NCT07052292已完成不适用
DuraTouch® - Post-Market Clinical Follow-up (PMCF) Study in a Real-world Setting
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 11
- 主要终点
- Participant rating the ease of use, convenience and satisfaction with the device
研究概览
简要总结
This study looks at overall impact of the use of DuraTouch® in terms of ease, convenience to use and satisfaction in participants with either type 1 or type 2 diabetes.The study will last for about 12 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The decision to initiate treatment with DuraTouch® has been made by the participant/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
- •All needed signed consent(s) are obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Mental incapacity (when no caregiver and LAR are assigned to the patient), unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
DuraTouch® (Insulin injection)
Participants will subcutaneously inject the insulin prescribed by the doctor using DuraTouch® according to routine clinical practice at the discretion of the treating physician.
干预措施: DuraTouch® (Device)
结局指标
主要结局
Participant rating the ease of use, convenience and satisfaction with the device
时间窗: At week 12
Rating score on a 5-point Likert-type response scale. 1=Not at all easy/convenient/satisfied, 5=Extremely easy/convenient/satisfied.
次要结局
- Participant rating the ease of preparing the device for use and ease of injection(At week 12)
- Participant rating the confidence of using the device correctly and confidence in the device delivering the correct full dose(At week 12)
- Participant rating ease to learn how to use the device(At week 12)
研究者
研究点 (11)
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