Investigation of Correlation Between Concentrations of Glucose in Blood and Interstitial Fluid in Type 1 Diabetics

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT00499954
• Lead Sponsor: Medical University of Graz

Brief Summary

This is a mono-centre trial performed at the Center for Clinical Research at the Medical University Graz. There will be a screening information and a study visit.In the study visit arterialized venous blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (ISF) with microdialysis for glucose determination will be performed. Additionally to the laboratory analysis of the subcutaneous glucose samples, the glucose will be measured with extracorporeal on-line sensors and two marketed devices (Guardian RT and Glucoday S).The study visit will last 30 hours starting with the insertion of microdialysis catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the Glucoday S system and Guardian RT system. The primary hypothesis of the study is: Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood glucose concentration profile in type 1 diabetic subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Status Verified: 2006-04
• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-11
• Last Update Submitted: 2007-07-11
• Study First Posted: 2007-07-12
• Last Update Posted: 2007-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Signed informed consent obtained before any trial-related activities.
• Skin fold thickness of minimally 5 mm
• Age of patients in the range from 19 to 60 years.
• Type 1 diabetes

Exclusion Criteria

• Severe acute and/or chronic diseases
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
• Taking of any vasoactive substances or anticoagulation medication.
• Diseases of the skin which could interfere with application of the catheters
• Pregnancy or breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Medical University Graz - Clinical Research Center; 🇦🇹 Graz, Styria, Austria