NCT01709851

Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes

A Single-center, Open, Pilot Trial to Investigate the Performance of the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Over the last years, a number of systems for continuous subcutaneous glucose monitoring have been marketed and are routinely used in patients with diabetes to obtain more detailed information about 24-hour glucose profiles. In the hospital, numerous factors influencing glycemic control and possibly leading to glucose excursions out of the desired range exist, e.g. interventions for which the patient has to remain fasting or medications such as corticosteroids or vasopressors. A reliable continuous glucose signal could help to observe levels of glycaemia not only at defined time-points but continuously, making it possible for physicians and nursing staff to better adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo- or hyperglycaemia. In the hospital setting, vascular access is granted in the majority of patients and could as well be used as an alternative site for continuous glucose monitoring. The aim of the present study is to assess accuracy of the glucose data obtained by means of an intravascular microdialysis-based CGM system against venous blood glucose reference measurements.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Vascular microdialysis using the GMD-system	Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system
DEVICE	Vascular and subcutaneous microdialysis using the GMD-system	Glucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-12-01
• Completion: 2013-04-01
• First posted: 2012-10-18
• Last updated: 2013-04-16

Locations

1 site across 1 country: Austria