Comparative Study of GlySure Continuous Intra-vascular Glucose Monitoring and Intermittent Monitoring in Medical ICU (MICU)

A Clinical Study to Evaluate the Safety of the GlySure Continuous Intra-vascular Glucose Monitoring System, and Its Performance in Comparison to Intermittent Blood Glucose Monitoring in Adult Intensive Care Unit Patients

It has been shown that close control of blood glucose levels in the intensive care unit patient has benefits for patient morbidity and mortality rates as well as an impact upon discharge times. GlySure has previously completed an evaluation of its intra-vascular glucose monitoring system in patients in a surgical ICU environment after cardiac surgery. This study seeks to evaluate the same equipment being used in a wider range of patients with a range of underlying conditions who require treatment in medical ICU's. The GlySure device consists of a sensor that is placed into the patient's blood through a central venous catheter. It measures blood glucose levels continuously which allows for more rapid control of blood glucose levels to be achieved as compared to existing methods where blood samples are taken repeatedly every 15 minutes or so.

The study is designed to show that the sensor can be used for a protracted period of time, giving accurate results when compared to a reference technique using the i-STAT device. The investigators intend to show that the device performs safely for the required time within the ICU.

Study Overview

• Status: Unknown
• Conditions: Blood Glucose Monitoring in Medical ICU
• Intervention / Treatment: Device: GlySure Intravascular Continuous glucose monitoring sensor

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient or legal representative MUST be willing to sign an informed consent document
2. Patient is male or female aged 18 years or above
3. Patient requires a CVC to be inserted as part of disease management and treatment
4. Patient is expected to remain in the intensive care unit for at least 36 hours post enrolment to the study

Exclusion Criteria:

1. Patient or legal representative is unable to provide written informed consent
2. Patient who is pregnant
3. Patient who is currently being administered Mannitol and/or may require the administration of Mannitol whilst in the ICU
4. Patient with history of pulmonary embolism (PE)
5. Patient with history of thrombosis
6. Patient with known hyper-coagulation
7. Patient with known history of heparin hypersensitivity
8. Patient with history of heparin induced thrombocytopenia
9. Participation in a clinical study involving an unlicensed pharmaceutical product or device within the 3 months prior to enrolment in this study
10. Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film or StatLock® devices

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Glucose Monitoring; Each patient will undergo simultaneous Glucose monitoring with 2 devices. One is GlySure's intervascular continuous measurement sensor (test device) introduced through a CVC, and the other measures glucose intermittently from repeated venous blood samples drawn through an indwelling ventflon style catheter	Device: GlySure Intravascular Continuous glucose monitoring sensor; Comparator device is an iSTAT device from Abbott Diagnostics; Other Names: Devices not yet issued for study, so serial numbers not yet linked to study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety in Use	No Serious Adverse Events causally related to the device	During ICU Stay, normally less than 7 days
MARD Score	Average aggregate MARD to be below 10%, 95% of subjects to have a MARD of less than 25%	During ICU stay, normally less than 7 days

Collaborators and Investigators

• Sponsor: GlySure
• Collaborators: Kentron

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 20, 2014

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Glycaemic Control; Glucose Monitoring; Intravascular Glucose Monitoring
• Other Study ID Numbers: 2014.01.CE