Continuous Glucose Monitoring in Critically Ill Surgical Patients

This study has been completed.

Sponsor:

Collaborator:

Medtronic

Information provided by (Responsible Party):

Yale University

ClinicalTrials.gov Identifier:

NCT01108640

First received: April 7, 2010

Last updated: June 13, 2014

Last verified: June 2014

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

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


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)

Groups/Cohorts
Elective surgical patients
Massive resuscitation patients
surgical patients on pressors

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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 ClinicalTrials.gov identifier: 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

Publications:

Schuster KM, Barre K, Inzucchi SE, Udelsman R, Davis KA. Continuous glucose monitoring in the surgical intensive care unit: concordance with capillary glucose. J Trauma Acute Care Surg. 2014 Mar;76(3):798-803. doi: 10.1097/TA.0000000000000127.


Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01108640 History of Changes
Other Study ID Numbers:	0912006043
Study First Received:	April 7, 2010
Last Updated:	June 13, 2014
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 September 29, 2016

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