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Accuracy and Safety of Real Time Continuous Glucose Monitoring Before, During and After Surgery (GluContinu)

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ClinicalTrials.gov Identifier: NCT00464529
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : November 7, 2007
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medical Research Foundation, The Netherlands

Brief Summary:
The purpose of this study is to determine the safety and accuracy of the Real-Time Continuous Glucose monitoring System (RT-CGMS)in measuring glucose in patients scheduled for surgery; before, during and after surgery.

Condition or disease Intervention/treatment
Glucose Metabolism Disorders Perioperative Care Device: Real-Time Continuous Glucose monitoring System (RT-CGMS)

Detailed Description:

Rationale:Strict glycaemic control improves outcome of critically ill patients. Real Time Continuous Glucose monitoring System (RT-CGMS) is a novel system which can provide health care professionals with real time information about the blood glucose level without the need for multiple invasive measurements. Furthermore, with continuous monitoring it is possible to identify trends in glycaemic profiles. Its accuracy and safety have never been tested in a population of patients admitted to an intensive care unit.

Objective:To investigate the accuracy and safety of the RT-CGMS in patients scheduled for elective cardiac surgery. Our secondary objective is to define the possible factors interfering with reliable and adequate glucose measurements and to investigate the effect of RT-CGMS on glucose control.

Study design: Open label, randomised controlled trial. Study population:Patients scheduled for elective cardiac surgery. Intervention:After informed consent and randomisation, all patients will have the RT-CGMS inserted pre-operatively. In one group (Control group; 15 subjects), the RT-CGMS will be blinded, so that no information on blood glucose values measured and stored by the RT-CGMS will be available to care-givers, investigators or patients during the study period. In the other group (Active group, 15 subjects), the RT-CGMS will not be blinded. The system will alert whenever a glucose level falls below or rises above preset values. Sensor values are not intended to be used directly for making therapy adjustments. Whenever a value is below or above the preset value, the blood glucose level will be measured using separate blood analysis and therapy adjustments based on this value will be done according to the (ICU) protocol.

Study endpoints: Correlation between data obtained with the RT-CGMS and the conventional method. Degree of glucose control defined as the time spent in normoglycaemia, hypoglycaemia and hyperglycaemia, as recorded both with sensor measurements and ward measurements. Occurrence of significant clinical events and its effect on RT-CGMS.


Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Peri-Operative Accuracy and Safety of Real Time Continuous Glucose Monitoring System in Cardiac Surgical Patients. A Pilot Study
Study Start Date : May 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources





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
Criteria

Inclusion Criteria:

  • Patients scheduled for elective cardiac surgery
  • Age >18 years
  • Both patients with diabetes mellitus as non-diabetic patients are eligible

Exclusion Criteria:

  • Failure to obtain informed consent
  • pre-admission insulin treatment for diabetes mellitus

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): NCT00464529


Locations
Netherlands
Isala Clinics, Weezenlanden location
Zwolle, Netherlands, 8000 GM
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Medtronic
Investigators
Principal Investigator: Henk J Bilo, MD PhD, FRCP Isala Clinics, Diabetes Centre

ClinicalTrials.gov Identifier: NCT00464529     History of Changes
Other Study ID Numbers: 06.0741
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: November 7, 2007
Last Verified: May 2007

Keywords provided by Medical Research Foundation, The Netherlands:
blood glucose
hyperglycemia
hypoglycemia
Perioperative care
inpatient

Additional relevant MeSH terms:
Metabolic Diseases
Glucose Metabolism Disorders