MedicalResearch.com Interview with:
Dr. Rodolfo Alejandro, MD
Professor of Medicine
University of Miami Miller School of Medicine
Co-Director of the Cell Transplant Center
Director/Attending Physician of the Clinical Cell Transplant Program
Diabetes Research Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In type 1 diabetes, the insulin-producing islets cells of the pancreas have been mistakenly destroyed by the immune system, requiring patients to manage their blood sugar levels through a daily regimen of insulin therapy. Islet transplantation has allowed some patients to live without the need for insulin injections after receiving a transplant of donor cells. Some patients who have received islet transplants have been insulin independent for more than a decade, as DRI researchers have published. Currently, islet transplantation remains an experimental procedure limited to a select group of adult patients with type 1 diabetes.Although not all subjects remain insulin independent, like the subjects described in this presentation, after an islet transplant a significant number of them continue with excellent graft function for over 10 years that allows them to have near-normal glucose metabolism in the absence of severe hypoglycemia on small doses of insulin.
In 2016, the National Institutes of Health-sponsored Clinical Islet Transplantation Consortium reported results from its Food and Drug Administration (FDA)-authorized Phase 3 multi-center trial, of which the DRI was a part, indicating that islet transplantation was effective in preventing severe hypoglycemia (low blood sugar levels), a particularly feared complication in type 1 diabetes that can lead to seizures, loss of consciousness and even death.
The study was a significant step toward making islet transplantation an approved treatment for people with type 1 diabetes and reimbursable through health insurance, as it is in several other countries around the world.
MedicalResearch.com: What should readers take away from your report?
Response: The CGM data we have obtained from our islet transplant patients clearly demonstrates that islet transplantation can result in glucose levels that are close to those in people who do not have type 1 diabetes, even 10 years or more after undergoing the cell-replacement procedure. This report confirms the superiority of transplantation of insulin-producing cells compared to insulin therapy, with glucose control results that were even better than the goals of CGM in hybrid closed-loop systems. Hopefully, this will be of assistance in bringing islet transplantation closer to FDA approval, allowing the treatment to be made available to U.S. patients, as has already been the case in several other countries, for many years
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We are carefully evaluating factors ( metabolic, immunological, demographic) in these subjects that have allowed for them to remain insulin independent for over 10 years. We then can apply what we learn to future transplants.
Citation: ADA 2019 abstract
Continuous Glucose Monitoring Metrics in Islet Transplant Recipients with Long-Term Insulin Independence David A. Baidal, Ana M Alvarez, Nathalia Padilla, Camillo Ricordi, and Rodolfo Alejandro
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