Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Tamberger, M.
Open, Controlled Pilot Study of an Investigational Extended Wear Insulin Infusion Set during Home Use in People with Type 1 Diabetes Mellitus
Humanmedizin; [ Diplomarbeit ] Medizinische Universität Graz; 2023. pp.
- Autor*innen der Med Uni Graz:
- Betreuer*innen:
- Mader Julia
- Münzker Julia
- Altmetrics:
- Abstract:
- Introduction Insulin infusion sets (IIS) are commonly perceived as the Achilles heel of continuous subcutaneous insulin infusion (CSII) therapy. Since the occurrence of insulin pump failures is often a cause of insulin infusion set failures (such as kinking or blockage), manufacturers recommend a change every 72 hours for Teflon cannulas to ensure safe and effective blood glucose control. Nevertheless, many people with insulin treated diabetes use their IIS longer than recommended for economical, ecological and lifestyle reasons. The purpose of this study is to evaluate the safety and feasibility of a newly designed investigational infusion set in people with insulin treated diabetes during four extended home use periods of up to 14 days. The new investigational device is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump. Methods This study was conducted as a single-center, open, controlled, and randomized, cross-over pilot study. It served as a random sequence study of device performance, tolerability and safety of an investigational infusion set device compared to a commercially available Teflon infusion set during four home use periods of up to 14 days each (sequence: AABB vs. BBAA). The primary endpoint was evaluated by analyzing the duration (days) of successful insulin delivery through the investigational and control infusion sets wear periods, where success was defined as the days from infusion set insertion to either 1) a removal due to normal use or 2) an infusion set failure. Insulin pump and continuous glucose monitoring (CGM) data were collected periodically. Results Twelve out of 13 enrolled participants completed the study using Medtronic or Roche insulin pumps. The participants wore the investigational IIS for an average of 9.3 ± 4.3 days and the control IISs for 9.6 ± 3.2 days. Twenty-four of 27 (89%) control devices and 18 of 25 (72%) investigational devices remained in use for 7 days or longer. By day 13, 26% of control and 36% of investigational infusion sets were still operable. Discussion Interestingly, we observed unexpectedly high survival rates observed in control sets at 3 days and beyond. This study provided additional support for decisions to further refine and develop the investigational infusion set for extended wear. Our findings further reinforce the critical need for intensive site and participant training regarding how to identify set failure and indicate a clear need for revised set failure criteria more representative of participants’ opinions and needs. The main lessons learned from the study revolve around how to define and implement set failure criteria during a pivotal trial.