US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 8
- 主要终点
- User Performance ( UP)
研究概览
简要总结
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).
详细描述
User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C.
Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.
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
- 否
入选标准
- •Summary of inclusion criteria:
- •Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group.
排除标准
- •Conflict of interest. Technical expertise.
研究组 & 干预措施
Blood Glucose monitoring System (BGMS)
Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300)
干预措施: New BGMS (US) (Device)
结局指标
主要结局
User Performance ( UP)
时间窗: < 30 minutes
User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument.
System Use Evaluation
时间窗: < 30 minutes
System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire.
次要结局
未报告次要终点