Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in HbA1c of experimental group
研究概览
简要总结
Objective: evaluation of effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus Outline: Among the patients with type 1 diabetes, the group with telemedicine and education using smartphone set as a experimental group and the group without those set as a control group, respectively.
Sample size: experimental group (n=50), control group (n=50) Inclusion criteria: patients with type 1 diabetes with A1c>8.0% Exclusion criteria: chronic disease, psychological disease, children aged under 12 with parents with psychological disease, athletics Method: We divide subjects as an experimental group and a control group by randomization, and they visit outpatient clinic every 12 weeks. We perform telemedicine and education with smartphone application to the experimental group every 2 weeks. We evaluate the effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus with checking A1c and checklist at baseline, 12 weeks and 24 weeks after starting of the research.
Variables: A1c, satisfaction, knowledge, self-confidence, willing to continuing, quality of life, physical activity, drinking, smoking Primary endpoint: Improvement in HbA1c of experimental group Secondary endpoint: No improvement in HbA1c of control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 0 Months 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. patients aged under 30 with type 1 diabetes b. patients who control glucose level with multiple daily injection of insulin pump c. Patients who agree the task to check glucose level during the experiment d. patients who has been diagnosed as type 1 diabetes more than 3 months e. patients whose A1c more than 8.0% within 6 months f. Patients who can use smartphone all day 2) exclusion criteria
- •chronic disease (except thyroid disorders with euthyroidism), psychological disease
- •Patients aged under 12 whose parents have psychological disease
- •Patients who cannot use smartphone app properly
- •Patients who use continuous glucose monitoring
排除标准
- 未提供
结局指标
主要结局
change in HbA1c of experimental group
时间窗: 6 months
次要结局
- No change in HbA1c of control group(6 months later)