New clinical trial results show that transplantation of pancreatic islets — cell clusters that contain insulin-producing cells — prevents severe, potentially life-threatening drops in blood sugar in people with type 1 diabetes. Researchers found that the treatment was effective for people who experienced episodes of severe hypoglycemia — low blood sugar levels that can lead to seizures, loss of consciousness and death — despite receiving expert care.
The Clinical Trials Statistical and Data Management Center (CTSDMC), based in the University of Iowa College of Public Health, was the data coordinating center for this national study. UI authors on the study are Dr. William Clarke (professor emeritus) and the late Dr. Kathryn Chaloner, former professor and head of the UI’s department of biostatistics.
The Phase 3 trial was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both part of the National Institutes of Health, and was conducted by the NIH-sponsored Clinical Islet Transplantation (CIT) Consortium. The investigators designed the study in consultation with the U.S. Food and Drug Administration to enable potential future licensure of the manufacture of purified human pancreatic islets. The results appear online in Diabetes Care
“The findings suggest that for people who continue to have life-altering severe hypoglycemia despite optimal medical management, islet transplantation offers a potentially lifesaving treatment that in the majority of cases eliminates severe hypoglycemic events while conferring excellent control of blood sugar,” said NIAID director Dr. Anthony S. Fauci.