Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System

Inclusion Criteria

• •1. Patients living with Type 1 diabetes:
• •* adults aged 18 to 75 years old (included)
• •* children/adolescents aged 7 or older
• •2. Total daily dose of insulin ≥ 10 units per day \& weighing \>22 Kg
• •3. Patient and their parent(s)/guardian(s) trained and able to count carb
• •4. Current or previous insulin pump user or patient treated with multiple insulin injections
• •5. Patient glycaemic target is not achieved or suboptimal according to international consensus: HbA1c level equal and greater than 7% and less than 12% at the time of enrolment, or TIR \< 70%, or TBR \>4%
• •6. Any type of rapid insulin with a total daily insulin in the range of 10-60 IU (unauthorized use of insulin supplements by pen injector): Humalog™, Lyumjev (insulin lispro injection), Novorapid (insulin aspart) or FIASP® (" faster insulin aspart ")
• •7. Subject and their parent(s)/guardian(s) able to receive and understand study information, give written informed consent, and easily participate to the trial
• •8. Subject and their parent(s)/guardian(s) affiliated to the French social security system
• •9. Subject and their parent(s)/guardian(s) have the cognitive ability and can successfully operate all study devices and can adhere to the protocol