NCT01580176

Continuous GlucoseMonitor for Measurement of Blood Glucose Level

A Prospective Clinical Trial on Agreement to Evaluate the GlucoseMonitor, a Novel Device for Continuous Assessment of Blood Glucose Levels, in Comparison With the RAPIDLab® 1265 Blood Gas Analyser (ContAssGlu)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Susanne Frankenhauser · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will be the first study in which the new central venous microdialysis-based continuous glucose monitoring system (Continuous GlucoseMonitor) is used to investigate the performance of this Continuous GlucoseMonitor, as the measurements will be compared with a point of care reference (RAPIDLab® 1265 blood gas analyser). Further important points are also much less blood samplings / blood loss for the patient and personnel costs.

Detailed description

The current standard for measuring blood glucose concentrations on ICU is to manually draw a blood sample from an arterial catheter and analyse the sample using a point of care blood gas analyser. This technique has several disadvantages as causes considerable blood loss and does not produce a continuous blood glucose profile and it is labour intensive (multiple samples over time are needed to follow the changes in blood glucose concentration). The monitoring system (Continuous GlucoseMonitor) based on the microdialysis technique has the advantage that not blood, but a physiological fluid such as saline is used as test medium. In brief, a physiological fluid, called the perfusate is continuously perfused through the microdialysis probe. At the membrane of the probe, glucose (as other low-molecular weight molecules) diffuses from the surrounding sample into the perfusate, now called dialysate, and is transported outside the probe for ex vivo monitoring.

Conditions

• Other Surgical Procedures

Interventions

Type	Name	Description
DEVICE	continuous GlucoseMonitor	The blood glucose and blood lactate levels will be taken continuously by the Continuous GlucoseMonitor and will be recorded twelve times.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2012-04-18
• Last updated: 2013-12-20

Locations

1 site across 1 country: Germany