Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes

Inclusion Criteria: * Informed consent signed * Patients with T1D since more than 1 year * Adults 18+years * Patients under sensor augmented pump for at least 6 months * Hybrid closed-loop users willing to switch to manual mode 15 days before study * Patients with calculated insulin-to-carb ratio and correction factor * Patients with total daily insulin above 30 insulin units * Patients with correction factor below 3.5 mmol/L * No severe hypoglycemic or ketoacidosis episode requiring third-party intervention within the past 12 months * Active users of Teflon infusion sets * Patients willing to use a smartphone interface to use their pump and to answer study questionnaires Exclusion Criteria: * Patients with T2D * Patients with T1D under multiple daily injections * Patients using Apidra and not willing to switch to NovoRapid / Fiasp / Humalog * Patients with history of skin diseases (e.g. generalized eczema, plan lichen, psoriasis) * Patients with known allergy to some insulins * Clarke's score ≥ 4 (hypoglycemia unawareness) * Severe late complications of diabetes, like severe neuropathy, non-stabilized proliferative retinopathy, EGF \< 30 mL/min, myocardial infarction or stroke within the last 3 months * Glycated hemoglobin HbA1c \> 8.5 % at screening visit * Medications interacting with glucose homeostasis (e.g. steroids) * Pregnant of breastfeeding women * Planned operation / MRI / CT requiring removal of infusion pad over the 15 days of the study * Planned travel over the 15 days of the study * Persons under guardianship or incapable of judgement