Background and Aims

In the previous studies, we reported that using a new fluid path design, H-Cap extended wear infusion set (HEWS or EWIS Gen1), extended the infusion set wear time for continuous subcutaneous insulin delivery (CSII) for patients with insulin requiring diabetes. In this study, a newly designed Extended Wear Infusion Set (EWIS Gen2) was evaluated for safety and efficacy for up to 7 days of CSII.

Methods

Twenty-six subjects were recruited with a target of 20 subjects (4 EWIS Gen2 each, until 7-day wear) completing the 1-center, prospective, open label one arm study .

Results

Twenty-one subjects participated in the study with 20 completed, resulting in 82 insertions and 78 wears. After 7 days, the failure rate, including insertion failures, was 19.5% for the EWIS, compared to 50.7% for the Quick-set™ (control) and 30.6% for the HEWS in the previous study, and 64% for Quick-set™ as reported in Patel[1] et al study. When a EWIS was successfully used for 7 days, there was no increase in hyperglycemia or daily insulin requirements.

[1] Patel PJ, Benasi K, Ferrari G, et al. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014; 16:15-19.

Conclusions

Clinical data obtained from this one arm study confirmed the new fluid path function for extending infusion set wear time. The new EWIS design provided greater than 80.5% survival when worn for 7 days (85% excluding insertion failure), which was a statistically significant improvement when compared to survival curves of a 3-day set worn for 7-days.