- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00464529
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zwolle, Netherlands, 8000 GM
- Isala Clinics, Weezenlanden location
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Henk J Bilo, MD PhD, FRCP, Isala Clinics, Diabetes Centre
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
-
University of AberdeenCompletedMetabolism Disorder, GlucoseUnited Kingdom
-
Columbia UniversityCompletedMetabolism Disorder, GlucoseUnited States
-
University of LeipzigInstitut für Gesundheits- und Praxismanagement GmbHWithdrawn
-
Purdue UniversityAlmond Board of CaliforniaActive, not recruitingGlucose Intolerance | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
University of Missouri-ColumbiaCompletedGlucose | Blood Sugar; High | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
University of South CarolinaCompletedPhysical Activity | Sedentary Lifestyle | Metabolism Disorder, GlucoseUnited States
-
Solvay PharmaceuticalsTerminatedDyslipidemia | Glucose Metabolism DisorderPoland, Croatia, Finland, France, Germany, Netherlands, Romania, Ukraine
-
DLR German Aerospace CenterCompletedGlucose Metabolism Disorders | Local Glucose Uptake
-
Solvay PharmaceuticalsCompletedDyslipidemia/Glucose Metabolism DisorderPoland, Ukraine, United Kingdom
-
Solvay PharmaceuticalsCompletedDyslipidemia/Glucose Metabolism DisorderCzech Republic, France, Hungary, India, Lithuania, Poland, Slovakia
Clinical Trials on Real-Time Continuous Glucose monitoring System (RT-CGMS)
-
West China HospitalCompletedFeasibility | Safety | Continuous Glucose Monitoring System | AccuracyChina
-
Medical Research Foundation, The NetherlandsCompletedDiabetes Mellitus, Type 1Netherlands
-
Peking University Third HospitalBeijing Municipal Health CommissionRecruitingPregnancy Related | Pregnancy Outcome | Time in Range | Type2diabetes | Continuous Glucose MonitoringChina
-
University Hospital, ToursCompleted
-
Sheba Medical CenterUnknownDiabetes MellitusIsrael
-
Charles University, Czech RepublicUnknown
-
University of Maryland, BaltimoreUniversity of Maryland, Baltimore County; Baltimore Veterans Affairs Medical...RecruitingDepression | PreDiabetes | Aging | Cognitive Decline | Functional Status | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
Charles University, Czech RepublicUnknownDiabetes Mellitus, Type 1Czechia
-
Manchester University NHS Foundation TrustDexCom, Inc.CompletedDiabetes Mellitus, Type 1United Kingdom
-
Norwegian University of Science and TechnologyNorwegian Diabetes AssociationCompletedDiabetes Mellitus, Type 1Norway