User Performance of the L-PLUS Blood Glucose Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test
研究概览
简要总结
L-PLUS (Lightning PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and marketed CONTOUR PLUS® test strip. This clinical trial will assess the performance (accuracy) of the L-PLUS meter by lay users with diabetes enrolled as subjects in the study, and by health care professionals (also called study staff).
The trial will follow the requirements and procedures described in ISO 15197:2013 International Standard.
详细描述
This study is designed to satisfy the ISO 15197:2013, Section 8 requirements.
The study will be conducted at a minimum of one clinical site and enroll a total of approximately 130 persons with diabetes.
For this study, there must be at least 120 evaluable results each for fingerstick and AST self-test results, as well as for staff testing subject fingertip and venous blood using the L-PLUS BGMS. Subject enrollment will continue until the required evaluable samples are collected.
The subjects will be 18 years and older. Each subject will make one visit, lasting approximately 1 hour at the clinical site. All subjects will complete the informed consent process before performing any study procedures.
All Subjects will be assigned a L-PLUS meter and one Contour Plus test strip lots. The untrained subjects will learn to use the L-PLUS meter by reading the instructional materials. Each subject will perform one fingerstick self-test, one palm test, and staff will perform a fingerstick test on the subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Males and females, 18 years of age and older
- •People with diabetes (PWD) - type 1 or type 2
- •Ability to speak, read and understand English. Subjects must demonstrate ability to read a paragraph from the first page of the UG to qualify for the study.
- •Willing to complete all study procedures
排除标准
- •Hemophilia or any other bleeding disorder
- •Pregnancy (self-reported)
- •Physical, visual or neurological impairments that would make the person unable to perform testing with the BGMS.
- •Previous participation in a blood glucose monitoring study using the Ascensia's Contour Next (Lightning Next) and Lightning PLUS (L-PLUS or Contour Plus ELITE) BGMS.
- •Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose monitors.
- •Being in this trial during or less than two days since xylose absorption testing (Xylose in the blood is known to cause interference).
- •Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
- •A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk. The reason for exclusion will be clearly documented by investigator or designee on the subject disposition form.
研究组 & 干预措施
Untrained Subjects with Diabetes use the L-PLUS BGMS
Untrained subjects with Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the L-PLUS BGMS. All blood glucose results are compared to reference method results obtained with subject capillary plasma. Also, study staff test venous blood and blood glucose results are compared to reference method results obtained from subject venous plasma.
干预措施: L-PLUS meter (Device)
结局指标
主要结局
Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test
时间窗: Day 1
Accuracy of BGMS test with fingerstick blood. The results of the fingerstick meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria.
次要结局
- Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood(Day 1)
- Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST)(Day 1)