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

NCT00499954 | Completed

• 1 other identifier: CM9 diabetes_sensor
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

microdialysis; subcutaneous adipose tissue; glucose sensor; glucose monitoring; type 1 diabetes; Guardian RT; Glucoday S

Interventions

Microdialysis PROCEDURE

Guardian RT DEVICE

Glucoday S DEVICE

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz - Clinical Research Center

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Microdialysis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dialysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thomas R Pieber, MD

  Medical University Graz, Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2007
• First Posted: July 12, 2007
• Study Start: February 1, 2006
• Last Updated: July 12, 2007

Record last verified: 2006-04

Locations

AU (1)