This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Continuous Glucose Monitoring in Critically Ill Surgical Patients

This study has been completed.
Information provided by (Responsible Party):
Yale University Identifier:
First received: April 7, 2010
Last updated: June 13, 2014
Last verified: June 2014
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.


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

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 ]
    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 ]
    The monitor insertion site will be observed by the bedside nurse for infectious or bleeding complications

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Elective surgical patients
Massive resuscitation patients
surgical patients on pressors

  Show Detailed Description


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01108640

United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Principal Investigator: Kevin M Schuster, MD Yale University
  More Information

Responsible Party: Yale University Identifier: NCT01108640     History of Changes
Other Study ID Numbers: 0912006043
Study First Received: April 7, 2010
Last Updated: June 13, 2014

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases processed this record on June 22, 2017