A Telemedicine Platform for Patients With Type 1 Diabetes Mellitus Treated With an Hybrid Closed Loop System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Impact on quality of life
研究概览
简要总结
The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria for DM1 according to ADA
- •They must have access to the technology that allows monitoring (mobile phone and / or computer as well as having an internet connection)
- •Acceptance of participation in the study and signing of the informed consent
排除标准
- •Gestation
- •Institutionalization, serious or terminal illness or renal replacement therapy.
- •Inability to undertake the training and / or acquire the degree of knowledge to use the telemedicine platform.
- •Refusal to participate in the study or to sign the informed consent
结局指标
主要结局
Impact on quality of life
时间窗: 12 months
Health-related quality of life in patients with type 1 diabetes (the ViDa1 questionnaire). The four-dimensional structure for ViDa1 are: * Interference of diabetes in everyday life (the minimum value: 12 and maximum value: 60) higher scores mean a worse outcome * Self-care (the minimum value: 11 and maximum value: 55) higher scores mean a better outcome * Well-being (the minimum value: 6 and maximum value: 30) higher scores mean a better outcome, and * Worry about the disease (the minimum value: 5 and maximum value: 25) higher scores mean a worse outcome.
次要结局
- Metabolic control(12 months)