EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET

"All subjects will be instructed to change the investigational infusion sets (PIS) every 246 hours (10 days \& 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.~defined as any one of the following: After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of \<6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.~if study 1 is successful, participants will enter study 2; , the same study designed will be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users"