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Continuous Glucose Monitoring in Critically Ill Surgical Patients

This study is currently recruiting participants.
Verified February 2012 by Yale University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01108640
First received: April 7, 2010
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Hyperglycemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Glucose Monitoring in Critically Ill Surgical Patients

Resource links provided by NLM:

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Concordance of continuous glucose monitor with standard capillary and arterial blood glucose [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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:
  • Safety of the sensor in terms of infection or bleeding at the insertion site [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    The monitor insertion site will be observed by the bedside nurse for infectious or bleeding complications


Estimated Enrollment: 45
Study Start Date: April 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elective surgical patients
Massive resuscitation patients
surgical patients on pressors

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108640

Contacts
Contact: Kevin M Schuster, MD 203-785-2572 kevin.schuster@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Kevin M Schuster, MD     203-785-2572     kevin.schuster@yale.edu    
Sponsors and Collaborators
Yale University
Medtronic
Investigators
Principal Investigator: Kevin M Schuster, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01108640     History of Changes
Other Study ID Numbers: 0912006043
Study First Received: April 7, 2010
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013