NCT01455064已完成不适用
FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Clarke Error Grid Analysis
研究概览
简要总结
This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.
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
- •The subject must:
- •Have type 1 or 2 diabetes for at least 2 years prior to enrollment.
- •Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment.
- •Be at least 18 years of age.
- •Be able to read and understand English.
- •In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- •Be available for all study visits.
- •Be willing to provide written signed and dated informed consent.
排除标准
- •The subject must not:
- •Be pregnant or likely to become pregnant during the study duration.
- •Have skin abnormalities at the insertion sites.
- •Have known allergy to medical grade adhesive or skin disinfectant.
- •Be using a continuous glucose monitor currently or within the past 6 months
- •Have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject.
- •Be participating in another clinical trial.
结局指标
主要结局
Clarke Error Grid Analysis
时间窗: 15 days sensor wear
Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.
次要结局
未报告次要终点
研究者
研究点 (2)
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