Efficacy of Closed-loop Insulin Therapy in Adults Prone to Hypoglycemia

Inclusion Criteria

• •1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
• •2. Use of an insulin pump for at least 6 months
• •3. Age ≥18 .0 years old
• •4. HbA1c level \<10.5% at screening
• •5. Clarke score \>3 and/or experience of severe hypoglycemia during the previous 6 months
• •6. For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• •7. Willingness not to use glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study. This does not concern treatment with Metformin active and stable for more than 3 months prior the inclusion. Moreover, the use of SGLT2 inhibitors is not allowed in the 3 months prior to enrollment.
• •8. Willingness to suspend use of any personal CGM for the duration of the clinical trial
• •9. Willingness to establish network connectivity on at least a weekly basis
• •10. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog). Patients using glulisine (Apidra) may switch to lispro or aspart at least one month prior to enrollment.
• •11. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
• •12. Subject is covered by social health or similar insurance
• •13. Informed consent form signed