Continuous Glucose Monitoring (POC) in the ICU

NCT ID: NCT00464386

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Burns Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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POC Glucose Testing

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type DEVICE

measure glucose levels on burn patients

Interventions

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Continuous Glucose Monitoring

measure glucose levels on burn patients

Intervention Type DEVICE

Other Intervention Names

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Guardian continuous glucose monitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Army Institute of Surgical Research

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Pidcoke, MD

Role: PRINCIPAL_INVESTIGATOR

US Army Institute of Surgical Research

Locations

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US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 11594298 (View on PubMed)

Other Identifiers

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H-06-011

Identifier Type: -

Identifier Source: org_study_id

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