diabeloop for highly unstable type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Brittle; Closed-Loop

Summary: feasibility study, comparing experimental treatment (dblhu closed-loop system) with reference treatment (low glucose predictive suspend system) in 7 patients going through a series of n-of-1 trials. each n-of-1 trial consists in a prospectively planned, multiple crossover study in a single individual. two blocks of two periods of four weeks each (closed loop or open loop) will be conducted. within each block, the sequence closed loop-open loop or open loop-close loop is randomized. outcomes will be analyzed on the third and fourth weeks of period. a remote monitoring system managed by specialized nurse on behalf of diabetologist, is provided in closed-loop session. an extension period of 48 weeks with the dblhu system (closed-loop condition) will be performed at the end of the crossover study phase in real life conditions (without remote monitoring).


Eligibility criteria:
inclusion criteria: * subject (aged 22 or more) with type 1 diabetes for at least 5 years and confirmed c peptide negative * treated with continuous subcutaneous insulin infusion (csii) for ≥ 6 months, * trained to carbohydrate counting/flexible insulin therapy, * subject that had experienced, despite optimal diabetes management and prior to any equipment with smartguard technology, glucose instability as defined by at least 2 of the following criteria which would have led to eligibility for pancreatic islet transplantation: * occurrence of at least 1 severe hypoglycemic episode during the past 12 months (need for third party), * occurrence of ketoacidosis (hospitalization in icu) without explanation * impaired awareness of hypoglycemia (clark score ≥ 4; gold score \> 4) * glucose levels: standard deviation \> 50% of the arithmetic mean value on glucose meter or \> 40 mg/dl on cgm on a 14-day recording * glucose levels: mage (mean amplitude of glucose excursions) index \> 60 mg/dl * glucose levels: coefficient of variation (cv) \> 36% * with persisting extreme glucose variability despite optimal medical care * with contra-indication or no agreement to undertake pancreatic islet transplantation or pancreas transplantation. * subject willing to wear the dblhu system continuously throughout the study 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

Keywords: artificial pancreas very unstable type 1 diabetes