Objective: The durability of wearable devices, e.g., insulin infusion sets (IIS), is challenged by external factors such as friction, movement, stretch, moisture, and skin viscoelasticity. Such factors are difficult to investigate in non-clinical settings. We assessed 3 new adhesive patches and compared them to those used with current Medtronic infusion sets to determine which would be suitable for an extended wear infusion set with intended wear time of up to 7 days.

Method: Seventy-five adults were recruited in 3 studies to wear 2 patch variants each on conventional IIS sites, for up to 8 days. Non-functional Medtronic pumps were used to simulate use conditions. The primary outcome was wear time. Secondary outcomes included edge lift and descriptive user feedback (e.g., appearance, comfort, irritation score, residue upon removal, and removal discomfort).

Results: The results (Figure 1) demonstrated that the 7-day survival rate for existing IIS patches varied from ∼70% to ∼90%. These data indicated that the hub form factor played an insignificant role in the adhesive patch wear time. Two of three new adhesive patches had a 7-day survival rate ≥95% without significantly impacting user experience (i.e., wear comfort or skin reactions).

Conclusion: In the simulated-use studies, two new adhesive patches met the primary and secondary outcomes for use with an extended wear infusion set.


G. Zhang: None. S. Chattaraj: Employee; Self; Medtronic. E. Anselmo: Employee; Self; Medtronic. L. Hoffman: None. M. Tran: None. S. Bondy: Employee; Self; Medtronic. Stock/Shareholder; Self; Medtronic.

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