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 insulininjections

5. Patient glycaemic target is not achieved or suboptimal according to internationalconsensus: HbA1c level equal and greater than 7% and less than 12% at the time ofenrolment, 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 insulinaspart ")

7. Subject and their parent(s)/guardian(s) able to receive and understand studyinformation, give written informed consent, and easily participate to the trial

8. Subject and their parent(s)/guardian(s) affiliated to the French social securitysystem

9. Subject and their parent(s)/guardian(s) have the cognitive ability and cansuccessfully operate all study devices and can adhere to the protocol

Exclusion Criteria:

1. Patient unable to tolerate tape adhesive, catheter or had any unresolved adverseskin condition and intolerance to steel

2. Patient not willing to perform finger stick blood glucose measurements required bythe system and/or routine diabetes management

3. Patient with behaviour/lifestyle not compatible with optimal management of insulintherapy or deemed to be at significant risk of severe events (e.g. severehypoglycaemia, diabetic ketoacidosis)

4. Unstable diabetic retinopathy

5. Pregnant women or planning to become pregnant during the study or breast-feeding

6. Patient abusing alcohol

7. Patient using DPP-4 inhibitor, GLP-1 agonists, metformin, or SGLT2 inhibitors duringthe last 3 months prior screening

8. Patient already participating in another interventional study

9. Patient currently using a hybrid closed loop system or patient who has stopped usageof Hybrid Closed loop system for less than 3 months

10. Patient under the protection of justice or under guardianship or curatorship, orhospitalised under duress or admitted to a health or social care establishment forpurposes other than those of this investigation.