A New Glucose Meter With Alternative Site Testing
2016年9月29日 更新者：Ascensia Diabetes Care
Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]
The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).
研究概览
详细说明
The blood glucose monitoring system may be used for alternative site testing.
The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP.
Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features.
User feedback about the system and its features was obtained.
研究类型
介入性
注册 (实际的)
50
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
-
-
Michigan
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Kalamazoo、Michigan、美国、49007
- Jasper Clinic, Inc.
-
-
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
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Have type 1 or type 2 diabetes
- Be >18<76 years of age at time of consent, with approximately 50% (+10%) being less than 55 years of age
- 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
Exclusion Criteria:
- 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
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 |
|---|---|
|
其他：Subjects with diabetes
Subjects with diabetes use a new Apollo Blood Glucose Monitoring System with blood obtained from the palm and forearm
|
Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm.
These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.
其他名称：
|
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 AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results
大体时间：One hour
|
Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP
|
One hour
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants Rated as <=3 (Labeling Comprehension)
大体时间：One hour
|
Study staff rated participants as to their success at performing meter testing. The rating scale was:
|
One hour
|
|
Percentage of Participant Ratings for Overall Testing Experience With This Meter
大体时间：One hour
|
Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system).
The rating scale was 0 (Unacceptable) to 4 (Excellent).
|
One hour
|
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：Vimala Sethy, MD, PhD、Jasper Clinic, Inc.
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11月1日
初级完成 (实际的)
2008年11月1日
研究完成 (实际的)
2008年11月1日
研究注册日期
首次提交
2008年11月24日
首先提交符合 QC 标准的
2008年11月24日
首次发布 (估计)
2008年11月25日
研究记录更新
最后更新发布 (估计)
2016年11月3日
上次提交的符合 QC 标准的更新
2016年9月29日
最后验证
2016年9月1日
更多信息
与本研究相关的术语
其他研究编号
- CTD-2008-19
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
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.