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NCT Number: NCT07666789

Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement

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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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Islets of Langerhans Transplantation Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montpellier University Hospital

Montpellier, 34000, France

Location status: Recruiting

Location contact

Orianne OV Villard, MD

CONTACT

[email protected]

+33 467 338 382

Orianne OV Villard, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of type 1 diabetes
  • Prior beta-cell replacement therapy : islet transplantation or pancreas transplantation
  • Islet re-transplantation performed after 2005
  • Islet re-transplantation performed after documented beta cell graft failure, defined by undetectable C-peptide and/or recurrence of severe hypoglycemia on insulin therapy
  • Availability of clinical and biological data required for assessment of study outcomes

Exclusion criteria

  • Missing or incomplete data preventing assessment of the primary outcome
  • Patients who did not meet inclusion criteria

Treatment and study plan

Primary outcomes

  1. Islet graft success

    Time frame: Baseline, 3 months, 1 year, 5 years

    Assessed using Igls criteria (optimal or good graft function classification) based on C-peptide, insulin use, hemoglobin A1c, and severe hypoglycemia

Secondary outcomes

  1. Glycemic Control_Glycated hemoglobin (HbA1c) level

    Time frame: Baseline, 3 months, 1 year, 5 years

    HbA1c level, measured by HPLC method

  2. Glycemic Control_Percentage of individuals with HbA1c < 7% and no severe hypoglycemia

    Time frame: Baseline, 3 months, 12 months, 5 years

  3. Beta-Cell Function_BETA-2 score

    Time frame: Baseline, 3 months, 1 year, 5 years

    Derived from fasting glucose, paired fasting C-peptide, insulin dose and Hba1c and generates a single value between 0 and 42

  4. Beta-Cell Function_BETA score

    Time frame: Baseline, 3 months, 1 year, 5 years

    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

  5. Beta-Cell Function_Severe hypoglycemia events

    Time frame: Baseline, 3 months, 1 year, 5 years

    Percentage of individual with severe hypoglycemia events

  6. Beta-Cell Function_Residual beta cell function

    Time frame: Baseline, 3 months, 1 year, 5 years

    Percentage of individual with fasting plasma C-peptide > 0.3 ng/mL

  7. Immunological Outcomes_Donor-specific antibodies (DSA)

    Time frame: Baseline, 3 months, 1 year, 5 years

    Presence and specificity of donor-specific antibodies (DSA) with classification :

    • Preformed and de novo
    • Class I and II specificity
    • and Mean fluorescence intensity (MFI)

  8. Immunological Outcomes_Autoantibodies

    Time frame: Baseline, 3 months, 1 year, 5 years

    Dosage of antibodies anti-GAD, anti-IA2, anti-insulin, and anti-ZnT8

  9. Safety of islet re-transplantation_Procedural complications of islet infusions

    Time frame: Baseline, 3 months, 1 year, 5 years

    Reported of procedural complications of islet infusions such as portal thrombosis, hematoma, transfusion requirement

  10. Safety of islet re-transplantation_Renal function eGFR

    Time frame: Baseline, 3 months, 1 year, 5 years

    Estimated GFR from serum creatinine level

  11. Safety of islet re-transplantation_Albuminuria

    Time frame: Baseline, 3 months, 1 year, 5 years

    Measurement of albuminuria or proteinuria

  12. Safety of islet re-transplantation_Immunosuppression-related complications

    Time frame: 3 months, 1 year, 5 years

    Reported immunosuppression-related complications such as infections ; malignancy, cardiovascular events

  13. Safety of islet re-transplantation_Mortality

    Time frame: 3 months, 1 year, 5 years

    Patient death

Other outcomes

  1. Glycemic control_Time in range (70-180 mg/dL)

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 180 mg/dL

  2. Glycemic control_Time in tight range (70-140 mg/dL)

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 140 mg/dL

  3. Glycemic control_Time below range 70 mg/dL

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 54 mg/dL

  4. Glycemic control_Time below range 54 mg/dL

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) measured time with glucose below 54 mg/dL

  5. Glycemic control_Time above range 180 mg/dL

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) measured time with glucose between 180 and 250 mg/dL

  6. Glycemic control_Time above range 250 mg/dL

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) measured time with glucose above 250 mg/dL

  7. Glycemic control_Mean glucose

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) derived-metrics

  8. Glycemic control_Coefficient of variation

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) derived-metrics

  9. Glycemic control_Glycemic risk index

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) derived-metrics

  10. Glycemic control_Glucose Management Indicator (GMI)

    Time frame: Baseline, 3 months, 1 year and 5 years

    Continuous Glucose Monitoring (CGM) derived-metrics

Study contacts

Contact information is provided by the study sponsor or research team.

Orianne OV Villard, MD

CONTACT

[email protected]

+33 467 338 382

Roxane RD Descaillot

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • The Civil Hospitals, Lyon
  • University Hospital, Grenoble
  • University Hospital, Lille
  • University Hospital, Paris
  • University Hospital, Strasbourg
  • University Hospital, Toulouse

Registry information

Official study title

Efficacy and Safety of Islet Re-transplantation After Failure of Beta-cell Replacement

Acronym: MULT-ILOT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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