Individualized Management Based on Mobile Phone Platform in Diabetic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- change in glycated hemoglobin levels
研究概览
简要总结
The purpose of this study was to explore a model suitable for the individualized diabetic management based on the mobile application coaching and demonstrate its effect among the diabetic mellitus population.
详细描述
The enrolled patients will be randomly divided into three groups: group of online self management, group of online mutual management and the control group. The estimated sample size was 78 patients for each group. All the patients attend two follow-up visits at the hospital, after 3 and 6 months. The data will be collected by a full-time recorder and analyzed using specific statistical software. The enumeration data are analyzed by chi-square test, while the measurement data are analyzed by one-way ANOVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of DM for more than 6 months;
- •Glycated hemoglobin more than or equal to 8% within 3 months;
- •Age:18-65 years.
排除标准
- •Insulin pump users;
- •Pregnant;
- •Active substance, alcohol, or drug abuser;
- •Psychotic or schizophrenic under active care;
- •Severe hearing or visual impairment and other complications;
- •Drug users (such as glucocorticoid or thyroid hormone) 3 months before the enrollment;
- •No smartphone access.
结局指标
主要结局
change in glycated hemoglobin levels
时间窗: six months
次要结局
- change in lipid profile levels(six months)
- change of urinary albumin creatinine rate(six months)
- change of hepatic function(six months)
- change of blood creatine(six months)
- change of blood urea nitrogen(six months)
- change in scores measured by MKT(six months)