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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00499954
First received: July 11, 2007
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

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 Intervention
Type 1 Diabetes
 Procedure: Microdialysis
Device: Guardian RT
Device: Glucoday S

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Enrollment: 16
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499954

Locations
Austria
Medical University Graz - Clinical Research Center
Graz, Styria, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R Pieber, MD Medical University Graz, Graz, Austria
  More Information

Additional Information:
CLINICIP (background information about the overall project)  This link exits the ClinicalTrials.gov site
Healthsite (background information to the study site and investigators)  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00499954     History of Changes
Other Study ID Numbers: CM9 diabetes_sensor
Study First Received: July 11, 2007
Last Updated: July 11, 2007
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
microdialysis
subcutaneous adipose tissue
glucose sensor
glucose monitoring
 type 1 diabetes
Guardian RT
Glucoday S

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013