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临床试验/NCT07173959
NCT07173959尚未招募不适用

Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus

Peking Union Medical College Hospital0 个研究点目标入组 160 人开始时间: 2025年10月8日最近更新:

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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