In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 8
- 主要终点
- Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results
研究概览
简要总结
The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.
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
- 4 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Age 4 to 24 years
- •Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment
- •Has used a handheld game system to play video games within a year of enrollment
- •If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.
- •Is willing to complete all study procedures, with appropriate parent/guardian supervision
排除标准
- •Hemophilia or any other bleeding disorder
- •Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
- •Infection with a blood borne pathogen (e.g., HIV, hepatitis)
- •Subject or parent/guardian is employee of competitive medical device company
- •Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
结局指标
主要结局
Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results
时间窗: 1-2 hours
Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values \<75mg/dL) and within +/- 20% (for reference BG values \>= 75mg/dL)of the HCP results was calculated.
Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
时间窗: 1-2 hours
Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values \<75mg/dL) or +/- 20% (for reference blood glucose values \>/= 75mg/dL)of the reference results were calculated.
次要结局
- Average Within Replicate Coefficient of Variation CV (Precision)(1-2 hours)
- Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies(1-2 hours)
- Number of Participants Rated as <=2 (Labeling Comprehension)(1-2 hours)