Randomized Controlled Clinical Trial of Telemedicine-guided Lifestyle Intervention in Diabetic Patients During Intensive Insulin Therapy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change of HbA1c level
研究概览
简要总结
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy.
详细描述
The primary objective of this study was to evaluate the development of HbA1c levels in patients requiring 3 months of intensified insulin therapy using standard therapy and telemedicine devices currently in use.
The telemedicine system contains a mobile phone-based nutrition diary, bluetooth-related wrist activity meter, weight scale, blood pressure monitor, blood glucose meter, and IT system for transmitting and displaying data from these devices.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men between the ages of 18 and 75
- •Patient with Diabetes who needs intensified insulin therapy HbA1c> = 8%
- •IT proficiency is at least basic for cell phones (answering / making a voice call).
- •Signing a informed consent
- •For women with childbearing potential, by definition, all women who who are physiologically able to conceive are twofold use of contraception
- •The subject communicates well with the investigator and is able to perform the test to understand and help comply with the requirements of the protocol
排除标准
- •informed refusal any time after the sign of the informed consent
- •Planned invasive cardiac intervention (catheter vasodilation or surgical coronary artery bypass grafting, keyboard surgery or replacement)
- •Tumor disease
- •Pregnant or lactating women
- •Any medical condition that does not allow participation
结局指标
主要结局
Change of HbA1c level
时间窗: 3 months
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on HbA1c levels in individuals requiring insulin therapy
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(3 months)
- change of hypoglycemic episodes(3 months)
- Difference in the decisions between the two type of visits(3 months)