Continuous Glucose Monitoring (POC) in the ICU

Trauma Clinical Trial

— POC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00464386
• Other study ID #: H-06-011
• Status: Terminated
• Phase: N/A
• First received: April 20, 2007
• Last updated: April 28, 2016
• Start date: September 2006
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 2013
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Trauma

Intervention

Device:
• Continuous Glucose Monitoring
measure glucose levels on burn patients

Locations

Country	Name	City	State
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kerr D. Continuous blood glucose monitoring: detection and prevention of hypoglycaemia. Int J Clin Pract Suppl. 2001 Sep;(123):43-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control.		90 days