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Cited by 725Pancreatic function and diabetesDiabetes Management and ResearchDiabetes and associated disorders

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Improvement in Outcomes of Clinical Islet Transplantation: 1999–2010

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Barton, Franca B., Rickels, Michael R., Alejandro, Rodolfo, Hering, Bernhard J., Wease, Stephen, Naziruddin, Bashoo, Oberholzer, Jose, Odorico, Jon S., Garfinkel, Marc R., Levy, Marlon, Pattou, Francois, Berney, Thierry, Secchi, Antonio, Messinger, Shari, Senior, Peter A., Maffi, Paola, Posselt, Andrew, Stock, Peter G., Kaufman, Dixon B., Luo, Xunrong, Kandeel, Fouad, Cagliero, Enrico, Turgeon, Nicole A., Witkowski, Piotr, Naji, Ali, O’Connell, Philip J., Greenbaum, Carla, Kudva, Yogish C., Brayman, Kenneth L., Aull, Meredith J., Larsen, Christian, Kay, Tom W.H., Fernandez, Luis A., Vantyghem, Marie-Christine, Bellin, Melena, Shapiro, A.M. James·2012·Diabetes Care
DOI 10.2337/dc12-0063PMC PMC3379615
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Abstract

OBJECTIVE: To describe trends of primary efficacy and safety outcomes of islet transplantation in type 1 diabetes recipients with severe hypoglycemia from the Collaborative Islet Transplant Registry (CITR) from 1999 to 2010. RESEARCH DESIGN AND METHODS: A total of 677 islet transplant-alone or islet-after-kidney recipients with type 1 diabetes in the CITR were analyzed for five primary efficacy outcomes and overall safety to identify any differences by early (1999–2002), mid (2003–2006), or recent (2007–2010) transplant era based on annual follow-up to 5 years. RESULTS: Insulin independence at 3 years after transplant improved from 27% in the early era (1999–2002, n = 214) to 37% in the mid (2003–2006, n = 255) and to 44% in the most recent era (2007–2010, n = 208; P = 0.006 for years-by-era; P = 0.01 for era alone). C-peptide ≥0.3 ng/mL, indicative of islet graft function, was retained longer in the most recent era (P < 0.001). Reduction of HbA1c and resolution of severe hypoglycemia exhibited enduring long-term effects. Fasting blood glucose stabilization also showed improvements in the most recent era. There were also modest reductions in the occurrence of adverse events. The islet reinfusion rate was lower: 48% by 1 year in 2007–2010 vs. 60–65% in 1999–2006 (P < 0.01). Recipients that ever achieved insulin-independence experienced longer duration of islet graft function (P < 0.001). CONCLUSIONS: The CITR shows improvement in primary efficacy and safety outcomes of islet transplantation in recipients who received transplants in 2007–2010 compared with those in 1999–2006, with fewer islet infusions and adverse events per recipient.

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Figure 1 Islet allograft recipients (N = 677) registered in CITR according to type of transplant (n per year; top), induction immunosuppression at first infusion (% by year; center), and maintenance immunosuppression at first infusion (% by year; bottom). ITA, islet transplant alone.
Figure 1 Islet allograft recipients (N = 677) registered in CITR according to type of transplant (n per year; top), induction immunosuppression at first infusion (% by year; center), and maintenance immunosuppression at first infusion (% by year; bottom). ITA, islet transplant alone.CC BY-NC-ND · PubMed Central
Figure 2 A: Rates of insulin independence after allogeneic islet infusion (islet transplant alone and IAK), annually after last infusion. Left: By era (P = 0.02). Right: By induction immunosuppression category (P < 0.01). B: Durability of graft function (basal C-peptide ≥0.3 ng/mL) after the last infusion, by era (P < 0.001; left). The immediate drop at time 0 is occurrences of primary nonfunction (i.e., C-peptide never ≥0.3 ng/mL). In the most recent era, 95% of those who ever achieved insulin independence (II) retained graft function through 3 years after last infusion compared with 70% for those who never achieved II (P < 0.001; right). C: Percentage of patients with HbA1c <6.5% or drop by two percentage points (P = 0.03; left); and absence of severe hypoglycemic events regardless of complete graft failure (P = NS by era; there were insufficient data from 2007–2010; right). D: The percentage with HbA1c <6.5% or drop by 2% increases with increasing C-peptide level (P < 0.001; left), as does absence of severe hypoglycemic events (P < 0.001; right), annually after the last infusion. (A high-quality color representation of this figure is available in the online issue.)
Figure 2 A: Rates of insulin independence after allogeneic islet infusion (islet transplant alone and IAK), annually after last infusion. Left: By era (P = 0.02). Right: By induction immunosuppression category (P < 0.01). B: Durability of graft function (basal C-peptide ≥0.3 ng/mL) after the last infusion, by era (P < 0.001; left). The immediate drop at time 0 is occurrences of primary nonfunction (i.e., C-peptide never ≥0.3 ng/mL). In the most recent era, 95% of those who ever achieved insulin independence (II) retained graft function through 3 years after last infusion compared with 70% for those who never achieved II (P < 0.001; right). C: Percentage of patients with HbA1c <6.5% or drop by two percentage points (P = 0.03; left); and absence of severe hypoglycemic events regardless of complete graft failure (P = NS by era; there were insufficient data from 2007–2010; right). D: The percentage with HbA1c <6.5% or drop by 2% increases with increasing C-peptide level (P < 0.001; left), as does absence of severe hypoglycemic events (P < 0.001; right), annually after the last infusion. (A high-quality color representation of this figure is available in the online issue.)CC BY-NC-ND · PubMed Central
Figure 3 A: Mortality by era (P = 0.49). B: Life-threatening events by era (P = 0.01). C: Incidence of any adverse event (AE) in year 1 of first infusion (P = 0.02 by era). D: CKD-EPI calculated glomerular filtration rate, by era.
Figure 3 A: Mortality by era (P = 0.49). B: Life-threatening events by era (P = 0.01). C: Incidence of any adverse event (AE) in year 1 of first infusion (P = 0.02 by era). D: CKD-EPI calculated glomerular filtration rate, by era.CC BY-NC-ND · PubMed Central

