NCT01327209已完成不适用
Blood Glucose Monitoring System Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 4
研究概览
简要总结
Verify the following with blood glucose monitoring system:
- precision and accuracy versus YSI reference
- user evaluation
- labeling comprehension
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with Diabetes
- •Be between 12 and 70 years of age
- •Be able to read, write, and understand English
- •Be able and willing to give Informed Consent
- •Have used an SMBG meter system for at least one year
- •Be currently testing blood glucose levels at least once per day
排除标准
- •Inability to provide Informed Consent
- •Subject does not meet Inclusion Criteria
- •Subject does not agree to test for infectious diseases per clinical protocol
- •Subject has minimally one positive test for any infectious disease listed under Exclusion Criteria per protocol
- •Subject with any condition (in addition to those which are listed in the pre-screen Exclusion Criteria tests) which in the opinion of the Investigator may place the subject or site personnel at excessive risk
- •Subject's physical condition/limitation prevents the person from using a BGMS on their own
研究者
研究点 (4)
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