Ten-Year Outcome of Islet Alone or Islet After Kidney Transplantation in Type 1 Diabetes: A Prospective Parallel-Arm Cohort Study (original) (raw)
Clinical Care/Education/Nutrition/Psychosocial Research| October 10 2019
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Marie-Christine Vantyghem
1University of Lille, U1190-EGID, Lille, France
2Department of Endocrinology, Diabetology, and Metabolism, Centre Hospitalier Universitaire de Lille, Lille, France
3Inserm, U1190, Lille, France
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1University of Lille, U1190-EGID, Lille, France
3Inserm, U1190, Lille, France
4Department of General and Endocrine Surgery, Centre Hospitalier Universitaire de Lille, Lille, France
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1University of Lille, U1190-EGID, Lille, France
3Inserm, U1190, Lille, France
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2Department of Endocrinology, Diabetology, and Metabolism, Centre Hospitalier Universitaire de Lille, Lille, France
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2Department of Endocrinology, Diabetology, and Metabolism, Centre Hospitalier Universitaire de Lille, Lille, France
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2Department of Endocrinology, Diabetology, and Metabolism, Centre Hospitalier Universitaire de Lille, Lille, France
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1University of Lille, U1190-EGID, Lille, France
3Inserm, U1190, Lille, France
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1University of Lille, U1190-EGID, Lille, France
3Inserm, U1190, Lille, France
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5Department of Methodology, Biostatistics, and Data Management, Centre Hospitalier Universitaire de Lille, Lille, France
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1University of Lille, U1190-EGID, Lille, France
3Inserm, U1190, Lille, France
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6Department of Nephrology, Centre Hospitalier Universitaire de Lille, Lille, France
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7Department of Cardiology, Centre Hospitalier Universitaire de Lille, Lille, France
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6Department of Nephrology, Centre Hospitalier Universitaire de Lille, Lille, France
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8Department of Biochemistry and Hormonology, Centre Hospitalier Universitaire de Lille, Lille, France
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6Department of Nephrology, Centre Hospitalier Universitaire de Lille, Lille, France
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1University of Lille, U1190-EGID, Lille, France
3Inserm, U1190, Lille, France
4Department of General and Endocrine Surgery, Centre Hospitalier Universitaire de Lille, Lille, France
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1University of Lille, U1190-EGID, Lille, France
3Inserm, U1190, Lille, France
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1University of Lille, U1190-EGID, Lille, France
3Inserm, U1190, Lille, France
4Department of General and Endocrine Surgery, Centre Hospitalier Universitaire de Lille, Lille, France
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A complete list of the members of the working groups Diaménord, G4, and Platform of Biotherapy appears in the Supplementary Data online.
Diabetes Care 2019;42(11):2042–2049
Citation
Marie-Christine Vantyghem, Mikael Chetboun, Valéry Gmyr, Arnaud Jannin, Stéphanie Espiard, Kristell Le Mapihan, Violeta Raverdy, Nathalie Delalleau, François Machuron, Thomas Hubert, Marie Frimat, Eric Van Belle, Marc Hazzan, Pascal Pigny, Christian Noel, Robert Caiazzo, Julie Kerr-Conte, François Pattou, on behalf of the working groups Diaménord, G4, and Platform of Biotherapy; Ten-Year Outcome of Islet Alone or Islet After Kidney Transplantation in Type 1 Diabetes: A Prospective Parallel-Arm Cohort Study. _Diabetes Care 1 November 2019; 42 (11): 2042–2049. https://doi.org/10.2337/dc19-0401
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OBJECTIVE
The long-term outcome of allogenic islet transplantation is unknown. The aim of this study was to evaluate the 10-year outcome of islet transplantation in patients with type 1 diabetes and hypoglycemia unawareness and/or a functioning kidney graft.
RESEARCH DESIGN AND METHODS
We enrolled in this prospective parallel-arm cohort study 28 subjects with type 1 diabetes who received islet transplantation either alone (ITA) or after a kidney graft (IAK). Islet transplantation consisted of two or three intraportal infusions of allogenic islets administered within (median [interquartile range]) 68 days (43–92). Immunosuppression was induced with interleukin-2 receptor antibodies and maintained with sirolimus and tacrolimus. The primary outcome was insulin independence with A1C ≤6.5% (48 mmol/mol). Secondary outcomes were patient and graft survival, severe hypoglycemic events (SHEs), metabolic control, and renal function.
RESULTS
The primary outcome was met by (Kaplan-Meier estimates [95% CI]) 39% (22–57) and 28% (13–45) of patients 5 and 10 years after islet transplantation, respectively. Graft function persisted in 82% (62–92) and 78% (57–89) of case subjects after 5 and 10 years, respectively, and was associated with improved glucose control, reduced need for exogenous insulin, and a marked decrease of SHEs. ITA and IAK had similar outcomes. Primary graft function, evaluated 1 month after the last islet infusion, was significantly associated with the duration of graft function and insulin independence.
CONCLUSIONS
Islet transplantation with the Edmonton protocol can provide 10-year markedly improved metabolic control without SHEs in three-quarters of patients with type 1 diabetes, kidney transplanted or not.
Clinical trial reg. nos. NCT01123187 and NCT00446264, clinicaltrials.gov
M.-C.V. and M.C. contributed equally to this work.
© 2019 by the American Diabetes Association.
2019
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