Diabetes Mellitus type 1 MedDRA version: 16.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861
Conditions
Sponsors
Medizinische Universität Graz; Universitätsklinik für Innere Medizin; Abteilung für Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 18 to 65 years of age, both inclusive ? Type 1 diabetes treated with continuous subcutaneous insulin infusion for >12 months ? HbA1c =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: ? Severe acute diseases ? Clinically overt diabetic complications ? Mental incapacity, unwillingness, or language barriers precluding adequate understanding or co-operation ? Taking any vasoactive substances or anticoagulatory medication ? Symptomatic coronary artery disease (e.g. history of myocardial infarction, history of acute coronary syndrome, history of therapeutic coronary intervention, history of coronary bypass or stenting procedure, stable or unstable angina, positive stress test or catheterization with coronary blockages >50%), congestive heart failure, or a history of a cerebro- vascular event ? Uncontrolled hypertension ? Use of a medication that significantly impacts glucose metabolism (i.e. 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 the acting physician feels would interfere with the trial or the safety of the subject ? Blood donation within three months preceding the study ? Concurrent participation in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall goal of the study is to assess the resistance exerted by the tissue upon the insulin solution entering the tissue (hydraulic tissue resistance) at the administration site and determine its relationship to the ability of the tissue to absorb the administered insulin;Secondary Objective: Not applicable;Primary end point(s): GLUAOGTT, average plasma glucose concentration;Timepoint(s) of evaluation of this end point: during a 75g oral glucose tolerance test (OGTT) per visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: before/during the OGTT bper visit;Secondary end point(s): TR, hydraulic tissue resistance GLUmax, maximum plasma glucose concentration GLUEXmax, maximum plasma glucose excursion AUCGLU, area under the plasma glucose concentration curve INSmax, maximum plasma concentration of rapid-acting insulin AUCINS, area under the plasma insulin concentration curve TGLUmax, time to reach the maximum plasma glucose concentration TINSmax, time to reach the maximum plasma insulin concentration | — |
Countries
Austria
Contacts
Public ContactZentrum f. Med. Grundlagenforschung
Medizinische Universität Graz; Universitätsklinik für Innere Medizin; Abteilung für Endokrinologie und Stoffwechsel
Outcome results
None listed