Continuous Glucose Monitoring in Critically Ill Surgical Patients
1 other identifier
observational
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 7, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJune 16, 2014
June 1, 2014
2.3 years
April 7, 2010
June 13, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Concordance of continuous glucose monitor with standard capillary and arterial blood glucose
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.
9 months
Secondary Outcomes (1)
Safety of the sensor in terms of infection or bleeding at the insertion site
9 months
Study Arms (3)
Elective surgical patients
Massive resuscitation patients
surgical patients on pressors
Eligibility Criteria
Patients admitted to a surgical intensive care unit and falling into one of the three groups
You may qualify if:
- Septic surgical patients,
- Surgical patients undergoing massive resuscitation,
- Elective surgical patients.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Medtroniccollaborator
Study Sites (1)
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Related Publications (1)
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.
PMID: 24553551RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin M Schuster, MD
Yale University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2010
First Posted
April 22, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
June 16, 2014
Record last verified: 2014-06