910-P: Real-World Clinical Data on the Extended Infusion Set

Abstract

Objective: The Medtronic Extended infusion set (EIS) is the first and only infusion set approved for up to 7-day use. Prior studies established clinical safety and efficacy of the EIS. The purpose of this retrospective analysis was to assess real-world data on the EIS performance and user behaviors associated with the EIS including wear duration and asynchronous reservoir changes. Methods: A limited launch of the EIS outside the US (OUS) included MiniMed™ 640G/670G/780G users. Due to regional legal requirements, aggregated pump data from EIS users were not separated from other user data. To identify EIS users, an algorithm was developed based on the expected behavior patterns associated with an infusion set change, e.g., tubing fills. From the same cohort, individuals using the EIS (n=108) versus regular 3-day sets (n=414) were identified by a mean or median time between substantial tubing fills. To assess synchronous and asynchronous set/reservoir changes, reservoir changes were determined based on pump rewind commands in the CareLink™ system. Results: Mean EIS use lifetime was 6.74 days, with >70% of sets used for more than 6 days. No user complaint was received during limited launch. The EIS set change rate at 7 days (168 hrs) was 48.2%, and was comparable to the 48.9% rate of 3-day sets at 3 days (72 hrs). In addition, CareLink™ data indicated that while users with a total daily dose (TDD) of insulin less than 40 U may not require an asynchronous reservoir fill, some users with higher TDD did asynchronously and successfully change their reservoirs while retaining the infusion set. Conclusion: In the OUS limited EIS launch, the EIS performed similarly to the pivotal trial results, with no user complaints. As expected, pump users with TDD less than 40 U changed the infusion set and reservoir at the same time on the seventh day. The product has launched in the US and may potentially reduce user burden by effectively halving the number of required infusion set changes compared to standard 3-day sets. Disclosure T.Kwa: Employee; Medtronic. G.Zhang: Employee; Medtronic. A.Roy: Employee; Medtronic. M.Liu: Employee; Medtronic. E.Anselmo: Employee; Medtronic. J.Shin: Employee; Medtronic. O.Cohen: Employee; Medtronic. S.Chattaraj: Employee; Medtronic.