The first international, multicenter trial of the Edmonton Protocol — a standardized approach to the transplantation of insulin-producing islets — demonstrates that this may be an appropriate therapy that can dramatically benefit certain patients with severe complications of Type 1 diabetes mellitus.
As described in the September 28, 2006 issue of The New England Journal of Medicine, 36 adult volunteers at nine clinical trial sites in North America and Europe received up to three infusions of islets, which are non-functioning in people with Type 1 diabetes. The trial was designed to gauge how well the transplanted islets would function in regulating blood sugar levels.
A year after the final treatment, 44 percent of the transplant recipients no longer needed insulin injections, and an additional 28 percent had partial islet function, which was associated with resolution of hypoglycemic unawareness — a severe complication of diabetes in which people can no longer recognize early symptoms of low blood sugar. Insulin independence did not persist indefinitely in most cases, and less than a third of the people who had been freed from insulin after one year remained so by two years. However, individuals with functioning islets had improved control of their diabetes, even though they still needed to take insulin shots. Further research will be needed to improve and prolong the beneficial effects of the procedure, the researchers say.
Jason Socrates Bardi
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