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Trial record 95 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00499954
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : July 12, 2007
Information provided by:
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Procedure: Microdialysis Device: Guardian RT Device: Glucoday S

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Study Type : Observational
Actual Enrollment : 16 participants
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
Study Start Date : February 2006

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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00499954

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

Additional Information:
Layout table for additonal information Identifier: NCT00499954     History of Changes
Other Study ID Numbers: CM9 diabetes_sensor
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: July 12, 2007
Last Verified: April 2006

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

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