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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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Microdialysis

Intervention Type PROCEDURE

Guardian RT

Intervention Type DEVICE

Glucoday S

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Thomas R Pieber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Graz, Graz, Austria

Locations

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Medical University Graz - Clinical Research Center

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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CM9 diabetes_sensor

Identifier Type: -

Identifier Source: org_study_id