Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 主要终点
- Change from HbA1c level at 3 months
研究概览
简要总结
The purpose of this study is to assess the efficacy of an electronic platform for doctor-patient communication in order to reduce severe and non-severe hypoglycemia events as well as inadvertent hypoglycemia events.
详细描述
This is an open randomized clinical trial without drugs. Patients with type 2 diabetes and treated with insulin will be included. Patients allocated in the intervention group will use the electronic platform as a communication channel with their health provider during the time between visits.
The name of the platform is ti.care (https://ti.care/es) and it will be a complement of the control visits to resolve doubts through chats, email or video call. Health providers will answer the patient requests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Aged over 17 years
- •Patients with type 2 diabetes diagnosis
- •Patients who start insulin treatment or with intensification of treatment
- •Patients who sign informed consent
排除标准
- •Patients with type 1 diabetes diagnosis
- •Life expectancy less than one year
- •Pregnancy
- •Patients with dementia
- •Patients with treatment different to insulin
- •Patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.
结局指标
主要结局
Change from HbA1c level at 3 months
时间窗: Baseline and at 3 months
Change from HbA1c level at 3 months
Change from postprandial blood glucose at 3 months
时间窗: Baseline and at 3 months
Change from postprandial blood glucose at 3 months
Number of inadvertent hypoglycemia events
时间窗: At 3 months
Number of inadvertent hypoglycemia events
Change from basal capillary blood glucose at 3 months
时间窗: Baseline and at 3 months
Change from basal capillary blood glucose at 3 months
Change from nocturnal blood glucose at 3 months
时间窗: Baseline and at 3 months
Change from nocturnal blood glucose at 3 months
Number of nocturnal hypoglycemia events
时间窗: At 3 months
Number of nocturnal hypoglycemia events
Total hypoglycemia
时间窗: At 3 months
Number of total hypoglycemia events
次要结局
未报告次要终点
研究者
Domingo Orozco
Principal investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana