NCT02690467Unknown不适用
Efficacy, Safety and Acceptability of the New Pen Needle 33G x 4 mm: a Cross-over Randomised Non Inferiority Trial
Center for Outcomes Research and Clinical Epidemiology, Italy6 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年9月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Fructosamine levels
研究概览
简要总结
The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin.
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
- 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
- •Patients with type 1 or type 2 diabetes
- •Age >= 18 years
- •Multiple daily injections of insulin for at least 6 months
- •Signed informed consent
排除标准
- •Pregnancy or or breast feeding
- •Inability to fill in the questionnaire
- •Combined therapy for diabetes (oral drugs associated with insulin injections)
- •Any medical condition that could interfere with the study according to the investigator's opinion
研究组 & 干预措施
Insupen G34x3,5mm
Experimental
Needle for insulin pen 3,5 mm long and with a diameter of 34 gauge
干预措施: Insupen G34x3,5mm (Device)
Insupen G32x4mm
Active Comparator
Needle for insulin pen 4 mm long and with a diameter of 32 gauge
干预措施: Insupen G32x4mm (Device)
结局指标
主要结局
Fructosamine levels
时间窗: 3 weeks
Change from baseline in fructosamine levels after 3 weeks of treatment
次要结局
- Body weight(3 weeks)
- Number of hypoglycaemia episodes(3 weeks)
- Patient satisfaction measured by a questionnaire(3 weeks)
- Number of episodes of insulin leakage at injection site(3 weeks)
- Glycemic variability expressed as the standard deviation of fasting blood and postprandial glucose levels(3 weeks)
- Daily insulin dose(3 weeks)
- Number of patients with hypoglycaemia(3 weeks)
- Pain(3 weeks)
研究者
研究点 (6)
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