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Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS) (MAHI)

2015年5月5日 更新者：Medtronic Diabetes

A Multi-Phased, Multi-Center Study to Evaluate Safety and Device Performance of the Medtronic Hospital Glucose Management System (HGMS) in Critically Ill Adult Patients

The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.

研究概览

地位

完全的

条件

详细说明

Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:

  1. Device Performance:

    • Functionality of HGMS
    • Alerts/Alarms Specificity and Sensitivity
    • System Workflow

  2. Safety:

    • Descriptive statistics will be used to characterize safety events
    • Moderate and severe anticipated device and procedure related adverse events
    • All serious adverse events and unanticipated adverse device effects related events

研究类型

观察性的

注册 (实际的)

19

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

  • 美国
    • Missouri
      • Kansas City、Missouri、美国、64111
        • St Luke's Hospital Mid America Heart Institute

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 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult patients admitted to the Intensive Care Unit (ICU) and on intravenous (IV) insulin therapy for the treatment of transient or diabetes-related hyperglycemia

描述

Inclusion Criteria:

  1. Subject is at least 18 years old
  2. Subject is admitted to the ICU
  3. Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl

  4. Subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours

    a. Including patients with no previous diagnosis of Diabetes Mellitus

  5. Subject has anticipated life expectancy greater than 96 hours
  6. Subject has recent platelet count greater than 30,000 per micro-liter

Exclusion Criteria:

  1. Subject currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the subject from completing the study
  2. Subject is currently participating in another investigational drug or device study
  3. Subject is pregnant, as determined by hospital admission
  4. Subject is receiving treatment that includes Hydroxyurea.

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

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
Device Performance: Accuracy of HGMS
大体时间：up to 72 hours

Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values].

The portable i-STAT handheld makes patient-side testing easy:

  • Requires no special sample preparation or user calibration; maintenance is minimal
  • Weighs 18 ounces, making it portable
  • Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results:
  • The system prompts users step by step through the testing process
  • Operator and patient information can be entered via barcode scanner
  • Operator lockout prevents unauthorized users from performing or viewing test results
  • Test results are uploaded automatically when the i-STAT handheld is placed in a downloader
up to 72 hours

其他结果措施

结果测量
措施说明
大体时间
Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected
大体时间：up to 72 hours
The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.
up to 72 hours
Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected
大体时间：72 hours
The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.
72 hours
Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert
大体时间：Up to 72 hours
Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.
Up to 72 hours
Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert
大体时间：Up to 72 hours
Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.
Up to 72 hours

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。

赞助

Medtronic Diabetes

调查人员

  • 首席研究员：Mikhail Kosiborod, M.D、St Luke's Hospital - Mid America Heart Institute

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。

一般刊物

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

2012年3月1日

初级完成 (实际的)

2012年8月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2012年12月21日

首先提交符合 QC 标准的

2013年1月4日

首次发布 (估计)

2013年1月9日

研究记录更新

最后更新发布 (估计)

2015年5月7日

上次提交的符合 QC 标准的更新

2015年5月5日

最后验证

2015年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CEP244

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.

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