The Effect of Remote Self-monitoring of Blood Glucose (SMBG) Combined With the Promotion and Application of Internet Mobile Terminal (APP) on the Improvement of the Staged Type 2 Diabetes Mellitus (T2DM) Management and the Success Rate of Blood Glucose in the Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- absolute change in % HbA1c from baseline to 12 months
研究概览
简要总结
To investigate whether strengthen community diabetes patients self-monitoring of blood glucose can improve the patient's blood glucose control under Chinese guidelines for the prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health and economic benefits.
详细描述
This project is a cohort intervention study for randomized controlled trials. Community health service centers are the main body of implementing treatment and community diabetes patients are the objects of intervention. 498 T2DM patients with poor blood glucose control (7%<HbA1c≤9.5%) from 4 different community health service centers will be randomized into two groups (strengthen group and control group). Strengthen self-monitoring of blood glucose by APP is the intervention and its duration is 12 months. Follow-up time of this study is 24 months (12 months after the intervention stopped). The diabetes treatment of patients from both groups follows Chinese guidelines (CDS 2017).
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 Diabetes
- •Between 18 and 79 years old
- •7.0%<HbA1c ≤ 9.5%
- •Routinely uses a smart phone
- •Capability of operating the designated APP
- •Long-time residents in Jiading District, Shanghai, China
- •Subordinated to Shanghai medical insurance
- •Contracted residents of community in Jiading District, Shanghai, China
- •Being cognitively able to participate
- •Provision of written informed consent
排除标准
- •Type 1 diabetes, gestational diabetes mellitus or other types of diabetes mellitus
- •Currently pregnant or contemplating pregnancy within the next 24 months
- •Lactating women
- •Was not able to insist until the end (24 months)
- •Cognitive impairment
- •Migrant population
结局指标
主要结局
absolute change in % HbA1c from baseline to 12 months
时间窗: baseline to 12 months
absolute change in glycemic control (% HbA1c) from baseline to 12 months
次要结局
- change in blood glucose from baseline to 24 month(baseline to 24 months)
- absolute change in % HbA1c from baseline to 6 months(baseline to 6 months)
- absolute change in % HbA1c from baseline at 24 months(baseline to 24 months)
- change in blood glucose from baseline to 6 month(baseline to 6 months)
- change in blood glucose from baseline to 12 month(baseline to 12 months)
研究者
Yuwen Zhang
Principal Investigator
Ruijin Hospital