Amir Tirosh, Israel
Chaim Sheba Medical Center, Tel-Hashomer, and Tel-Aviv University Division of Endocrinology, Diabetes and MetabolismPresenter of 2 Presentations
FEASIBILITY CLINICAL STUDY ASSESSING THE COMPATIBILITY OF INSULIN FIASP WITH MEDTRONIC 7-DAY EXTENDED WEAR INFUSION SET
Abstract
Background and Aims
Fiasp® (Faster Insulin Aspart) is approved to be administered through a pump with an infusion set for up to 3 days, with recommendations to monitor pump settings and hypoglycemia closely. Medtronic Extended Wear Infusion Set (EWIS) is CE marked to infuse insulin Lispro and Aspart subcutaneously via Medtronic insulin pumps for up to 7 day. This feasibility study is aimed to evaluate safety and efficacy of EWIS delivery of Fiasp® for up to 7 days.
Methods
This is a single-center, prospective, open label one arm study of up to 40 subjects who use EWIS with a target for 20 subjects to complete the study. Subjects subjects used EWIS with Fiasp® Insulin with MiniMed™ 640G/670G Insulin Pumps for 4 weeks that will serve as an exploratory pilot study to assess the 7-day survival of EWIS with Fiasp® Insulin. All subjects will be instructed to change sets every 7 days or at set failure.
Results
The data collected up to date indicates that Fiasp® can be administered by EWIS for up to 7 days safely. Survival rate collected so far is with the EWIS survival rate of delivering Lispro/Aspart.
Conclusions
This is the first trial of a 7-day infusion set for Fiasp® use in insulin infusion pumps. Clinical data obtained from this prospective, single site study demonstrates that using MiniMed™ 640G/670G pumps with EWIS for subcutaneous delivery of Fiasp® for up to 7 days it both safe and efficacious.