POGO® Automatic Blood Glucose Monitoring System Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 2
- 主要终点
- Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.
研究概览
简要总结
The purpose of this study is to determine if the POGO® system delivers accurate blood glucose readings in the hands of the lay user and assess the POGO® system accuracy when used by trained health care professionals.
详细描述
Subjects will review labeling materials and self-test using the POGO® system. An HCP-assisted test also will be performed; both tests will be compared to a fingerstick capillary sample run on a YSI reference glucose analyzer. Subjects will complete questionnaires on labeling comprehension and POGO® usability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with diabetes
- •Be 18 years of age or older
- •Be able to read, write, and understand English fluently
- •Be able and willing to give written informed consent and have provided signed, written consent
排除标准
- •Any condition which in the opinion of the Investigator may place the subject or site personnel at excessive risk
- •A physical condition or limitation that prevents the subject from reading the labeling and using a BGMS on their own
- •Previous experience with the POGO® BGMS
- •Formal experience with clinical (medical) laboratory equipment or formal training in a relevant medical field
结局指标
主要结局
Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.
时间窗: Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)
Lay-user accuracy
Accuracy Verification of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.
时间窗: Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)
HCP accuracy
次要结局
未报告次要终点