Labeling Comprehension and Performance Evaluation of the Apollo Blood Glucose Monitoring System With Capillary Blood [Commercial Name is CONTOUR® USB]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Percentage of Participants Rated as <=3 (Comprehension of Labeling)
研究概览
简要总结
The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).
详细描述
The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide and Quick Reference Guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. The study also evaluated the performance of the blood glucose meter system (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects and healthcare professionals provided feedback about the BGMS and its features. Some subjects took the system home to evaluate the robustness of the BGMS.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 1 or type 2 diabetes
- •Be at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent
- •Be willing to complete all study procedures
- •Be routinely testing their blood sugar at home (at least once per day)
- •Be able to speak, read, and understand English and understand the Informed Consent document
- •Be able to read the labeling instructions
- •Own or operate a computer for personal or professional use beyond that for email correspondence. Subjects will not have to use their personal computer for the study, but computer use will be required.
排除标准
- •Minors <18 years of age and adults >75 years of age
- •Pregnancy
- •Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
- •Disorders in the fingertip lancing areas
- •Acute or chronic infections, particularly skin infections
- •Infection with a blood borne pathogen
- •Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion
- •Hemophilia or any other bleeding disorder
- •Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
- •Working for a competitive medical device company
结局指标
主要结局
Percentage of Participants Rated as <=3 (Comprehension of Labeling)
时间窗: 1-2 hours
Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was: 1. Successful in performing tasks correctly without assistance 2. Successful after being referred to user instructions 3. Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
次要结局
- Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method(1-2 hours)