This MiniMed 780G system with Guardian 4 Sensor (G4S) study is a pre-market, prospective, open-label, multi-center, randomized crossover trial in paediatric subjects (2-6 years old) with type 1 diabetes. The study consists of a run-in phase, a study phase and a continuation phase.~Run-in Phase:~The purpose of the run-in phase (2 to 4 weeks) is to train subject's parent(s)/legal guardian(s) on the MiniMed 780G system in Manual Mode with Suspend before low (SBL) activated and to collect 2 weeks of baseline data. At the end of Run-in Phase, subjects will be randomized into one of two sequences (A or B).~Study Phase:~Sequence A: subjects will use the Advanced Hybrid Closed Loop (AHCL) therapy (i.e. MiniMed 780G system in Auto Mode) for 12 weeks (Treatment). The washout phase of 2 weeks will be followed by a 12-week phase where subjects will use predictive low-glucose suspend (i.e. 780G system in Manual Mode with SBL activated) (Control).~Sequence B: subjects will continue to use predictive low-glucose suspend (i.e. 780G system in Manual Mode with SBL activated) (Control). After a washout phase of 2 weeks, subjects will use Advanced Hybrid Closed Loop (AHCL) therapy (i.e. MiniMed 780G system in Auto Mode) for 12 weeks (Treatment).~During washout period all the subjects will use MiniMed 780G system in Manual Mode with SBL activated.~Continuation Phase:~For the duration of the 26 week continuation phase, all enrolled subjects will be using the MiniMed 780G system in Auto Mode.
The purpose of this study is to demonstrate the safety and performance of the MiniMed™ 780G system in paediatric subjects (2-6 years old) with type 1 diabetes in a home setting.