Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Diagnosis of type 1 diabetes
Prior beta-cell replacement therapy : islet transplantation or pancreas transplantation
Islet re-transplantation performed after 2005
Disqualifiers
Missing or incomplete data preventing assessment of the primary outcome
Patients who did not meet inclusion criteria
Trial population
Adults with type 1 diabetes who underwent prior beta-cell replacement therapy (pancreas or islet transplantation) and subsequent islet re-transplantation after graft failure.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 2 trial groupsGroup A: Initial pancreas transplant
Group B: Initial islet transplant
Trial outcomes
Primary outcomes
1
Islet 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 yearsSecondary outcomes
1
Glycemic Control_Glycated hemoglobin (HbA1c) level
HbA1c level, measured by HPLC method
Time frame
Baseline, 3 months, 1 year, 5 years2
Glycemic Control_Percentage of individuals with HbA1c < 7% and no severe hypoglycemia
Time frame
Baseline, 3 months, 12 months, 5 years3
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 years4
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 yearsOther outcomes
1
Glycemic control_Time in range (70-180 mg/dL)
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 180 mg/dL
Time frame
Baseline, 3 months, 1 year and 5 years2
Glycemic control_Time in tight range (70-140 mg/dL)
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 140 mg/dL
Time frame
Baseline, 3 months, 1 year and 5 years3
Glycemic control_Time below range 70 mg/dL
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 54 mg/dL
Time frame
Baseline, 3 months, 1 year and 5 years4
Glycemic control_Time below range 54 mg/dL
Continuous Glucose Monitoring (CGM) measured time with glucose below 54 mg/dL
Time frame
Baseline, 3 months, 1 year and 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
University Hospital, Grenoble
Collaborator
University Hospital, Toulouse
Collaborator
University Hospital, Strasbourg
Collaborator
University Hospital, Lille
Collaborator
University Hospital, Paris
Collaborator
The Civil Hospitals, Lyon
Collaborator
Source ClinicalTrials.gov