weight gain during pregnancy(From enrollment to the end of treatment at 16 weeks)
- The incidence of adverse pregnancy outcomes(During childbirth)
