NCT00920881已完成不适用
Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 3
研究概览
简要总结
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •History consistent with type 1 diabetes
- •At least 18 years of age
- •Available and capable of following the protocol instructions provided by the healthcare professional
- •Signed and dated informed consent form
排除标准
- •Pregnancy
- •Type 2, gestational, or secondary diabetes
- •Known allergy to medical grade adhesives
- •Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
- •Seizure disorder
- •Myocardial ischemia
- •History of stroke
- •Severe hypoglycemia unawareness
- •Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety
研究者
研究点 (3)
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