Diabeloop for Highly Unstable Type 1 Diabetes

Exclusion Criteria

• •patient with type 2 diabetes
• •age \< 22 years old
• •patient without any social or familial support able to intervene in case of severe hypoglycemic event
• •any permanent and severe condition able to interact with the normal course of the study
• •patient with insulin-resistance defined by insulin requirements \> 1.5U/kg/d
• •patient with a daily dose of insulin required greater than 90 units
• •patient receiving a total daily dose of insulin less than 8 U
• •use of any insulin that is not 100 U/mL fast-acting insulin analog
• •patient suffering from a serious illness or a treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment of steroids)
• •patient having severe problems of uncorrected hearing and/or visual acuity
• •patient who is unable to understand and perform all the instructions provided by Diabeloop SA
• •patient not willing to perform ≥4 finger stick blood glucose measurements daily
• •patients that have frequent exposure to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
• •patient who has had a pancreatectomy or who has pancreatic malfunctions
• •patient having severely altered renal function (Creatinine clearance \< 30ml/min)
• •patient on dialysis
• •pregnancy or breast-feeding patient, or project of pregnancy during the next 6 months
• •lack of effective contraception in women of childbearing potential
• •all conditions excluding participation to clinical research as defined in France