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Research works printed but not linked: 2

  1. Hering, 1999, Islet transplantation for patients with type 1 diabetes, Graft, 2, 12
  2. Rickels, 2011, Beta-cell secretory capacity after human islet transplantation by the CIT07 vs. Edmonton Protocol: preliminary results, Am J Transplant, 11, 79

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Metadata

Authors
Barton, F. B., Rickels, M. R., Alejandro, R., Hering, B. J., Wease, S., Naziruddin, B., Oberholzer, J., Odorico, J. S., Garfinkel, M. R., Levy, M., Pattou, F., Berney, T., Secchi, A., Messinger, S., Senior, P. A., Maffi, P., Posselt, A., Stock, P. G., Kaufman, D. B., Luo, X., Kandeel, F., Cagliero, E., Turgeon, N. A., Witkowski, P., Naji, A., O’Connell, P. J., Greenbaum, C., Kudva, Y. C., Brayman, K. L., Aull, M. J., Larsen, C., Kay, T. W. H., Fernandez, L. A., Vantyghem, M.-C., Bellin, M., & Shapiro, A. M. J.
Affiliations
  • Emmes (United States) (US)
  • University of Pennsylvania (US)
  • University of Miami (US)
  • University of Minnesota (US)
  • Baylor University Medical Center (US)
  • Department of Surgery, Division of Transplant Surgery, University of Illinois at Chicago, Chicago, Illinois
  • University of Wisconsin–Madison (US)
  • Southern Illinois University Carbondale (US)
  • The University of Texas Southwestern Medical Center (US)
  • Department of General and Endocrine Surgery, Lille University, Lille, France
  • University Hospital of Geneva (CH)
  • Vita-Salute San Raffaele University (IT)
  • University of Alberta (CA)
  • University of California, San Francisco (US)
  • Northwestern University (US)
  • City Of Hope National Medical Center (US)
  • Harvard University (US)
  • Emory University (US)
  • University of Chicago (US)
  • Westmead Hospital (AU)
  • Virginia Mason Medical Center (US)
  • Mayo Clinic (US)
  • University of Virginia (US)
  • Weill Cornell Medicine (US)
  • Department of Medicine, St. Vincent’s Institute, Fitzroy, Victoria, Australia
  • Université de Lille (FR)
Corresponding author
Barton, Franca B.
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2012-06-12
Volume
35
Issue
7
Pages
1436-1445
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc12-0063
PMC
PMC3379615
OpenAlex
W2040605985
Cited by
725
References
18
Citations by year
2026: 9 · 2025: 23 · 2024: 20 · 2023: 38 · 2022: 33 · 2021: 43 · 2020: 47 · 2019: 61 · 2018: 68 · 2017: 64 · 2016: 89 · 2015: 67 · 2014: 74 · 2013: 78 · 2012: 11
FWCI
74.91
Type
journal article
Language
en
Open access
Licence
cc-by-nc-nd
Locations
  • Diabetes Care (publishedVersion, cc-by-nc-nd)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Archive ouverte UNIGE (University of Geneva) (publishedVersion)
  • Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
  • eScholarship (California Digital Library) (submittedVersion)
  • eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
  • Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
  • Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
Funders
  • American Diabetes Association
  • Juvenile Diabetes Research Foundation United States of America
  • National Institutes of Health (UL1TR000150)
  • National Institute of Diabetes and Digestive and Kidney Diseases (K23DK084315)
  • National Center for Research Resources (UL1RR025741)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pancreatic function and diabetes
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
islet transplantation, type 1 diabetes, insulin independence, severe hypoglycemia, C-peptide, islet graft function, HbA1c, fasting blood glucose, adverse events
MeSH terms
Adolescent, Adult, Aged, Blood Glucose, C-Peptide, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Middle Aged, Registries, Islets of Langerhans Transplantation, Treatment Outcome

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