Diabetes Mellitus type 1 MedDRA version: 18.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861
Conditions
Sponsors
Medizinische Universität Graz; Universitätsklinik fürInnere Medizin; Abteilung für Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Type 1 diabetes treated with with continuous subcutaneous insulin infusion - 18 to 64 years of age, both inclusive - HbA1C =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Severe acute diseases which the investigator or the acting physician feels would interfere with the trial or the safety of the subject - Clinically overt diabetic complications - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or co-operation - Taking any vasoactive substances or anticoagulatory medication Uncontrolled hypertension - Diseases of the skin which could interfere with the sensor and the catheter application as judged by the investigator - 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 - 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 aim of this study is to monitor the hydraulic tissue resistance at the subcutaneous tissue sites of infusion of an insulin and insulin-free solution in patients with type 1 diabetes and to determine the frequency distributions of the hydraulic tissue resistance at theses infusion sites over a time period of 7 days.;Secondary Objective: Not applicable;Primary end point(s): sTR, specific tissue resistance ;Timepoint(s) of evaluation of this end point: on each day during the infusion sites usage period of 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - TR, tissue resistance - ?PTmean, mean pressure increase generated by the tissue during bolus delivery - ?PSmean, mean pressure increase generated by the system during bolus delivery -Pmean, mean pressure observed during bolus delivery - Rsys, hydraulic resistance exerted by the infusion line only ;Timepoint(s) of evaluation of this end point: on each day during the infusion sites usage period of 7 days | — |
Countries
Austria
Contacts
Public ContactZentrum f. Med. Grundlagenforschung
Medizinische Universität Graz; Universitätsklinik für InnereMedizin; Abteilung für Endokrinologie und Stoffwechsel
Outcome results
None listed