A Phase III trial funded by the National Institutes of Health found that quality of life for people with type I diabetes improved dramatically following transplantation of insulin-producing pancreatic islets, according to data published this week in the journal Diabetes Care.
The 48-patient trial involved participants with hypoglycemia unawareness, a condition that renders them unable to sense when their blood sugar drops to a dangerous level.
The study showed that people who received islets reported better overall health after the transplant, despite needing lifelong treatment with immune-suppressing drugs.
“Although insulin therapy is life-saving, Type I diabetes remains an extremely challenging condition to manage,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in prepared remarks. “For people unable to safely control Type I diabetes despite optimal medical management, islet transplantation offers hope for improving not only physical health but also overall quality of life.”
Pancreatic islets produce insulin, helping to control a person’s blood glucose levels. But in people with Type I diabetes, the immune system attacks these cells. Traditionally, people with Type I diabetes use insulin injections or pumps combined with glucose monitors to treat their condition. But insulin that is released naturally from the pancreas is better at controlling blood sugar than injected insulin, according to the NIH.
“People with Type I diabetes who are at high risk for hypoglycemic events have to practice caution every moment, even while sleeping. It is an exhausting endeavor that—like the events themselves—can keep them from living full lives,” Dr. Griffin Rodgers, director of the National Institute of Diabetes and Digestive and Kidney Diseases, added. “Although islet transplantation remains experimental, we are very encouraged by these findings, as we are by the rapid improvements in other treatments to help people with Type I diabetes monitor and manage their blood glucose, including artificial pancreas technology.”
All study participants received at least one islet transplant and just one year after their first procedure, 88% of the participants were free of severe hypoglycemic events, had restored awareness of hypoglycemia and had near-normal blood sugar control. Half of the group needed to continue taking insulin to control their blood glucose levels, the NIH team reported.
“This study was very rigorous both in terms of the number of measures used to assess quality of life and the number of evaluations performed,” paper co-author Dr. Nancy Bridges, chief of the transplantation branch at NIAID, said. “Islet transplant recipients not only reported a decrease in concerns and fears related to their diabetes, but also felt better overall, despite the need to take daily immunosuppressive drugs to prevent transplant rejection.”