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

Peri-Operative Accuracy and Safety of Real Time Continuous Glucose Monitoring System in Cardiac Surgical Patients. A Pilot Study

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.

Study Overview

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

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zwolle, Netherlands, 8000 GM
        • Isala Clinics, Weezenlanden location

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Henk J Bilo, MD PhD, FRCP, Isala Clinics, Diabetes Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 20, 2007

First Submitted That Met QC Criteria

April 20, 2007

First Posted (Estimate)

April 23, 2007

Study Record Updates

Last Update Posted (Estimate)

November 7, 2007

Last Update Submitted That Met QC Criteria

November 6, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06.0741

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glucose Metabolism Disorders

Clinical Trials on Real-Time Continuous Glucose monitoring System (RT-CGMS)

3
Subscribe