Continuous Glucose Monitoring (POC) in the ICU

NCT00464386 | Terminated

• 1 other identifier: H-06-011
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Trauma

Keywords

Severe burns; Severe Trauma; Closed loop insulin; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  90 days

Study Arms (2)

POC Glucose Testing

NO INTERVENTION

Hourly blood glucose monitoring with point of care glucometer (i.e., current standard of care).

Continuous Glucose Monitoring

EXPERIMENTAL

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

Interventions

Continuous Glucose Monitoring DEVICE

measure glucose levels on burn patients

Also known as: Guardian continuous glucose monitor

Continuous Glucose Monitoring

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• remain 1 week in an ICU
• years old
• severe trauma or thermal injury greater than 20% TBSA burn

You may not qualify if:

• cerebral arterial injury
• myocardial infarction
• pre-existing renal failure or liver failure
• history of hypoglycemia
• history or high risk of seizures
• pregnancy

Sponsors & Collaborators

• United States Army Institute of Surgical Research: lead

Study Sites (1)

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

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

  PMID: 11594298 BACKGROUND

MeSH Terms

Conditions

Burns; Wounds and Injuries

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Heather Pidcoke, MD

  US Army Institute of Surgical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: September 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: December 1, 2013
• Last Updated: May 2, 2016

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)