NCT00401622已完成不适用
Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeScan
- 入组人数
- 320
- 试验地点
- 18
- 主要终点
- Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
研究概览
简要总结
Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of type 2 diabetes
- •Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
- •Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
- •Baseline HbA1c of 7.0 to 8.9%, inclusive
排除标准
- •Using insulin
- •Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
- •Known history of anemia or disorders associated with anemia
- •Has previously used the devices being tested in the study
研究组 & 干预措施
OneTouch® Ultra®2 system
Experimental
Test care group assigned to OneTouch® Ultra®2 system
干预措施: OneTouch® Ultra®2 System (Behavioral)
Standard care
Active Comparator
Control group receiving standard care with a traditional blood glucose monitoring system
干预措施: Standard care (Behavioral)
结局指标
主要结局
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
时间窗: From baseline to 52 wks
次要结局
- Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.(52 wks)
研究者
研究点 (18)
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