NCT01130480已完成不适用
Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 833
- 试验地点
- 19
- 主要终点
- HbA1c change between the baseline and end of study
研究概览
简要总结
COMPASS is a status and intervention study for the self-monitoring of blood glucose (SMBG) in type 2 diabetic patients with insulin treatment. This multi-centre, open-label prospective study will assess the use and frequency of SMBG and blood glucose control and its influencing factors with the help of Accu-Chek Integra glucometer. Patients with type 2 diabetes mellitus who have received more than 3 months of insulin therapy are eligible to participate in this study. The anticipated duration of the study is 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II diabetes mellitus patients who have received insulin treatment for more than 3 months
- •Patients willing to sign written informed consent form
- •Patients who meet the criteria for the first cross-sectional investigation and have an HbA1c < 7% will receive the second cross-sectional investigation
排除标准
- •Patients unable or unwilling to comply with the requirements of the protocol
结局指标
主要结局
HbA1c change between the baseline and end of study
时间窗: From baseline to month 6
Successful rate of blood glucose control (the proportion of patients with HbA1c <7%)
时间窗: From baseline to month 6
次要结局
- To evaluate the change of quality of life in the 6 months by the health questionnaire SF-36(From baseline to month 6)
- SMBG frequency change between the baseline and the end of the study(From baseline to month 6)
- Relationship between SMBG frequency change and blood glucose control(From baseline to month 6)
研究者
研究点 (19)
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