Continuous Glucose Monitoring (POC) in the ICU

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burns, Trauma

Intervention / Treatment
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* Device: Continuous Glucose Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: POC Glucose Testing<br>Hourly blood glucose monitoring with point of care glucometer (i.e., current standard of care). | |
| Experimental: Continuous Glucose Monitoring<br>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<br>* measure glucose levels on burn patients<br>* Other names: Guardian continuous glucose monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control. |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe burns, Severe Trauma, Closed loop insulin, continuous glucose monitoring