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

Study Overview
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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.

Detailed Description
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Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following: Device Performance: Functionality of HGMS Alerts/Alarms Specificity and Sensitivity System Workflow 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

Official Title
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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

Conditions
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Hyperglycemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years old Subject is admitted to the ICU Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl 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 Subject has anticipated life expectancy greater than 96 hours Subject has recent platelet count greater than 30,000 per micro-liter Exclusion Criteria: 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 Subject is currently participating in another investigational drug or device study Subject is pregnant, as determined by hospital admission Subject is receiving treatment that includes Hydroxyurea.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Performance: Accuracy of HGMS | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medtronic, Diabetes, Hospital, Continuous Glucose Monitor, Intensive Care Unit