User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Enhanced Meter Feature Usability
研究概览
简要总结
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.
This study will evaluate a user's ability to use 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
- •Age of subject is 18 years or older
- •Type I or type II diabetes inclusive of the following populations:
- •Mixed insulin therapies
- •Basal insulin therapies
- •Bolus insulin therapies
- •CSII therapies
- •MDI therapies
- •Non-insulin diabetic treatments (oral and injectable)
- •Life style (exercise and diet) diabetes management IC
- •Able to speak and read English proficiently
排除标准
- •Pregnant EC
- •Hct <20 or >60 EC
- •Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC
- •Homeless EC
- •Incarcerated EC
- •Institutionalized EC
- •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.
- •Previous experience using the MyStar Extra BGMS
研究组 & 干预措施
Enhanced meter feature usability
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
Enhanced Meter Feature Usability
时间窗: 4 weeks
The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).
次要结局
未报告次要终点