Project Frazier 3 Regulatory Clinical Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 379
- 试验地点
- 8
- 主要终点
- User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.
研究概览
简要总结
Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)
详细描述
User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Summary of Inclusion Criteria
- •Age - Subject is at least 12 years old.
- •Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
- •Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
- •Language - Subject reads and understands local language
- •SMBG status confirmed
- •Subject agrees to complete all aspects of the study
排除标准
- •Conflict of Interest
- •Pregnancy - Subject is pregnant (as confirmed by Subject)
- •User Performance Accuracy Testing - Technical Expertise
结局指标
主要结局
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. BGMSs samples collected by subject and reference samples collected by HCP ( Health Care Professional)
Instructions for Use Evaluation questionnaire.
时间窗: Up to 10 days.
Questionnaires to assess the effectiveness of the instructions for use.
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.
System Use Evaluation questionnaire
时间窗: Up to 15 minutes
Assessment of how the patient uses the BGMS.
Marketing Claims Evaluation questionnaire.
时间窗: Up to 10 days
Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.
次要结局
未报告次要终点