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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hyperglycemia

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No