Continuous Glucose Monitoring (POC) in the ICU | NCT00464386

Studies
Continuous Glucose Monitoring (POC) in the ICU

NCT00464386

Sponsor

United States Army Institute of Surgical Research

Status

Terminated

Last Update Posted

May 2, 2016Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Burns
Trauma

Interventions

Continuous Glucose Monitoring

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study device required infeasible modifications. No patients received device.

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Feb 2009Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 20, 2007

First Submission Date that Met QC Criteria

Apr 20, 2007

First Posted Date

Apr 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2016

Last Update Posted Date

May 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Continuous Glucose Monitoring	Device	measure glucose levels on burn patients	Continuous Glucose Monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control.		90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heather Pidcoke, MD	US Army Institute of Surgical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
US Army Institute of Surgical Research		Fort Sam Houston	Texas	78234	United States

References Module

Citations

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

Type	Date	Date Unknown
Release	Dec 27, 2016
Reset	Feb 17, 2017
Release	Oct 26, 2017
Reset	Dec 1, 2017

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 27, 2016			Feb 17, 2017
Oct 26, 2017

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

ID	Term
D002056	Burns
D014947	Wounds and Injuries