A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of Smartphone Application in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- hemoglobin A1c levels
研究概览
简要总结
Since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement and management of living habits are as significant as medical care with regard to the disease. In addition, this is regarded as the most effective method for prevention and treatment of diabetes. However, many diabetic patients are now reported to lack proper management in Korea with a low level of compliance with treatment instruction. In that sense, it is urgently necessary to develop a program in which diabetic patients are able to effectively manage their own blood glucose at home, and to grasp the real state of self-blood glucose measurement. Accordingly, a system to manage diabetes using electronic equipment such as mobile phone or the Internet is currently being developed and studied, for the effective management of diabetes with the help of highly evolving information technology. These investigators have developed a diabetes management program that provides an optimal solution based on a mobile device and software, so that individual patients can undergo a regular blood glucose test and achieve improvement and constant management of living habits by being properly informed of how to manage diabetes. This clinical study was designed to evaluate the effectiveness and efficacy of the application through the comparison between usual medical care and additional care using the smartphone application, targeting patients with type 2 diabetes who lack blood glucose control. This study is targeted at the subjects who are being treated at this hospital's endocrinology, are using a smartphone, and voluntarily signed the informed consent form (ICF). The subjects who pass the subject eligibility evaluation provide information regarding assessment items and demographic information using the smartphone application and questionnaire. Based on the information given by subjects, the medical team offers a management system that supports and improves the existing treatment process of diabetes using the application developed on its own. The feasibility and effectiveness of the management using the application are evaluated through the result values of the laboratory tests performed during the subject's usual medical care.
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
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged ≥ 19 years;
- •android smartphone users;
- •no changes in medication for diabetes for at least 6 months;
- •HbA1c levels ≥6.5% within the last 3 months.
排除标准
- •currently had serious concomitant disease other than diabetes (n=1); malignancy-related histories on admission, myocardial infarction, cerebral infarction or organ transplantation;
- •pregnant or had plans for pregnancy within 6 months;
- •plans to participate in other clinical studies or illiteracy.
结局指标
主要结局
hemoglobin A1c levels
时间窗: at six months
serum glycated hemoglobin levels
次要结局
- Audit of Diabetes Dependent Quality of Life(at six months)
- serum triglyceride(at six months)
- serum high-density lipoprotein cholesterol(at six months)
- the Korean version of the Appraisal of Diabetes Scale(at six months)
- the Problem Areas in Diabetes(at six months)
- serum low-density lipoprotein cholesterol(at six months)
- blood pressure(at six months)
- body mass index(at six months)
- Summary of Diabetes Self-Care Activities Questionnaire(at six months)
研究者
Cheol-Young Park
Professor
Kangbuk Samsung Hospital
