Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network
Open Access
- 11 June 2015
- journal article
- clinical trial
- Published by American Diabetes Association in Diabetes Care
- Vol. 38 (9), 1714-1722
- https://doi.org/10.2337/dc15-0094
Abstract
OBJECTIVE: To describe the 5-year outcomes of islet transplantation within the Swiss-French GRAGIL Network. RESEARCH DESIGN AND 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.Keywords
Funding Information
- Aide aux Jeunes Diabétiques AJD
- Agir pour les Maladies Chroniques
- French Ministry of Health
- Association Francaise des Diabetiques
- Swiss National Foundation for Scientific Research (3200B0-102134)
This publication has 35 references indexed in Scilit:
- Increased Mortality of Patients With Diabetes Reporting Severe HypoglycemiaDiabetes Care, 2012
- Potent Induction Immunotherapy Promotes Long-Term Insulin Independence After Islet Transplantation in Type 1 DiabetesAmerican Journal of Transplantation, 2012
- Portal Vein Thrombosis Is a Potentially Preventable Complication in Clinical Islet TransplantationAmerican Journal of Transplantation, 2011
- Primary Graft Function, Metabolic Control, and Graft Survival After Islet TransplantationDiabetes Care, 2009
- Quality of life after islet transplantation: data from the GRAGIL 1 and 2 trialsDiabetic Medicine, 2009
- Restoration of Hypoglycemia Awareness After Islet TransplantationDiabetes Care, 2008
- Transplant Estimated FunctionDiabetes Care, 2008
- One More Step Along the RoadTransplantation, 2007
- Sequential Kidney/Islet Transplantation: Efficacy and Safety Assessment of a Steroid-Free Immunosuppression ProtocolAmerican Journal of Transplantation, 2006
- Islet Transplantation Is Associated with Improvement of Renal Function among Uremic Patients with Type I Diabetes Mellitus and Kidney TransplantsJournal of the American Society of Nephrology, 2003