This study is a multi-center, single arm study in insulin-requiring adult subjects with type 1 diabetes treated with MDI (basal and bolus) therapy.~The total study duration will be approximately 10 weeks long for each participant.~The study consists of a run-in (phase 1) and study phases 2, 3 and 4.~Phase 1:~The purpose of the run-in phase is to collect baseline HbA1c and blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current MDI therapy.~Phase 2:~All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose calculator (InPen™ Diabetes Management App), and will continue their own SMBG, iscCGM or RT-CGM for two weeks.~Phase 3:~Subjects will continue on the InPen and InPen App for another two weeks utilizing the HCP insights gained during the titration follow-up visit.~Phase 4:~All subjects will utilize the InPen™ system consisting of:~InPen™ and InPen™ Diabetes Management App~Guardian™ 4 system (RT-CGM)~Guardian™ 4 sensor~Guardian™ 4 transmitter~Guardian™ 4 app
The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study.