A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring
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A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring Using the Yellow Springs Blood Glucose Analyser for Conformité Européenne (CE) Marking Purposes in a Total of Thirty Patients Admitted to The Surgical Intensive Care Unit (SICU)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results [ Time Frame: For at least 30 hours and up to 7 days ]
The study is designed to evaluate the comparative accuracy between measured blood glucose results obtained from the GlySure Continuous Glucose Monitoring System (CGM) and the YSI, and to determine if any condition or treatment affects the sensor's measured values.
Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices [ Time Frame: For at least 30 hours and up to 7 days ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient or legal representative MUST be willing to sign an informed consent document
Male and female aged 18 years and above
Require Central Venous Catheter (CVC) into the right internal Jugular vein as part of disease management and treatment
Expected to remain in the Surgical Intensive Care Unit (SICU) for at least 30 hours and up to 7 days-
Patient or legal representative unable to provide written informed consent
Patient who is pregnant
Patient who is currently being administered Mannitol
Patient with history of Pulmonary Embolism (PE)
Patient with history of thrombosis
Patient with known hyper-coagulation
Patient with known history of heparin hypersensitivity
Patient with history of heparin induced thrombocytopenia
Participation in a clinical study involving an unlicensed pharmaceutical product and/or device within the 3 months prior to enrolment in this study
Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film
Patient likely to require an MRI scan during their stay in the SICU
Patients likely to require treatment with Mannitol during time in the SICU