NCT03433573已完成不适用
Paediatric Use of the Abbott Sensor Based Glucose Monitoring System - an Accuracy Evaluation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 22
- 主要终点
- Point Accuracy Determined as % within Consensus Error Grid Zone A
研究概览
简要总结
Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-17 years (inclusive).
- •Have type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (CSII).
- •Currently testing blood glucose levels at least twice per day.
- •Each participant has an identified Caregiver aged ≥18 years.
- •In the investigator's opinion, technically capable of using device (participant and/or caregiver).
排除标准
- •Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition.
- •Currently prescribed oral steroid therapy for any acute or chronic condition.
- •Currently receiving dialysis treatment or planning to receive dialysis during the study.
- •Female participant known to be pregnant.
- •Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
- •Currently using a real-time or professional use continuous glucose monitoring (CGM) or FreeStyle Libre device or is planning to use one during the study, and unwilling to stop use of the device during the study.
- •Known (or suspected) allergy to medical grade adhesives.
- •In the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered).
结局指标
主要结局
Point Accuracy Determined as % within Consensus Error Grid Zone A
时间窗: Up to 35 days
Point accuracy of Sensor based glucose values compared to capillary fingerstick blood glucose, determined as % within Consensus Error Grid Zone A.
次要结局
未报告次要终点
研究者
研究点 (22)
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