trial comparing metabolic efficiency of islet graft to intensive insulin therapy for type 1 diabetes's treatment

Conditions: Diabetes Mellitus, Type 1

Summary: efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable diabetes and patients who underwent kidney transplantation.

efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable type 1 diabetes versus patients with unstable type 1 diabetes and who underwent kidney transplantation.

Eligibility criteria:
inclusion criteria: * patient with type 1 diabetes or c-peptide negative diabetes diabetes duration \> 5 years * no residual insulin secretion (plasmatic basal and stimulated c-peptide \< 0.3 ng/ml) * hba1c considered acceptable by the selection committee * insulin needs \< 0.85 iu/kg/day * islet cell infusion after kidney graft * patient with terminal renal failure and functional kidney graft for at least 6 months (creatinine clearance greater than or equal to 35 ml/min) * patient whose glycaemic control obtained with insulin therapy could threaten kidney graft survival and/or significantly alter quality of life. this situation is assessed by a diabetologist * islet cell infusion only: patient with major glycaemic variability despite proper intensive insulin therapy, closely monitored by a diabetologist. poor glucose control, assessed by a diabetologist, endangers the patient's life and/or significantly alters personal, social, professional and family quality of life. at least one of these criteria must be fulfilled : * hypoglycaemia unawareness, blood glucose level \< 3mmol/l or 0.54 mg/l * at least 2 severe hypoglycaemia events (defined by the necessity of a third party's assistance) per year or a ketoacidosis requiring patient's hospitalization during the last year. * impairment of quality of life or life-threat for patient or other persons, or progressive complications despite optimal insulin therapy * social security membership or benefit from social welfare exclusion criteria: * age\ 65 * diabetes duration \< 5 years * criteria specifically related to the islet intraportal injection procedure: hemostasis problem, haemoglobin level \ 20%). * criteria related to diabetes complications : * non-stabilized proliferating diabetic retinopathy * creatininaemia \> 16 mg/dl * exclusion criteria non-specifically related to islet infusion: evolutive vascular disease, evolutive cardiopathy (especially myocardial infarction less than 6 months ago, cerebrovascular stroke less than 6 months ago, evolutive arteritis with trophic disorders) ; systemic infection including hepatitis c and hiv ; leuconeutropenia ; thrombocytopenia, non-stabilized neoplastic pathology ; pregnancy or project of pregnancy within the next 24 months ; poor therapeutic compliance * criteria related to immunosuppressive protocol : renal failure (glomerular filtration \ 0.5 g/24h ; non-treated hyperlipidemia (ldl-c \> 130 mg/dl) ; blood pressure \> 160/100 mmhg * clinical insulin resistance : assessed by patient's weight, bmi and exogenous insulin requirements (bmi \> 30 kg/m² or insulin dose \> 0.85 ui/kg/day)

Keywords: islet cell transplantation metabolic diseases endocrine system diseases