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临床试验/NCT00499954
NCT00499954已完成不适用

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

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Other

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Medical University of Graz
申办方类型
Other

研究点 (1)

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