Islet Transplantation Improves Peripheral Neuropathy in Patients With Type 1 Diabetes: A 5 Year Prospective Study

Objective: Long-term benefit-risk ratio of islet transplantation remains unclear. We explored the evolution of peripheral and autonomic neuropathy during 5 years after islet transplantation with the Edmonton protocol in type 1 diabetic patients. Patients and Methods: Twenty-one patients (13 islet-alone and 8 islet-after-kidney) were enrolled in this prospective cohort study. Islet transplantation consisted of 2 or 3 sequential infusions with IL2rAb / sirolimus - tacrolimus immunosuppression. All patients underwent biological evaluation, continuous blood pressure and continuous glucose monitoring (CGM), lower -limb electrophysiological testing and cardiovascular autonomic testing (R-R variation with paced breathing, Valsalva ratio, postural heart rate and blood pressure changes) before transplantation and yearly during 5 years. Outcomes were analyzed in intention to treat. Results: At 5 years, islet remained functional in 18 patients (85%). Ten patients (48%) were insulin-independent with a median (IQR) HbA1c at 6.0 (5.86.7) % vs. 7.8 (6.9-8.3) 96 in those requiring insulin (p