Glucose Metabolism Disorders Clinical Trial
Official title:
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.
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.
;
Time Perspective: Prospective
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