Investigation of Correlation Between Concentrations of Glucose in Blood and Interstitial Fluid in Type 1 Diabetics
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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.
Condition or disease
Type 1 Diabetes
Procedure: MicrodialysisDevice: Guardian RTDevice: Glucoday S
An Open, Mono-Centre Trial to Investigate the Correlation Between Concentrations of Glucose in Arterialized Venous Blood and Subcutaneous Interstitial Fluid Applying Different Extracorporeal Sensor Techniques in Type 1 Diabetics
Study Start Date :
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Ages Eligible for Study:
19 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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