title: Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network.
abstract: OBJECTIVE
  To describe the 5-year outcomes of islet transplantation within the Swiss-French GRAGIL Network.
  
  
  METHODS
  Retrospective analysis of all subjects enrolled in the GRAGIL-1c and GRAGIL-2 islet transplantation trials. Parameters related to metabolic control, graft function, and safety outcomes were studied.
  
  
  RESULTS
  Forty-four patients received islet transplantation (islet transplantation alone [ITA] 24 patients [54.5%], islet after kidney [IAK] transplantation 20 patients [45.5%]) between September 2003 and April 2010. Recipients received a total islet mass of 9,715.75 ± 3,444.40 IEQ/kg. Thirty-four patients completed a 5-year follow-up, and 10 patients completed a 4-year follow-up. At 1, 4, and 5 years after islet transplantation, respectively, 83%, 67%, and 58% of the ITA recipients and 80%, 70%, and 60% of the IAK transplant recipients reached HbA1c under 7% (53 mmol/mol) and were free of severe hypoglycemia, while none of the ITA recipients and only 10% of the IAK transplant recipients met this composite criterion at the preinfusion stage. Thirty-three of 44 patients (75%) experienced insulin independence during the entire follow-up period, with a median duration of insulin independence of 19.25 months (interquartile range 2-58). Twenty-nine of 44 recipients (66%) exhibited at least one adverse event; 18 of 55 adverse events (33%) were possibly related to immunosuppression; and complications related to the islet infusion (n = 84) occurred in 10 recipients (11.9%).
  
  
  CONCLUSIONS
  In a large cohort with a 5-year follow-up and in a multicenter network setting, islet transplantation was safe and efficient in restoring good and lasting glycemic control and preventing severe hypoglycemia in patients with type 1 diabetes.
authors.affiliation: Department of Endocrinology, Pôle DigiDune, Grenoble University Hospital, Joseph Fourier University, Grenoble, France slablanche@chu-grenoble.fr.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Lablanche
authors.affiliation: Centre Hospitalier Universitaire Jean Minjoz, Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition, Besançon, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Borot
authors.affiliation: Centre Hospitalier de Montpellier, Pôle Rein Hypertension Métabolisme, Service d'Endocrinologie, Montpellier, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Wojtusciszyn
authors.affiliation: Department of Nephrology, Pôle DigiDune, Grenoble University Hospital, Joseph Fourier University, Grenoble, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Bayle
authors.affiliation: Department of Nephrology, Pôle DigiDune, Grenoble University Hospital, Joseph Fourier University, Grenoble, France.
authors.forename: Rachel
authors.initials: R
authors.lastname: Tétaz
authors.affiliation: Hospices Civils de Lyon, Service d'Urologie et de Chirurgie de la Transplantation, Pôle Chirurgie, Lyon, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Badet
authors.affiliation: Hospices Civils de Lyon, Service d'Endocrinologie Diabète Nutrition, Lyon, France.
authors.forename: Charles
authors.initials: C
authors.lastname: Thivolet
authors.affiliation: Hospices Civils de Lyon, Service de Néphrologie Médecine de la Transplantation et Immunologie Clinique, Lyon, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Morelon
authors.affiliation: Centre Hospitalier Universitaire de Nancy, Service de Néphrologie, Nancy, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Frimat
authors.affiliation: Service d'Endocrinologie, Diabétologie et Maladies Métaboliques, Centre Hospitalier Sud-Francilien, Corbeil-Essonnes, France.
authors.forename: Alfred
authors.initials: A
authors.lastname: Penfornis
authors.affiliation: Hôpitaux Universitaires de Strasbourg, Service d'Endocrinologie Diabète et Maladies Métaboliques, Pôle NUDE, Strasbourg, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Kessler
authors.affiliation: Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, and Université de Lyon, EA Santé-Individu-Société 4129, Lyon, France.
authors.forename: Coralie
authors.initials: C
authors.lastname: Brault
authors.affiliation: Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, and Université de Lyon, EA Santé-Individu-Société 4129, Lyon, France.
authors.forename: Cyrille
authors.initials: C
authors.lastname: Colin
authors.affiliation: CHU de Clermont-Ferrand, Service Endocrinologie-Diabète-Maladies Métaboliques, Clermont Ferrand Université, Clermont-Ferrand, France.
authors.forename: Igor
authors.initials: I
authors.lastname: Tauveron
authors.affiliation: Departement of Surgery, Islet Isolation, and Transplantation Center, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Domenico
authors.initials: D
authors.lastname: Bosco
authors.affiliation: Departement of Surgery, Islet Isolation, and Transplantation Center, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Thierry
authors.initials: T
authors.lastname: Berney
authors.affiliation: Department of Endocrinology, Pôle DigiDune, Grenoble University Hospital, Joseph Fourier University, Grenoble, France.
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Benhamou
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000378:metabolism* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D016381:Islets of Langerhans Transplantation / Q000379:methods*; D016030:Kidney Transplantation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012449:Safety; D013557:Switzerland; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose