Islet transplantation offers the potential to improve glycemic control in a subgroup of patients with type 1 diabetes mellitus with refractory hypoglycemia.
Dr James Shapiro and colleagues conducted a multicenter trial to explore the feasibility of islet transplants using a common protocol, known as the Edmonton protocol.
The research team enrolled 36 subjects with type 1 diabetes mellitus, who underwent islet transplantation at 9 international sites.
Islets were prepared from pancreases of deceased donors and were transplanted within 2 hours after purification, without culture.
|58% attained insulin independence|
|New England Journal of Medicine|
The primary end point was defined as insulin independence with adequate glycemic control 1 year after the final transplantation.
The team found that 44% met the primary end point, and 28% had partial function 1 year after the final transplant.
A further 28% had complete graft loss 1 year after the final transplantation.
The researchers found that 58% of subjects attained insulin independence with good glycemic control at any point throughout the trial.
Of these subjects, 76% required insulin again at 2 years.
Only 31% of the subjects who reached the primary end point remained insulin-independent at 2 years.
Dr Shapiro's team concludes, “Islet transplantation with the use of the Edmonton protocol can successfully restore long-term endogenous insulin production and glycemic stability in subjects with type 1 diabetes mellitus and unstable control.”
“However, insulin independence is usually not sustainable.”
“Persistent islet function even without insulin independence provides both protection from severe hypoglycemia and improved levels of glycated hemoglobin.”