NCT01072565已完成不适用
Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ≥18 and ≤75 years of age
- •Clinical diagnosis of diabetes
- •Diabetes duration ≥ 1 year
- •HbA1c ≥7.2%
- •Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy
排除标准
- •Taken prednisone or cortisone medications in the previous 30 days
- •Currently pregnant or planning pregnancy during the study period
- •Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- •Unable to follow the study protocol
- •Unable to speak, read and write in English
结局指标
主要结局
Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.
时间窗: Three, six and nine months.
次要结局
- Determine the incremental benefit of CGM for clinical decision-making.(Three, six and nine months.)
研究者
研究点 (2)
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