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| Name | Class |
|---|---|
| Kentron | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose Monitoring | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlySure Intravascular Continuous glucose monitoring sensor | Device | Comparator device is an iSTAT device from Abbott Diagnostics |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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