Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00464529
Study type Observational
Source Medical Research Foundation, The Netherlands
Contact
Status Completed
Phase N/A
Start date May 2007
Completion date October 2007

See also
  Status Clinical Trial Phase
Recruiting NCT05081037 - Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS) N/A
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Active, not recruiting NCT05505994 - The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin Phase 3
Completed NCT03623113 - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes N/A
Completed NCT03623139 - Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes N/A
Completed NCT03359629 - Spectrophon LTD Glucometry Monitor Accuracy
Recruiting NCT03682640 - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes Phase 2
Completed NCT02697305 - Incretin Effects of Branched Chain Amino Acids N/A
Completed NCT01737164 - Effect of Age on Glucose and Lipid Metabolism N/A
Terminated NCT00935766 - Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries Phase 3
Recruiting NCT03613688 - Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control N/A
Completed NCT04098549 - The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes N/A
Terminated NCT04031404 - Glucose and Non-Invasive Brain Stimulation N/A
Active, not recruiting NCT03577964 - Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
Active, not recruiting NCT03232008 - Canderel:Effects on Blood Glucose Concentration and Appetite Scores N/A
Completed NCT04042142 - Glucagon Resistance in Patients With NAFLD N/A
Active, not recruiting NCT05607745 - Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study N/A
Completed NCT04004273 - Diabetes, Exercise and Liver Fat (DELIVER) N/A
Completed NCT04082923 - Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery N/A