In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System
2016年1月29日 更新者：Ascensia Diabetes Care
In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults
The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.
研究概览
研究类型
介入性
注册 (实际的)
147
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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Escondido、California、美国、92026
- AMCR Institute
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Los Angeles、California、美国、90027
- Childrens Hospital Los Angeles
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Colorado
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Aurora、Colorado、美国、80045
- Barbara Davis Center
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
4年 至 24年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intended Users of the Monitoring System
Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood.
Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
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Subjects with diabetes used a new blood glucose monitoring system with capillary blood.
Certain results were compared to a laboratory glucose method.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
大体时间：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.
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1-2 hours
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Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results
大体时间：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.
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1-2 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies
大体时间：1-2 hours
|
The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results.
Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed.
Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences
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1-2 hours
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Number of Participants Rated as <=2 (Labeling Comprehension)
大体时间：1-2 hours
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Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:
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1-2 hours
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Average Within Replicate Coefficient of Variation CV (Precision)
大体时间：1-2 hours
|
The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.
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1-2 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Javier Aisenberg, MD、Hackensack Meridian Health
- 首席研究员：Georgeanna Klingensmith, MD、Barbara Davis Center
- 首席研究员：Francine Kaufman, MD、Children's Hospital Los Angeles
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年12月1日
初级完成 (实际的)
2009年3月1日
研究完成 (实际的)
2009年3月1日
研究注册日期
首次提交
2008年12月5日
首先提交符合 QC 标准的
2008年12月5日
首次发布 (估计)
2008年12月8日
研究记录更新
最后更新发布 (估计)
2016年2月29日
上次提交的符合 QC 标准的更新
2016年1月29日
最后验证
2016年1月1日
更多信息
与本研究相关的术语
其他研究编号
- CTD-2008-23
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.