NCT02451631Unknown不适用
A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service in Patients With Type 2 Diabetes Mellitus
Healthconnect3 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 184
- 试验地点
- 3
- 主要终点
- Change in HbA1c (%)
研究概览
简要总结
A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus
详细描述
The Mobile Diabetes Intervention Study is evaluating a diabetes mgmt. algorithm system by using patient mobile application and physician web-based portal. The investigators hypothesize that patient self-monitoring of blood glucose, dietary and exercise by using application and physician's remote monitoring can additional decrease of HbA1c over 6 month.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-80 years of age
- •Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months)
- •in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day
- •HbA1c between 7.0% and 10.0%
- •ability to understand and use smartphone application
排除标准
- •type 1 diabetes or patients using insulin pump
- •severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary & peripheral artery within recent 6 months)
- •uncontrolled hypertension
- •pregnant woman, fertile woman who will not use contraception
- •unable to use application during treatment
- •taking medication which can affect on glucose level
- •alcohol abuse or dependency
- •over 2.5 times from the upper limit of liver enzyme level
- •DKA(diabetic ketoacidosis) or HHS(Hyperglycemic hyperosmolar syndrome) history during recent 6 months
结局指标
主要结局
Change in HbA1c (%)
时间窗: Change from baseline to 24 weeks
次要结局
- Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)(from baseline to 24weeks)
- Change in FBG(Fasting Blood Glucose)(from baseline to 12weeks and 24weeks)
- Change in HbA1c (%)(Change from baseline to 12 weeks)
- Change in SDSCA(Summary of Diabetes Self-Care Activities)(from baseline to 24 weeks)
研究者
研究点 (3)
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