It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic islet transplantation for the treatment of type 1 diabetes. 19 patients with type 1 diabetes will be included and ideally distributed evenly: patients with unstable diabetes without renal insufficiency (AI group for "islet alone" by the international customary determination) and patients with a functioning kidney transplant (IAK group for "islet after kidney"). The main endpoint will be defined by the restoration of normal glycemic control without insulin at 6 months after graft.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Saint Louis hospital
Paris, Île-de-France Region, France
RECRUITINGrestoration of normal glycemic control without insulin
the restoration of normal glycemic control without insulin therapy will be evaluated by measuring \- A fasting glucose (\> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months from day 0.
Time frame: 6 months after graft
Restoration of normal glycemic control without insulin for a year
Time frame: 1 year
Obtaining an improvement in glycemic control
HbA1c \<6.5%, with lower insulin doses by 30%
Time frame: within 2 years after inclusion
Obtaining a remission of diabetes
The remission of diabetes is defined by the normality of blood glucose or insulin without lHbA1c. The normality of blood glucose is defined below 1.20 g/L and postprandial fasting glycemia less than 1.60 g/L in the book self-monitoring (including 6/7 blood glucoses during the previous 3 days evaluation visit). Normal HbA1c is defined as less than 6.5%.
Time frame: within 2 years after inclusion
Improved metabolic profile determined by the OGTT and hyperglycemic clamp
Time frame: within 2 years after inclusion
Decreased glycemic variability
defined on blood glucose and / or glucose holter
Time frame: within 2 years after inclusion
Reduction of oxidative stress assessed by the urinary excretion of 24 hours of 8-iso-PGF2 rates.
Time frame: within 2 years after inclusion
Decrease in the frequency, severity or poor perception of hypoglycaemia defined Hypo score
Time frame: within the 2 years after inclusion
quality of life
defined by questionnaires DQOL and SF-36
Time frame: within 2 years after inclusion
term graft survival
defined by the rate of C-peptide
Time frame: within 2 years of inclusion
beta-cell function
based on beta-score
Time frame: 2 years
potential of each infusion of islets
number of IEQ/kg of recipient required to reduce the daily insulin dose of 1 unit
Time frame: within 2 years after inclusion
degenerative complications of diabetes
Time frame: 2 years
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