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临床试验/NCT04424238
NCT04424238Unknown不适用

Clinical Research on Mobile Medical Used for the Standardized Management of Gestational Diabetes: a Randomized Control Trail

Peking Union Medical College Hospital0 个研究点目标入组 400 人开始时间: 2016年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
主要终点
glycemic qualification rate

研究概览

简要总结

A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.

详细描述

Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged between 18 and 45 years.
  • With singleton pregnancy
  • Diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
  • Be able to use smart phone for chatting, read and write basic Chinese.
  • Volunteer for research.

排除标准

  • Pregnancies with diagnosed chronic disease
  • Pregnancies with other pregnancy complications except GDM
  • Pregnancies had recent trauma and treatment of glucocorticoids

结局指标

主要结局

glycemic qualification rate

时间窗: From enrollment to 42 days postpartum

Glycemic qualification rate was calculated by the number of BG within the control range /30\*100%. BG control range were fasting BG (fasting and before-sleep BG)\<95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)\<120 mg/dL (6.7 mmol/L)

次要结局

  • pregnancy outcome(delivery)

研究者

申办方类型
Other
责任方
Sponsor

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