NCT02142088

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: GlySure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Blood Glucose Monitoring in Medical ICU

Interventions

Type	Name	Description
DEVICE	GlySure Intravascular Continuous glucose monitoring sensor	Comparator device is an iSTAT device from Abbott Diagnostics

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-05-20
• Last updated: 2014-05-20