Project Bloom Regulatory Clinical Evaluation - System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeScan
- 入组人数
- 174
- 试验地点
- 8
- 主要终点
- System Use Evaluation questionnaire.
研究概览
简要总结
Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Summary of Inclusion Criteria:
- •Able to voluntarily provide written informed consent to participate in the study.
- •User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
- •For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 -
排除标准
- •Female subjects who are pregnant or lactating.
- •Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
- •User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.
结局指标
主要结局
System Use Evaluation questionnaire.
时间窗: Up to 15 minutes
Assessment of how the patient uses the BGMS.
User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.
时间窗: Up to 1 hour
UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( Health Care Professional)
System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.
时间窗: Up to 1 hour
Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.
Marketing Claims Evaluation questionnaire.
时间窗: Up to 6 days.
Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.
Instructions for Use Evaluation questionnaire.
时间窗: Up to 6 days.
Questionnaires to assess the effectiveness of the instructions for use.
次要结局
未报告次要终点