Diabetes Mellitus type 1 MedDRA version: 21.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861
Conditions
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 to 64 years of age, both inclusive - Type 1 diabetes treated with CSII - Fasting C-peptide =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Severe acute and/or chronic 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 - Uncontrolled hypertension - Diseases of the skin which could interfere with the catheter and sensor application as judged by the investigator - No superficial veins for catheter insertion 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 - Current enrollment or past participation in another investigational study ore signing of consent in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the strength of the relationship between the extent of insulin absorption and tissue flow resistance (i.e., the resistance exerted by the tissue on the infused insulin solution) during prolonged use of an insulin infusion site. ;Secondary Objective: To determine the histologic correlate of the increased tissue flow resistance in the tissue surrounding an insulin infusion cannula. & To ascertain the cause of the reduction in the extent of insulin absorption after prolonged infusion site use. ;Primary end point(s): AUCinsulin, area under the plasma insulin concentration curve ;Timepoint(s) of evaluation of this end point: during a 75g oral glucose tolerance test (OGTT) per visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - TFR, tissue flow resistance determined on each day during infusion site usage - TINSmax, time to reach the maximum plasma insulin concentration during the 5-h OGTTs - GLUmean3-5h, average plasma glucose concentration during the last 2 hours of the 5-h OGTTs - AUCglucose, area under the plasma glucose concentration curve observed during the 5-h OGTTs - TGLUmax, time to reach the maximum plasma glucose concentration during the 5-h OGTTs - CLL, number of cells per tissue section - CollF, number of collagen fibrils per tissue section - InsF, number of insulin fibrils per tissue section - number of iproteolytic enzymes (like insulin degrading enzymes) per tissue section ;Timepoint(s) of evaluation of this end point: before/during the OGTT per visit | — |
Countries
Austria
Contacts
Public ContactZentrum für Medizinische Forschung
Medizinische Universität Graz
Outcome results
None listed