NCT00806858已完成不适用
NovoPen®4 Clinical Experience Programme: A Multicentre, Observational Study of NovoPen®4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 1
- 主要终点
- The change in subjects' satisfaction with insulin therapy, measured by change from visit 1 to visit 2 in subject treatment satisfaction scores on the DTSQ (Diabetes Treatment Satisfaction Questionnaire)
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen®
- •The selection will be at the discretion of the individual physician.
- •A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations
排除标准
- •Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit
- •Subjects with known or suspected allergy to any insulin or any of its excipients
结局指标
主要结局
The change in subjects' satisfaction with insulin therapy, measured by change from visit 1 to visit 2 in subject treatment satisfaction scores on the DTSQ (Diabetes Treatment Satisfaction Questionnaire)
时间窗: 3 months
次要结局
- Subjects' device preference(3 months)
- Subjects' NovoPen® 4 evaluation(3 months)
- Number of clinical technical complaints(3 months)
研究者
研究点 (1)
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