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

This study has been terminated.
(Study device required infeasible modifications. No patients received device.)
Information provided by (Responsible Party):
United States Army Institute of Surgical Research Identifier:
First received: April 20, 2007
Last updated: April 28, 2016
Last verified: February 2015
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 Intervention
Device: Continuous Glucose Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU)

Resource links provided by NLM:

Further study details as provided by United States Army Institute of Surgical Research:

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

Enrollment: 23
Study Start Date: September 2006
Study Completion Date: December 2013
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00464386

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
Principal Investigator: Heather Pidcoke, MD US Army Institute of Surgical Research
  More Information

Responsible Party: United States Army Institute of Surgical Research Identifier: NCT00464386     History of Changes
Other Study ID Numbers: H-06-011
Study First Received: April 20, 2007
Last Updated: April 28, 2016
Individual Participant Data  
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 processed this record on May 25, 2017