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临床试验/EUCTR2014-002341-22-AT
EUCTR2014-002341-22-AT进行中(未招募)不适用

Evaluation of the Effect of Glucagon Solutions on the Glucose Concentration at the Subcutaneous Administration Site in Type 1 Diabetic Patients.

Medizinische Universität Graz; Universitätsklinik für InnereMedizin; Abteilung für Endokrinologie und Stoffwechsel0 个研究点开始时间: 2014年6月11日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - 18 to 64 years of age, both inclusive
  • - Type 1 diabetes treated with CSII or MDI
  • - HbA1C < 10%
  • - BMI between 20 and 30 kg/m2
  • - Signed informed consent before any study-related activities
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 10
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • - Severe acute diseases
  • - Clinically overt diabetic complications
  • - 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 catheters as judged by the investigator
  • - Uncontrolled hypertension
  • - Use of a medication that significantly impacts glucose metabolism (e.g. oral or topical steroids) except in the case of a stable state with a minimum duration of at least three months preceding the study as well as under the condition that the state remain stable for the duration of the study
  • - No superficial veins for catheter insertion as judged by the investigator
  • - Pregnancy, breastfeeding, intention of becoming pregnant or not using adequate contraception.
  • - Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
  • - Concurrent participation in another study

研究者

发起方
Medizinische Universität Graz; Universitätsklinik für InnereMedizin; Abteilung für Endokrinologie und Stoffwechsel

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