NCT01631643撤回4 期
One Touch® Verio®IQ European Clinical Outcomes Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- LifeScan
- 主要终点
- Change in A1C from baseline to week 24
研究概览
简要总结
Evaluation of the clinical benefits of One Touch VerioIQ system.
详细描述
Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female at least 18 to 80 years old
- •ADA guidelines for FPG and PPG appropriate
- •A1C greater or equal to 8.0% and less than or equal to 10.5%
- •lab A1C greater than or equal to 8.0% in the last 6-12mths
- •Diagnosed with type 1 or 2 in at least last 1 year
- •on stable dose of OADs for at least 3mths prior to screening
- •willingness to test 7 BGM tests per day
- •willing to remain on same therapy as baseline (MDI) for duration of study
排除标准
- •unlikely to be compliant to study procedures
- •has or has currently used One Touch VerioIQ
- •Is on fixed doses of insulin for MDI therapy
结局指标
主要结局
Change in A1C from baseline to week 24
时间窗: 24 weeks
A1C (also known as hemoglobin A1C or glycosylated hemoglobin)
次要结局
- Change in A1C from baseline to week 12(12 weeks)
- Change in FPG from baseline to 24 weeks(24 weeks)
- Change in proportion of subjects with A1C less than or equal to 7.0% at week 24(24 weeks)
- Change in 30 day mean glucose comparing first month to last month after 24 weeks(24 weeks)
研究者
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