NCT00333853已完成不适用
Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm) to Improve Glycemic Control Through Behavioral and Therapeutic Changes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeScan
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing. Effective presentation and data analysis are essential. We examined HbA1c changes using the OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (Control Group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with type 1 or type 2 insulin-treated diabetes mellitus with a baseline HbA1c greater than or equal to 8.0%.
- •The lower age limit for pediatric subjects was at the discretion of the pediatric investigators and their Institutional Review Board (IRBs).
- •The upper age limit for pediatric subjects was 20 years (i.e., not having reached their 21st birthday on date of enrollment).
- •Subjects must have monitored blood glucose at least 2 times per day. - Subject's current blood glucose meter has download capability, however, the subject did not routinely use this capability on his/her own.
排除标准
- 未提供
结局指标
主要结局
Hemoglobin A1c (HbA1c)
次要结局
- Measured hypoglycemia
研究者
研究点 (14)
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