Type 1 diabetes
Conditions
Interventions
Group 1: Single-arm
Medical Device Study: Investigational medical device - Omnipod DASH Insulin Management System (Insulet Corp., Acton, MA, USA)
This is an open-label, single-center, single-arm, pro
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age at the time of signing the consent form between 18 to 64 years (both inclusive) 2. Diagnosed with type 1 diabetes mellitus (T1D) 3. Being on insulin pump therapy for more than 3 months prior to screening 4. Glycosylated haemoglobin type A1c (HbA1c) levels = 8.5% (= 69 mmol/mol) at screening. 5. Random C-peptide levels = 0.03 nmol/L (= 0.09 ng/mL) 6. Signed informed consent prior to the participation in any study-related activities.
Exclusion criteria
Exclusion criteria: 1. Severe acute and/or chronic diseases which based on the investigator’s judgment would interfere with the trial or the safety of the subject 2. Clinically overt diabetic complications 3. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation 4. Uncontrolled hypertension, as judged by investigator 5. Diseases of the skin which could interfere with the insulin infusion cannula and glucose sensor application as judged by the investigator 6. Use of a medication that significantly impacts glucose metabolism (e.g.: corticosteroids with systemic effect, beta-2-sympathomimetics) 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 status remains stable for the duration of the study 7. Current total daily insulin dose exceeding 60 insulin units 8. Pregnancy, breastfeeding, intention of becoming pregnant, or not using adequate contraception 9. Presence of needle phobia 10. Not willing to avoid steam baths, sauna, swimming and other strenuous activities between Visit 2 and Visit 8 of the study to ensure safe wearing of the patch pumps and sensors 11. Known allergy/hypersensitivity to any of the materials/supplies used during the study 12. Severe hypoglycemia or ketoacidosis requiring hospitalization or emergency room visit in the 3 months prior to screening 13. Significant medical history of alcoholism or drug abuse that in the opinion of the investigator would compromise the subject’s safety or results of the study 14. Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 30 days before signing of consent in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TFR, tissue flow resistance determined on each day of infusion site use | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pmax, maximum pressure observed during bolus delivery into tissue 2. Pmean, mean pressure observed during bolus delivery into tissue 3. PSmax, maximum pressure observed during bolus delivery into air 4. PSmean, mean pressure observed during bolus delivery into air 5. RS, flow resistance associated with the connecting tubing only 6. TTRGDay, proportion of time that the glucose level is in the target range of 3.9–10.0 mmol/L 7. GMeanDay, mean glucose level observed during a study day 8. CDay, amount of carbohydrates ingested during a study day 9. TDI, total daily insulin dose administered during a study day 10. BIDay, amount of insulin given as a bolus during a study day 11. BICRDay, ratio between delivered bolus insulin and ingested carbohydrates calculated for a study day | — |
Countries
Austria
Contacts
Public ContactEva Svehlikova
Medizinische Universität Graz
Outcome results
None listed