Continuous Glucose Monitoring (POC) in the ICU

This study has been terminated.
(The device selected for this study required modifications and there were no other FDA-approved glucose monitoring devices that met the needs of the study.)
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00464386
First received: April 20, 2007
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Burns
Trauma
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: September 2006
Estimated 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
Active Comparator: Continuous Glucose Monitoring + POC Glucose Testing 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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00464386

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

Publications:
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00464386     History of Changes
Other Study ID Numbers: H-06-011
Study First Received: April 20, 2007
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
Severe burns
Severe Trauma
Closed loop insulin
continuous glucose monitoring

ClinicalTrials.gov processed this record on September 18, 2014