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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This study has been withdrawn prior to enrollment.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:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Robert Schonberger, Yale University
ClinicalTrials.gov Identifier:
NCT01394588
First received: July 12, 2011
Last updated: May 2, 2014
Last verified: May 2014
  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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394588

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

No publications provided

Responsible Party: Robert Schonberger, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01394588     History of Changes
Other Study ID Numbers: 1006006996
Study First Received: July 12, 2011
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Cardiac Surgery
Perioperative Glucose Control

ClinicalTrials.gov processed this record on November 27, 2014