Islet transplantation and pancreas transplantation are established therapeutic options for selected individuals with type 1 diabetes experiencing severe glycemic instability and recurrent hypoglycemia. Although these approaches significantly improve glycemic management and quality of life, long-term graft survival remains limited, with a progressive decline in beta-cell function over time. The clinical benefit-risk profile of islet re-transplantation after graft failure remains poorly defined, and outcomes following repeat islet transplantation after prior islet graft failure have not been specifically evaluated. Repeated exposure to multiple donors may increase the risk of alloimmunization, including the development of donor-specific antibodies , which may adversely affect graft survival and limit access to future transplantation. This multicenter retrospective cohort study aims to evaluate the efficacy and safety of islet re-transplantation in adults with type 1 diabetes after failure of initial beta-cell replacement (islet or pancreas transplantation), with outcomes assessed at 3 months, 1 year, and 5 years.
Study Type
OBSERVATIONAL
Enrollment
20
Montpellier University Hospital
Montpellier, France
RECRUITINGIslet graft success
Assessed using Igls criteria (optimal or good graft function classification) based on C-peptide, insulin use, hemoglobin A1c, and severe hypoglycemia
Time frame: Baseline, 3 months, 1 year, 5 years
Glycemic Control_Glycated hemoglobin (HbA1c) level
HbA1c level, measured by HPLC method
Time frame: Baseline, 3 months, 1 year, 5 years
Glycemic Control_Percentage of individuals with HbA1c < 7% and no severe hypoglycemia
Time frame: Baseline, 3 months, 12 months, 5 years
Beta-Cell Function_BETA-2 score
Derived from fasting glucose, paired fasting C-peptide, insulin dose and Hba1c and generates a single value between 0 and 42
Time frame: Baseline, 3 months, 1 year, 5 years
Beta-Cell Function_BETA score
Derived from fasting glucose, HbA1c, stimulated C-peptide, and absence of insulin or oral hypoglycemic agent use and generates a single value between 0 and 8
Time frame: Baseline, 3 months, 1 year, 5 years
Beta-Cell Function_Severe hypoglycemia events
Percentage of individual with severe hypoglycemia events
Time frame: Baseline, 3 months, 1 year, 5 years
Beta-Cell Function_Residual beta cell function
Percentage of individual with fasting plasma C-peptide \> 0.3 ng/mL
Time frame: Baseline, 3 months, 1 year, 5 years
Immunological Outcomes_Donor-specific antibodies (DSA)
Presence and specificity of donor-specific antibodies (DSA) with classification : * Preformed and de novo * Class I and II specificity * and Mean fluorescence intensity (MFI)
Time frame: Baseline, 3 months, 1 year, 5 years
Immunological Outcomes_Autoantibodies
Dosage of antibodies anti-GAD, anti-IA2, anti-insulin, and anti-ZnT8
Time frame: Baseline, 3 months, 1 year, 5 years
Safety of islet re-transplantation_Procedural complications of islet infusions
Reported of procedural complications of islet infusions such as portal thrombosis, hematoma, transfusion requirement
Time frame: Baseline, 3 months, 1 year, 5 years
Safety of islet re-transplantation_Renal function eGFR
Estimated GFR from serum creatinine level
Time frame: Baseline, 3 months, 1 year, 5 years
Safety of islet re-transplantation_Albuminuria
Measurement of albuminuria or proteinuria
Time frame: Baseline, 3 months, 1 year, 5 years
Safety of islet re-transplantation_Immunosuppression-related complications
Reported immunosuppression-related complications such as infections ; malignancy, cardiovascular events
Time frame: 3 months, 1 year, 5 years
Safety of islet re-transplantation_Mortality
Patient death
Time frame: 3 months, 1 year, 5 years
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