NCT02313363已完成早期 1 期
Feasibility of a Patient-Centered Smartphone-Based Diabetes Care System: a Pilot Study
适应症
试验速览
- 阶段
- 早期 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
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
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