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| ID | Type | Description | Link |
|---|---|---|---|
| A111/2025-06-290/001 | Other Identifier | Scientific and ethics committee of the Montpellier University Hospital |
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| Name | Class |
|---|---|
| University Hospital, Grenoble | OTHER |
| University Hospital, Toulouse | OTHER |
| University Hospital, Strasbourg | OTHER |
| University Hospital, Lille |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial pancreas transplant | Islet after pancreas transplant failure | ||
| Initial islet transplant | Islet after islet transplant failure |
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| Measure | Description | Time Frame |
|---|---|---|
| Islet graft success | Assessed using Igls criteria (optimal or good graft function classification) based on C-peptide, insulin use, hemoglobin A1c, and severe hypoglycemia | Baseline, 3 months, 1 year, 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control_Glycated hemoglobin (HbA1c) level | HbA1c level, measured by HPLC method | Baseline, 3 months, 1 year, 5 years |
| Glycemic Control_Percentage of individuals with HbA1c < 7% and no severe hypoglycemia |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control_Time in range (70-180 mg/dL) | Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 180 mg/dL | Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Time in tight range (70-140 mg/dL) |
Inclusion Criteria:
Exclusion Criteria:
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Adults with type 1 diabetes who underwent prior beta-cell replacement therapy (pancreas or islet transplantation) and subsequent islet re-transplantation after graft failure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Orianne OV Villard, MD | Contact | +33 467 338 382 | orianne.villard@chu-montpellier.fr | |
| Roxane RD Descaillot | Contact | roxanedescaillot@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University Hospital | Recruiting | Montpellier | 34000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37105208 | Background | Chetboun M, Drumez E, Ballou C, Maanaoui M, Payne E, Barton F, Kerr-Conte J, Vantyghem MC, Piemonti L, Rickels MR, Labreuche J, Pattou F; Collaborative Islet Transplant Registry (CITR) Investigators study group. Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry. Lancet Diabetes Endocrinol. 2023 Jun;11(6):391-401. doi: 10.1016/S2213-8587(23)00082-7. Epub 2023 Apr 24. | |
| 35864198 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| University Hospital, Paris | OTHER |
| The Civil Hospitals, Lyon | UNKNOWN |
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| 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 | 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 | Baseline, 3 months, 1 year, 5 years |
| Beta-Cell Function_Severe hypoglycemia events | Percentage of individual with severe hypoglycemia events | 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 | Baseline, 3 months, 1 year, 5 years |
| Immunological Outcomes_Donor-specific antibodies (DSA) | Presence and specificity of donor-specific antibodies (DSA) with classification :
| Baseline, 3 months, 1 year, 5 years |
| Immunological Outcomes_Autoantibodies | Dosage of antibodies anti-GAD, anti-IA2, anti-insulin, and anti-ZnT8 | 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 | Baseline, 3 months, 1 year, 5 years |
| Safety of islet re-transplantation_Renal function eGFR | Estimated GFR from serum creatinine level | Baseline, 3 months, 1 year, 5 years |
| Safety of islet re-transplantation_Albuminuria | Measurement of albuminuria or proteinuria | 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 | 3 months, 1 year, 5 years |
| Safety of islet re-transplantation_Mortality | Patient death | 3 months, 1 year, 5 years |
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 140 mg/dL
| Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Time below range 70 mg/dL | Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 54 mg/dL | Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Time below range 54 mg/dL | Continuous Glucose Monitoring (CGM) measured time with glucose below 54 mg/dL | Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Time above range 180 mg/dL | Continuous Glucose Monitoring (CGM) measured time with glucose between 180 and 250 mg/dL | Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Time above range 250 mg/dL | Continuous Glucose Monitoring (CGM) measured time with glucose above 250 mg/dL | Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Mean glucose | Continuous Glucose Monitoring (CGM) derived-metrics | Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Coefficient of variation | Continuous Glucose Monitoring (CGM) derived-metrics | Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Glycemic risk index | Continuous Glucose Monitoring (CGM) derived-metrics | Baseline, 3 months, 1 year and 5 years |
| Glycemic control_Glucose Management Indicator (GMI) | Continuous Glucose Monitoring (CGM) derived-metrics | Baseline, 3 months, 1 year and 5 years |
| Background |
| Maanaoui M, Chetboun M, Top I, Elsermans V, Kerr-Conte J, Le Mapihan K, Defrance F, Gmyr V, Hubert T, Labalette M, Hazzan M, Vantyghem MC, Pattou F. The challenge of HLA donor specific antibodies in the management of pancreatic islet transplantation: an illustrative case-series. Sci Rep. 2022 Jul 21;12(1):12463. doi: 10.1038/s41598-022-16782-3. |
| 30223084 | Background | Wojtusciszyn A, Branchereau J, Esposito L, Badet L, Buron F, Chetboun M, Kessler L, Morelon E, Berney T, Pattou F, Benhamou PY, Vantyghem MC; TREPID group. Indications for islet or pancreatic transplantation: Statement of the TREPID working group on behalf of the Societe francophone du diabete (SFD), Societe francaise d'endocrinologie (SFE), Societe francophone de transplantation (SFT) and Societe francaise de nephrologie - dialyse - transplantation (SFNDT). Diabetes Metab. 2019 Jun;45(3):224-237. doi: 10.1016/j.diabet.2018.07.006. Epub 2018 Sep 14. |
| 29528967 | Background | Rickels MR, Stock PG, de Koning EJP, Piemonti L, Pratschke J, Alejandro R, Bellin MD, Berney T, Choudhary P, Johnson PR, Kandaswamy R, Kay TWH, Keymeulen B, Kudva YC, Latres E, Langer RM, Lehmann R, Ludwig B, Markmann JF, Marinac M, Odorico JS, Pattou F, Senior PA, Shaw JAM, Vantyghem MC, White S. Defining Outcomes for beta-cell Replacement Therapy in the Treatment of Diabetes: A Consensus Report on the Igls Criteria From the IPITA/EPITA Opinion Leaders Workshop. Transplantation. 2018 Sep;102(9):1479-1486. doi: 10.1097/TP.0000000000002158. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |