Dario Blood Glucose Monitoring System - Android Devices User Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"
研究概览
简要总结
The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.
详细描述
The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has Type 1 or Type II diabetes
- •Subject speaks and reads English proficiently
- •Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study)
排除标准
- •Subject has medical training or works in the field of blood glucose monitoring systems.
- •Subject is critically ill.
- •Subject has an impairment that prevents him/her from following the study procedures.
- •Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
- •Hematocrit levels outside the range of 20%-60%.
结局指标
主要结局
Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"
时间窗: 1 Day
Using a scale of 1-5 where 1-very hard, 2-hard, 3-average, 4-easy, 5-very easy. An average rank of 3 ('average') or above in question #3 - How easy was it to operate the Dario™ BGMS on the first time?
Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?"
时间窗: 1 Day
The acceptance criteria for this question is: at least ninety percent (90%) need to answer 'Yes' on question #1 - Did you successfully obtain measurement result using the Dario™ BGMS? 100% of subjects (102 of 102) answered "Yes" to this question.
Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS"
时间窗: 1 Day
Using a scale of 1-5 where 1-completely fails, 2-unsuccessful, 3-Partially successful, 4-successful, 5-very successful. Average rank of 3.5 ('average'/'successful') or above in question #2 - How would you rate your success in operating Dario™ BGMS?
Accuracy of Glucose Concentrations (%)
时间窗: 1 Day
Accuracy acceptability is defined as follows: Ninety-five percent (95%) of the individual glucose results shall fall within +/-15 mg/dL of the results of the Dario's measurement at glucose concentrations \< 75 mg/dL and within +/- 20% at glucose concentrations greater than or equal to 75 mg/dL. The accuracy of the Dario Blood Glucose Monitoring System when used with Android operating system smart mobile devices was assessed against the Yellow Springs Instrument 2300 STAT Plus.
次要结局
未报告次要终点