Background and Aims

This study was intended to test if a new fluid path design (H-Cap Connector) could extend the infusion set wear time. Both H-Cap extended wear set (HEWS) and control infusion set MiniMed™ Quick-set™(QS, a 3-day set worn upto 7-days in this study) were compared for percent of sets reaching 7-day use without set failure for insulin pump therapy in type 1 diabetes mellitus.

Methods

Forty subjects were recruited with a target of 20 subjects completing the study. This was a randomized, open-labeled, crossover study, with each subject being asked to wear 4 HEWS and 4 regular QS infusion sets (both from Medtronic MiniMed, Northridge, CA) until the infusion set failed or 7-day use was reached.

Results

Four subjects did not participate beyond randomization during the study. One subject withdrew after 4 wears. There were 144 wears of H-Cap extended wear set and 140 wears of QS. When an infusion set was successfully used for 7 days, there was no increase in hyperglycemia or daily insulin requirements. After 7 days, the failure rate was 50.7% for QS and 30.6% for HEWS.

Conclusions

Clinical data obtained from this prospective, randomized, controlled, one site study demonstrates significant higher 7-day survival of the HEWS in comparison to regular Quick-set in this study or in previously reported study on QS in Patel et. al. study [1]. 69.4% of the HEWS used, survived 7 days.

[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.