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Continuous Glucose Monitoring in Critically Ill Surgical Patients

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ClinicalTrials.gov Identifier: NCT01108640
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : June 16, 2014
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
The specific aim of this study is to identify the degree of correlation between real time subcutaneous glucose monitoring and intermittent glucose monitoring using capillary glucose samples, arterial blood samples and venous blood samples in critically ill surgical patients. A secondary aim will be to determine the accuracy of real time glucose monitoring.

Condition or disease
Hyperglycemia

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Study Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Glucose Monitoring in Critically Ill Surgical Patients
Study Start Date : April 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012
Groups and Cohorts
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Group/Cohort
Elective surgical patients
Massive resuscitation patients
surgical patients on pressors


Outcome Measures
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Primary Outcome Measures :
  1. Concordance of continuous glucose monitor with standard capillary and arterial blood glucose [ Time Frame: 9 months ]
    Data from each sensor will be downloaded and blood glucose values obtained using proprietary software from Medtronic. Because the CGMS system records glucose readings every 5 minutes, capillary or arterial glucose samples obtained will be compared with the closest CGMS reading within 2.5 minutes of the time the sample was obtained. This will generate a set of paired glucose levels for analysis.


Secondary Outcome Measures :
  1. Safety of the sensor in terms of infection or bleeding at the insertion site [ Time Frame: 9 months ]
    The monitor insertion site will be observed by the bedside nurse for infectious or bleeding complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to a surgical intensive care unit and falling into one of the three groups
Criteria

Inclusion Criteria:

  • Septic surgical patients,
  • Surgical patients undergoing massive resuscitation,
  • Elective surgical patients.

Exclusion Criteria:

  • Pregnancy,
  • No safe location to place a sensor (skin disorder in areas of potential placement, minimal subcutaneous tissue),
  • Patient/surrogate declines to participate,
  • Patients speaking a language other than English or Spanish.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108640


Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Medtronic
Investigators
Principal Investigator: Kevin M Schuster, MD Yale University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01108640     History of Changes
Other Study ID Numbers: 0912006043
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
 Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases