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Oral insulin protects high risk children from type 1 diabetes in first study

Kathleen Blanchard's picture
Pilot study shows oral insulin safe and effective for preventing type 1 diabetes

New research funded by the Juvenile Diabetes Association found taking insulin by mouth helps boost immunity to prevent type 1 diabetes in children at high risk for the disease.


Results of a small pilot study published in the Journal of the American Medical Association (JAMA) is the first to show insulin provokes a protective immune response against type 1 diabetes. The finding could pave the way for development of a vaccine against the disease that is thought to be an autoimmune disorder that develops when the body mistakenly destroys beta cells in the pancreas that produce insulin.

Researchers are still uncertain how type 1 diabetes develops. Children with a family history of the condition are more susceptible. Some viruses have been implicated as a trigger for diabetes from antibodies that form to fight infection.

The study was conducted in four countries that included the U.S, Germany, Austria and the UK.

Insulin produces antibodies against type 1 diabetes

Georgeanna Klingensmith, MD, professor of pediatrics at the Barbara Davis Center for Diabetes (BDC) who led the research in the U.S. said the therapy produced immunity against type 1 diabetes among children studied. seem for the first time.

She adds the therapy appears to be safe and that none of the children developed low blood sugar, antibodies against insulin or diabetes.

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The study

Ezio Bonifacio, PhD, of the DFG Center for Regenerative Therapies, Technische Universität Dresden, Germany led the study.

Researchers enrolled children age 2 to 7 who were either given oral insulin or placebo daily for three to 18 months. Three different doses of insulin were used - 2.5mg, 7.5mg and 67.5 mg.

Higher doses of oral insulin produced the strongest immune response - 83.3 percent of the children given 67.5 mg of the therapy developed immunity against type 1 diabetes compared to 33 percent given 7.5 mg and 16.7 percent of children who received 2.5 mg. Only two our of 10 children given placebo developed any sort of immunity.

"This is the first time we have seen a healthful immune response from any therapy used in children who are at a high risk of type 1 diabetes," Klingensmith said. The finding paves the way for larger clinical trials in hopes of developing a vaccine that could prevent type 1 diabetes.


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Great news for me.