Effect of Monitoring and Education of Step Number Assessed by Smartphone Application on Blood Glucose, Weight and Blood Pressure in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- change in daily step count after 12 weeks of intervention
研究概览
简要总结
In this study, investigators measured the number of steps, blood pressure, blood glucose, and weight in daily life through the smartphone personal health record application for patients with type 2 diabetes. The efficacy of text message intervention, which encourages an increase in the number of steps per week for 12 weeks, on an increase in the number of daily steps and changes in glucose levels, weight, and blood pressure will be investigated. Also, the durability of intervention will be checked after 12 weeks of intervention ending.
详细描述
This clinical study is a single institution, randomized, prospective study and monitors the average daily number of steps per week using a smartphone personal health record application developed by Samsung Medical Center for patients with type 2 diabetes. The study subjects were divided into five groups such as 1) basal activity (<2500 steps/day), 2) limited activity (2500-4999 steps/day), 3) low activity (5000-7499 steps/day), 4) somewhat active (7500-9999 steps/day), 5) active (10000-12499 steps/day), 6) highly active (≥12500 steps/day)according to the average number of steps per day. During the 12-week period, the intervention group receives the text messages that encourage step-by-step increments every week, and the control group does not receive text messages. The effect of 12-week step monitoring and education on the change in daily step count will be analyzed. Also, the effect of change in daily step count on glucose level, body weight, and blood pressure will be studied.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 diabetes aged 20-69 years
- •Patients with a HbA1c of less than 8.5% measured during screening (may be replaced by a test value within 3 months of screening visit )
- •Patients who have not been prescribed diabetic medication for the past 4 weeks or who have taken more than one oral hypoglycemic agent for more than 12 weeks at a certain dose
- •BMI ≥ 23 kg/m2
- •Available for use Samsung Galaxy S4 or later Android smartphone and wireless internet
- •Patients who voluntarily agreed to participate in this clinical study
排除标准
- •Diabetes other than type 2 diabetes, including type 1 diabetes, gestational diabetes
- •Patients who are taking insulin or GLP-1 agonist other than oral hypoglycemic agent
- •Patients with uncontrolled chronic liver disease
- •Patients with acute kidney injury
- •Patients with psychological disorder
- •Patients who are taking weight lowering agent
- •Patients with alcohol or drug addiction within the last 3
- •Patients who are taking systemic steroid
- •Patients who are breastfeeding or pregnant
- •Patients who did not voluntarily agree to the study
- •Patients who are unsuitable for participation in clinical research
研究组 & 干预措施
Intervention group
Intervention group receives weekly text messages which encourage the increment of daily step count
干预措施: Text messages (Other)
Control group
Control group does not receive text message
结局指标
主要结局
change in daily step count after 12 weeks of intervention
时间窗: Week 12
change in daily step count after 12 weeks of intervention
次要结局
- the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia(Week 24)
- High-density lipoprotein cholesterol(Week 24)
- HbA1c levels(Week 24)
- Fasting glucose levels(Week 24)
- IPAQ (international physical activity questionnaire) score(Week 24)
- low-density lipoprotein cholesterol(Week 24)
- mean daily step count after 12 weeks of intervention(Week 12)
- Body weight(Week 24)
- Blood pressure(Week 24)
- Triglycerides(Week 24)
- the proportion of patients who reach participant-day during the 12 weeks of intervention(Week 12)
- mean daily step count at Week 24(Week 24)
- the proportion of patients who reach participant-day during the Week 13-24(Week 24)
- number of recordings on personal health record application(Week 24)
- Total cholesterol(Week 24)
研究者
Jae Hyeon Kim
Professor
Samsung Medical Center