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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Iterative injection of pancreatic islets (minimum: 250,000 IEQ / injection or 3500 IEQ / kg / injection) with a threshold required total of 11,000 IEQ / kg in 2 or 3 injections per patient)
University Hospital, Department of Endocrinology
Strasbourg, Alsace, France
University Hospital, Department of Endocrinology
Grenoble, Auvergne-Rhône-Alpes, France
HCL Sud, Department of Endocrinology
Lyon, Auvergne-Rhône-Alpes, France
ß score evaluation 6 months after first infusion (group 1 'immediate registration on infusion waiting list') or 6 months after inclusion (group 2: 'delayed registration on infusion waiting list')
Metabolism evaluated by ß score. This score uses 4 intermediate scores ranging from 0 to 2 associated with the following 4 indicators: HbA1c, basal C peptide (or stimulated C-peptide), daily insulin dose (U/kg) or intake of oral antidiabetic drugs and fasting glycaemia. The total of the intermediate scores ranges from 0 to 8. Islet graft will be considered as successful if the ß score is equal to or greater than 6
Time frame: 6 months after first infusion (group 1) or 6 months after inclusion (group 2)
Evaluation of metabolism indicators : ß-score and individual analysis of the 4 components of the ß-score
Metabolism indicators at 6 and 12 months : ß-score (quantitative analysis by mean score comparison), individual analysis of the 4 components of the ß-score (HbA1c, basal C peptide (or stimulated C-peptide), daily insulin dose (U/kg) or intake of oral antidiabetic drugs and fasting glycaemia), lability index, ADRR score, Clarke score
Time frame: 6 and 12 months
Measure of quality of life (SF36, DQOL, DHP)
Measure of quality of life (SF36, DQOL, DHP) for Group 1 ('immediate registration on infusion waiting list'): at inclusion time, at 6 months and at 12 months after first infusion For Group 2 ('delayed registration on infusion waiting list'): at inclusion time, 6 months after inclusion, at 6 months and at 12 months after first infusion
Time frame: at inclusion time, at 6 months and at 12 months after first infusion (group 1) or after inclusion (group 2)
Cost evaluation of islet cell infusion
Cost comparison between islet cell infusion (group 1 'immediate registration on infusion waiting list')and intensive insulin therapy (group 2 'delayed registration on infusion waiting list') at 6 months, from a hospital perspective as well as a health-insurance system perspective
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University Hospital Gabriel Montpied, Department of Endocrinology
Clermont-Ferrand, Auvergne, France
University Hospital Besançon, Department of Endocrinology
Besançon, Franche-Comté, France
University Hospital, Department of General Surgery and Endocrinology
Lille, Hauts-de-France, France
University Hospital, Department of Endocrinology
Montpellier, Languedoc-Roussillon, France
University Hospital, Department of Endocrinology
Nancy, Lorraine, France
Hopitaux Universitaires de Genève, Department of Visceral Surgery and Transplant
Geneva, Switzerland
Time frame: 6 months
Evaluation of side effects and iatrogenic effects
Evaluation of side effects and iatrogenic effects at 6 months and 12 months after infusion
Time frame: at 6 months and 12 months after infusion