Expired Study
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Kansas City, Missouri 64111


Purpose:

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.


Study summary:

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


Criteria:

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.


NCT ID:

NCT01763567


Primary Contact:

Principal Investigator
Mikhail Kosiborod, M.D
St Luke's Hospital Mid America Heart Institute


Backup Contact:

N/A


Location Contact:

Kansas City, Missouri 64111
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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