NCT01024218已完成4 期
An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Device preference
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants. The trial consists of a handling test followed by a 12 week cross-over study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks
- •Participants must demonstrate proficiency with the injection device in the handling test prior to testing the NovoFine® Autocover™ Needle in patients
排除标准
- 未提供
结局指标
主要结局
Device preference
时间窗: after 12 weeks
次要结局
- Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects)
- Comparison of the frequency of adverse device effects
- Comparison of the frequency of adverse events (needle stick injuries)
研究者
研究点 (2)
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