NCT01885546已完成不适用
Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- User's ability to obtain the enhanced meter feature
研究概览
简要总结
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professionals and can remind patients of the importance of glycemic control.
This study will evaluate a user's ability to obtain the enhanced meter feature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type I or type II diabetes inclusive of the following populations:
- •Mixed insulin therapies
- •Basal insulin therapies
- •Continuous subcutaneous insulin infusion therapies
- •Multiple daily injection therapies
- •Non-insulin diabetic treatments (oral and injectable)
- •Life style (exercise and diet) diabetes management
- •New diagnosis of diabetes
- •Non diabetics
- •Able to speak and read English proficiently
- •Subjects must be willing to:
- •once a month, perform a 7 point blood glucose profile over the course of one day
- •perform fasting blood glucose tests every day
- •complete baseline and follow-up questionnaires
- •consent to baseline HbA1c assays
排除标准
- •Hct <20 or >60
- •Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott)
- •Incarcerated
- •Mentally ill
- •Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.
- •Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
研究组 & 干预措施
Enhanced meter feature usability
Other
Home diabetes monitoring by patient using provided blood glucose monitoring system.
干预措施: AgaMatrix Blood Glucose Monitor (Device)
结局指标
主要结局
User's ability to obtain the enhanced meter feature
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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