NCT02421107

GlySure Acute Care Settings Study

A Clinical Study to Evaluate the Safety of the GlySure Continuous Intravascular 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: 40 (estimated)
• Sponsor: GlySure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The company who have developed the GlySure product have previously carried out a study to be able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels. This was done with patients in the intensive care unit (ICU) after heart surgery. The company now want to confirm that the GlySure product is accurate at measuring blood glucose levels on all patients who stay in the ICU. This clinical study requires 40 patients and is to check the safety of a continuous Glucose Monitoring System (GlySure) and it's performance in comparison to separate individual blood glucose testing using a hand held blood tester called i-STAT. Each patient must be in the study for at least 36 hours. The main benefit of continuous blood glucose monitoring is that it gives a true picture of the glucose status of a patient and this can potentially help avoid the glucose level dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can intervene based on 'real-time' data on the glucose levels. In this study patient treatment is not dictated by the data measured during the study. Clinicians are blind to the results on the GlySure monitor.

Conditions

• Adult Intensive Care Patients

Interventions

Type	Name	Description
OTHER	Glysure CGM
OTHER	iStat intermittent testing

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-04-20
• Last updated: 2015-04-20