NCT01745549已完成不适用
Efficacy, Safety and Satisfaction of the New Pen Needle 33G x 4 mm 33G x 4 mm: Cross-over Randomized Controlled Clinical Trial. Studio AGO 01
Consorzio Mario Negri Sud8 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 8
- 主要终点
- hematic fructosamine levels
研究概览
简要总结
During the last years, even more little needles are used for the injection of sub cutaneous insulin, for the diabetes therapy.
The aim of this study is to evaluate the non inferiority of a new needle, smaller than another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.
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
- •both males and females
- •age >=18 anni
- •insulin treatment from at least 6 months
- •signed informed consent
排除标准
- •pregnancy
- •incapacity for filling in the questionnaires
- •every illness or condition that, according to the investigator, could interfere with the study
结局指标
主要结局
hematic fructosamine levels
时间窗: Change from baseline in fructosamine levels after 3 weeks of treatment
次要结局
- mean amplitude of glucose excursions (MAGE)(Change from baseline in MAGE after 3 weeks of treatment)
- pain(questionnaire at the end of the treatments (at 6 weeks))
- leakage at the site injection(number of episodes of leakage during the treatment (3 weeks))
- hypoglycemia(number of episodes of hypoglycemia during the treatment (3 weeks))
- insulin dosage(Change from baseline in insulin dosage after 3 weeks of treatment)
- patient's weight(Change from baseline in weight after 3 weeks of treatment)
- patient's satisfaction(questionnaire at the end of the treatments (at 6 weeks))
研究者
Antonio Nicolucci
Dr Antonio Nicolucci, MD
Consorzio Mario Negri Sud
研究点 (8)
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