NCT02824549Unknown不适用
An Evaluation of the Usability, Skin Reactions and Accuracy of the FreeStyle Libre Flash Glucose Monitoring System
Jessa Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Usability of the FreeStyle glucose monitoring systeem
研究概览
简要总结
The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system in children will be evaluated by questionnaires, pictures of the insertion site and comparison of the glucose results with capillary blood glucose determinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes mellitus
- •being followed in the Pediatric Diabetes Unit of the Jessa Ziekenhuis
排除标准
- 未提供
结局指标
主要结局
Usability of the FreeStyle glucose monitoring systeem
时间窗: 0.5 year follow-up
The usability will be evaluated by a short questionnaire.
次要结局
- Skin reactions to the sensor : e.g. allergic reaction, red mark, blister(0.5 year follow-up)
- Accuracy of the FreeStyle Libre glucose monitoring system(0.5 year follow-up)
研究者
Ingrid Arijs
Prof. dr. G. Massa, MD, PhD - Pediatric Endocrinologist
Jessa Hospital
研究点 (1)
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