A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the system performance of the GlySure Continuous Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.

Official Title
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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)

Conditions
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Continuous Glucose Measurement

Intervention / Treatment
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* Device: Continuous Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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- Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring System<br> | Device: Continuous Glucose Monitoring System<br> <br> * Other names: Glysure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results | 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. | For at least 30 hours and up to 7 days | 
| Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices |  | For at least 30 hours and up to 7 days |