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Continuous Glucose Monitoring (POC) in the ICU (POC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00464386
Recruitment Status : Terminated (Study device required infeasible modifications. No patients received device.)
First Posted : April 23, 2007
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):
United States Army Institute of Surgical Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Burns Trauma Device: Continuous Glucose Monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU)
Study Start Date : September 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Dextrose

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).
Device: Continuous Glucose Monitoring
measure glucose levels on burn patients
Other Name: Guardian continuous glucose monitor

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control. [ Time Frame: 90 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00464386

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United States, Texas
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
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Principal Investigator: Heather Pidcoke, MD US Army Institute of Surgical Research
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Responsible Party: United States Army Institute of Surgical Research Identifier: NCT00464386    
Other Study ID Numbers: H-06-011
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: February 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by United States Army Institute of Surgical Research:
Severe burns
Severe Trauma
Closed loop insulin
continuous glucose monitoring