In-Clinic Evaluation of the Redwood A1c Test Kit With Lay-Users and Professionals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)
研究概览
简要总结
The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.
详细描述
The purpose of this study was to assure that consumers could successfully use the new version of A1CNow+ Test Kit along with revised instructional materials. The primary objective was to establish accuracy and secondary objectives were to establish precision, comprehension of instructional materials, and user feedback about the overall testing experience.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (age 18 and older) approximately 80% being ≤55 years old
- •Persons with:
- •known diabetes (type 1 or type 2) and pre-diabetes - approximately 85% of subject population per site
- •no known diagnosis of diabetes - approximately 15% of subject population per site
- •Individuals who are interested in performing a test using the kit at home
- •Individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures)
- •Individuals who are able to speak, read, and understand English
- •Individuals able to read out loud the first 5 lines of the A1C Test Kit instructional materials to demonstrate ability to read the print (may use glasses, if needed)
排除标准
- •Individuals taking prescription anticoagulants (such as Warfarin or heparin) or have clotting problems that may prolong bleeding. (Taking Plavix or aspirin daily is not excluded)
- •Individuals with known Rheumatoid Arthritis or other condition causing significant impairment of manual dexterity
- •Individuals with a known hemoglobin variant such as HbS or HbC
- •Individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia)
- •Individuals who have received a blood transfusion within the 4 months prior to the study.
- •Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis)
- •Individuals working for a competitive medical device company
- •Individuals who have participated in previous studies on the A1CNow+ product
- •Persons missing a digit or partial digits on the hand
- •Individuals with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
- •Significant visual impairment
- •Significant hearing impairment
- •Cognitive disorder
- •Any other condition as per investigator's discretion
研究组 & 干预措施
Subjects with and without Diabetes
Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
干预措施: A1C Test Kit (Device)
结局指标
主要结局
Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)
时间窗: One hour
This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.
次要结局
- Average Within Subject Coefficient of Variation CV (PRECISION)(One hour)
- Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing(One hour)
- Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit(One hour)