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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499954
• Other study ID #: CM9 diabetes_sensor
• Status: Completed
• Phase: N/A
• First received: July 11, 2007
• Last updated: July 11, 2007
• Start date: February 2006

Study information

• Verified date: April 2006
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Procedure:
• Microdialysis

Device:
• Guardian RT

• Glucoday S

Locations

Country	Name	City	State
Austria	Medical University Graz - Clinical Research Center	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria,