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TerminatedNCT00464386POCUpdated May 2, 2016

Continuous Glucose Monitoring (POC) in the ICU

An interventional study of Continuous Glucose Monitoring in Burns and Trauma, sponsored by United States Army Institute of Surgical Research. Terminated at 1 site in United States. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by United States Army Institute of Surgical Research · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Study device required infeasible modifications. No patients received device.
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 72 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Burns
  • Trauma

Keywords

  • Severe burns
  • Severe Trauma
  • Closed loop insulin
  • continuous glucose monitoring
03

In context

Lead sponsor

United States Army Institute of Surgical Research is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • remain 1 week in an ICU
  • 18-72 years old
  • severe trauma or thermal injury greater than 20% TBSA burn

Exclusion criteria

Exclusion Criteria:

  • cerebral arterial injury
  • myocardial infarction
  • pre-existing renal failure or liver failure
  • history of hypoglycemia
  • history or high risk of seizures
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • No intervention
    POC Glucose Testing

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

  • Experimental
    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).

    Device: Continuous Glucose Monitoring

Interventions

  • DeviceContinuous Glucose Monitoring

    measure glucose levels on burn patients

    Also known as: Guardian continuous glucose monitor

06

What researchers measure

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.

    Time frame: 90 days

Secondary outcomes

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

    Time frame: 90 days

07

Study locations

1 site
  • US Army Institute of Surgical Research
    Fort Sam Houston, Texas 78234, United States
08

References and documents

Publications

  • Kerr D. Continuous blood glucose monitoring: detection and prevention of hypoglycaemia. Int J Clin Pract Suppl. 2001 Sep;(123):43-6. PubMed 11594298 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00464386
Lead sponsor
United States Army Institute of Surgical Research
Responsible party
Sponsor
First posted
Apr 23, 2007
Start date
Sep 2006
Primary completion
Feb 2009
Completion
Dec 2013
Last update
May 2, 2016

Study contacts

Heather Pidcoke, MD
principal investigator · US Army Institute of Surgical Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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