Continuous Glucose Monitoring (POC) in the ICU - Full Text View

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00464386

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: Point of Care Glucometer monitor

MedlinePlus related topics: Burns Injuries Wounds

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU)

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 ]

Estimated Enrollment:	84
Study Start Date:	September 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
glucose monitoring: No Intervention	Device: Point of Care Glucometer monitor measure glucose levels on burn patients

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464386

Contacts

Contact: Chaya Galin, RN	210-916-7154	chaya.galin@amedd.army.mil
Contact: Michelle Morrow, RN	210-916-8147	michelle.morrow@amedd.army.mil

Locations

United States, Texas
US Army Institute of Surgical Research	Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Annette R. McClinton, RN, MA 210-916-2834 annette.mcclinton@amedd.army.mil
Contact: Lynn Platteborze, BS, MS 210-916-9351 lynn.platteborze@amedd.army.mil
Principal Investigator: Heather Pidcoke, MD

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:

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

Responsible Party:	US Army Institute of Surgical Research ( Heather Pidcoke, MD )
Study ID Numbers:	H-06-011
Study First Received:	April 20, 2007
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00464386
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

Study placed in the following topic categories:

Burns
Wounds and Injuries
Insulin

ClinicalTrials.gov processed this record on January 16, 2009