Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- System availability, acceptance, transmission rate
研究概览
简要总结
The purpose of the study is to show if telemonitoring and automated feedback regarding glucose management, physical activity, blood pressure, and body weight improves treatment of patients with insulin dependent Type 2 Diabetes mellitus.
详细描述
In this clinical trial 50 patients with insulin dependent type 2 diabetes will be randomised in two study arms: monitoring of blood glucose and blood pressure using a telemedical device or in an arm with treatment as usual. Patients will the following measurement devices: blood glucose, blood pressure. Both devices can communicate with a mobile phone, which will also be provided to the patients. The mobile phone will transfer the data to a central, safe server. Patients will receive automated reminder/feedback. Caregivers can evaluate the transferred data whenever necessary via a web-based access. Data will be presented in tables as well as trend figures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus Type 2, age 18-70 years, able to use a mobile phone
排除标准
- •Pacemaker, intracardial defibrillator, no cure planned within the active study period.
结局指标
主要结局
System availability, acceptance, transmission rate
时间窗: 3 months
次要结局
- HbA1c(3 months)