Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464529
Status:
COMPLETED
Last Update Posted:
2007-11-07
First Post:
2007-04-20
Brief Title:
Accuracy and Safety of Real Time Continuous Glucose Monitoring Before During and After Surgery
Sponsor:
Medical Research Foundation The Netherlands
Organization:
Medical Research Foundation The Netherlands
Study Overview
Official Title:
Peri-Operative Accuracy and Safety of Real Time Continuous Glucose Monitoring System in Cardiac Surgical Patients A Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GluContinu
Brief Summary:
The purpose of this study is to determine the safety and accuracy of the Real-Time Continuous Glucose monitoring System RT-CGMSin measuring glucose in patients scheduled for surgery before during and after surgery
Detailed Description:
RationaleStrict 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
ObjectiveTo 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 populationPatients scheduled for elective cardiac surgery InterventionAfter 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
ObjectiveTo 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 populationPatients scheduled for elective cardiac surgery InterventionAfter 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None