A Pilot Study of Self Management Using Application for Chronic Disease Care in Real siTuation (SMART) - DM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- fasting serum glucose and HbA1c
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (DM).
Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. However, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 DM.
Thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.
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
- 21 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 DM using oral hypoglycemic agent
- •6.5% < HbA1c < 10%
- •systolic blood pressure > 130 mmHg or diastolic blood pressure > 80 mmHg
- •BMI over 23.0
- •20 < age < 70
- •smartphone user (android OS based)
排除标准
- •Serum fasting glucose > 250 mg/L or post prandial 2 hour serum glucose > 350 mg/L
- •systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
- •Diabetes mellitus patient using insulin
- •severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria)
- •congestive heart failure (NYHA III-IV or left ventricular ejection fraction < 30%)
- •Aspartate aminotransferase (AST) or alanine transaminase (ALT) over 3 times of upper normal limit
- •Serum creatinine > 1.5 mg/dL
- •refusal to participate in the study
- •drug addiction or alcohol addiction
- •major psychiatric illness
- •steroid treatment or hormonal treatment with changing the drug or drug dosage in 1 month
- •changing dosage of antihypertensive agent, oral hypoglycemic agent or lipid lowering agent in 1 month
- •malignant cancer
- •pregnancy
结局指标
主要结局
fasting serum glucose and HbA1c
时间窗: 3months after enrollemnt (day 0-day 90)
we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90)
次要结局
- Lipid profile(3months after enrollment (day 0-90))
- body weight and BMI(3months after enrollemnt (day 0-day 90))
研究者
Jongha Park
Study principal investigator
Inje University