Blood Glucose Monitoring in Medical ICU Clinical Trial
— MICUOfficial 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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| GlySure | Kentron |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety in Use | No Serious Adverse Events causally related to the device | During ICU Stay, normally less than 7 days | Yes |
| Primary | 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 | No |