- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00464386
Continuous Glucose Monitoring (POC) in the ICU (POC)
April 28, 2016 updated by: United States Army Institute of Surgical Research
Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU)
The purpose of this study is to prospectively evaluate whether the addition of continuous glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
Severe burns and traumatic injury can be associated with protracted illness and prolonged ICU course.
The beneficial effects of strict serum glucose control in critically ill surgical patients have been demonstrated.
Continuous glucose monitors may improve glucose control by providing close to real-time glucose measurements, giving the critical care team the ability to react to trends before hypo- or hyperglycemia is reached.
These improvements may decrease the morbidity and mortality associated with severe thermal injury, thereby minimizing hospital stay and recovery.
Burned and injured soldiers, airmen, sailors, and marines may return to duty in a more expeditious fashion, or at minimum, enjoy a better quality of life after discharge from the intensive care unit.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- US Army Institute of Surgical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 72 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- remain 1 week in an ICU
- 18-72 years old
- severe trauma or thermal injury greater than 20% TBSA burn
Exclusion Criteria:
- cerebral arterial injury
- myocardial infarction
- pre-existing renal failure or liver failure
- history of hypoglycemia
- history or high risk of seizures
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: POC Glucose Testing
Hourly blood glucose monitoring with point of care glucometer (i.e., current standard of care).
|
|
EXPERIMENTAL: Continuous Glucose Monitoring
Continuous arterial glucose monitoring with Guardian sensor + hourly blood glucose monitoring with point of care glucometer (i.e., current standard of care).
|
measure glucose levels on burn patients
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To prospectively evaluate the reliability of continuous glucose monitors and the advisability of their use in patients with severe trauma and or thermal injury.
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control.
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Heather Pidcoke, MD, US Army Institute of Surgical Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (ACTUAL)
February 1, 2009
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
April 20, 2007
First Submitted That Met QC Criteria
April 20, 2007
First Posted (ESTIMATE)
April 23, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
May 2, 2016
Last Update Submitted That Met QC Criteria
April 28, 2016
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- H-06-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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