Continuous Glucose Monitoring (POC) in the ICU

Not Applicable

Terminated

• Conditions: Trauma; Burns
• Interventions: Device: Continuous Glucose Monitoring

• Registration Number: NCT00464386
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-04-20
• Study First Submitted QC: 2007-04-20
• Study First Posted: 2007-04-23
• Primary Completion: 2009-02
• Study Completion: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitoring	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control.	90 days

Trial Locations

Locations (1)

US Army Institute of Surgical Research; 🇺🇸 Fort Sam Houston, Texas, United States