Blood Glucose Monitoring in Medical ICU Clinical Trial
Official title:
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic