Extended Follow-Up After Islet Transplantation in T1D

National Institute of Allergy and Infectious Diseases (NIAID)75 enrolled

Overview

The purpose of this study is to provide patients who have received at least one islet transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT) clinical trial with maintenance immunosuppressive medications and to collect information about the safety of the medications and islet function.

After islet-cell transplantation in the CIT studies\*, each subject receives maintenance immunosuppressive medications. The purpose of this protocol is to collect additional follow-up for safety and efficacy from CIT subjects with graft function after their completion in their CIT parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their CIT parent study. \*CIT parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes (T1D)Islet Transplantation

Interventions

Maintenance Immunosuppressive TreatmentDRUG

All immunosuppressive and immunomodulatory therapies are used presently to prevent rejection of transplanted islet cells. The agents listed are those used in the parent trials and continued in this trial, CIT08.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who have received an islet transplant during participation in the following Clinical Islet Transplantation (CIT) parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811) * A functioning pancreatic islet graft (e.g., absence of graft failure as defined in parent study) requiring immunosuppression * Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation * Ability to provide written informed consent * Resident of the United States of America * Documentation of the existence or lack of health insurance coverage and whether immunosuppressants are covered. Exclusion Criteria: * For female subjects-Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation * For male subjects-Intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. * Received an islet transplant in a non-CIT research study * Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.

Locations (8)

University of California, San Francisco

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Duration of sustained islet allograft function

A C-peptide \>/= 0.3 ng/mL at 0, 60, or 90 minutes after a Mixed-Meal Tolerance Test (MMTT) will be considered evidence of insulin production by transplanted islets

Time frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant

Secondary Outcomes

Serum creatinine and calculated eGFR at each annual study visit

Measured as part of each annual follow-up evaluation

Time frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant

Incidence of serious adverse events (SAEs) during the 12-month period preceding each annual study visit

Insulin usage will be estimated from the one-week self report values

Time frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant

Insulin requirements during a one-week period preceding each annual study visit

Insulin usage will be estimated from the one-week self report values

Time frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant

Incidence of severe hypoglycemic events during the 12-month period preceding each annual study visit

Numbers of severe hypoglycemic events will be estimated from the self report values obtained at each follow-up visit. Defined as an event with one of the following symptoms: memory loss; confusion; uncontrollable behavior; irrational behavior; unusual difficulty in awakening; suspected seizure; seizure; loss of consciousness; or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level \<54 mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, IV glucose, or glucagon administration.

Time frame: 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months, 132 months and 144 months

Data from ClinicalTrials.gov

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