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Continuous Glucose Monitoring Technology in the Perioperative Period During Cardiac Surgery

This study has been withdrawn prior to enrollment.
(On further investigation, it was found that the continuous glucose monitors required a calibration period that precluded reliable data collection.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394588
First Posted: July 14, 2011
Last Update Posted: May 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Robert Schonberger, Yale University
  Purpose
This is an observational study of continuous glucose monitoring technology during cardiac surgery. The investigators would like to develop data for descriptive analysis of a comparison of continuous glucose monitoring with a gold standard under the conditions of cardiac surgery.

Condition Intervention
Cardiac Surgery Device: Use of continuous glucose monitor during surgery. ( Medtronic Minimed Guardian REALTime Continuous Glucose Monitor)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Trial of Continuous Glucose Monitoring Technology in the Perioperative Period During Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Robert Schonberger, Yale University:

Enrollment: 0
Study Start Date: August 2010
Groups/Cohorts Assigned Interventions
Cardiac Surgery Patients
Competent Adult Patients going for elective cardiac surgery.
Device: Use of continuous glucose monitor during surgery. ( Medtronic Minimed Guardian REALTime Continuous Glucose Monitor)
Use of continuous glucose monitor during surgery.
Other Name: Medtronic Minimed Guardian REALTime Continuous Glucose Monitor

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Competent adults scheduled for elective cardiac surgery.
Criteria

Inclusion Criteria:

  • Competent adults scheduled for elective cardiac surgery.

Exclusion Criteria:

  • Inability to consent, emergency surgery.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394588


Sponsors and Collaborators
Yale University
Medtronic
Investigators
Principal Investigator: Robert Schonberger, MD Yale University
  More Information

Responsible Party: Robert Schonberger, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01394588     History of Changes
Other Study ID Numbers: 1006006996
First Submitted: July 12, 2011
First Posted: July 14, 2011
Last Update Posted: May 5, 2014
Last Verified: May 2014

Keywords provided by Robert Schonberger, Yale University:
Cardiac Surgery
Perioperative Glucose Control


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