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临床试验/NCT02313363
NCT02313363已完成1 期

Feasibility of a Patient-Centered Smartphone-Based Diabetes Care System: a Pilot Study

Seoul National University Hospital0 个研究点目标入组 30 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
30
主要终点
change of HbA1c

研究概览

简要总结

The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS). This study was aimed to test the feasibility of the PSDCS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •type 2 diabetes
  • •HbA1c levels ≥ 6.5%

排除标准

  • •severe diabetic complication including severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy, chronic kidney disease stage 4-5, severe diabetic neuropathy, history of diabetic foot, history of angina pectoris, myocardial infarction, and cerebrovascular disease, and peripheral arterial disease
  • •type 1 diabetes
  • •insulin therapy other than insulin glargine
  • •subjects with insulin pump
  • •history of drug addiction
  • •history of psychotic disorder
  • •pregnancy

研究组 & 干预措施

PSDCS

Experimental

using the patient-centered smartphone-based diabetes care system (PSDCS) for 12 weeks

干预措施: patient-centered smartphone-based diabetes care system (Device)

结局指标

主要结局

change of HbA1c

时间窗: baseline and the end of 12 week

次要结局

  • change of fasting plasma glucose(baseline and after 12 weeks (within 3 days))
  • change of lipid profile(baseline and after 12 weeks (within 3 days))
  • change of body weight(baseline and after 12 weeks (within 3 days))
  • change of the scores of Summary of Diabetes Self-Care Activities (SDSCA)(baseline and after 12 weeks (within 3 days))

研究者

申办方类型
Other
责任方
Sponsor

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