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Clinical Trials/NCT00464386
NCT00464386
Terminated
Not Applicable

Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU)

United States Army Institute of Surgical Research1 site in 1 country23 target enrollmentSeptember 2006
ConditionsBurnsTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burns
Sponsor
United States Army Institute of Surgical Research
Enrollment
23
Locations
1
Primary Endpoint
To prospectively evaluate the reliability of continuous glucose monitors and the advisability of their use in patients with severe trauma and or thermal injury.
Status
Terminated
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
United States Army Institute of Surgical Research
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control.(90 days)

Study Sites (1)

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