Daily Oral Insulin

A vaccine to prevent type 1 diabetes could be on the horizon.

A new study in the Journal of the American Medical Association (JAMA) indicates that children taking oral insulin on a daily basis can develop protective immune responses that may thwart type 1 diabetes.

Normally, the immune system produces a protective response that prevents the body from destroying its own cells. In children with type 1 diabetes, their immune systems destroy the pancreatic cells that produce insulin.

Ezio Bonifacio, Ph.D., from the DFG Center for Regenerative Therapies in Dresden, Germany, led the study. He worked with colleagues to see if they could coax the body into generating the protective responses that would prevent the disease.

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Small Study, Big Results

The researchers looked at children between the ages of 2 and 7 who had a strong family history of type 1 diabetes.

The study was performed from 2009 to 2013 in Germany, Austria, the United Kingdom, and the United States.

When the children were given increasing doses of insulin in their food every day for an average of six months, the children showed an immune response that could protect them from the disease.

In the study, 15 children received various doses of oral insulin and 10 were on a placebo. The treatment lasted from 3 to 18 months, depending on the child.

“This is the first time we are seeing any sort of response by the immune system to orally administered insulin in children,” said Bonifacio.

He noted there were not any unwanted side effects.


“Feeding insulin to children who have a high genetic risk for starting the process that eventually leads to type 1 diabetes can actually have a vaccine-like effect that tickles the immune system of these children in a way that we think is protecting them from getting type 1 diabetes,” Bonifacio said.

To determine who needs the insulin, Bonifacio said children can undergo a blood test. With the study participants, researchers gave children the insulin before signs of the disease began to show. He said many children who develop the disease do so from about 6 months old to 2 to 3 years old.

“To prevent it, we need to start treating around 6 months,” he said.

Bonifacio said children would have to be treated until they reach 2 or 3 years of age, when the period of increased risk is over.

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Coaxing the Immune System

Bonifacio said the notion of giving children insulin may sound counterintuitive because type 1 diabetes starts with the child's immune system responding to its own insulin.

“We think that the reason that some of the genetically at-risk children start the disease process do so because their immune system didn’t see enough insulin early enough and in the wrong place,” he said. “Oral exposure at the right doses is known to teach the immune system to make protective responses.”

Bonifacio added the mechanism can generally be replicated in mice. Researchers are starting to learn how to do the same thing with allergens.

“This is a significant finding, and given JDRF’s mission to achieve a world without type 1 diabetes, these study results are exciting and bring us one step closer to the potential of seeing an oral vaccination strategy to prevent type 1 diabetes,” Julia Greenstein, vice president of discovery research at the Juvenile Diabetes Research Foundation (JDRF), said in a statement.

The JDRF helped to fund the study.

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Looking Ahead

The researchers plan to keep testing this model in a larger group of children. Eventually, they hope to study whether the response from giving children insulin orally can prevent type 1 diabetes.

Dr. Molly Regelmann, a pediatric endocrinologist at the Kravis Children’s Hospital at Mount Sinai in New York City, said the study shows promise.

“In order to determine whether daily oral insulin actually translates to a decrease in type 1 diabetes incidence, a much larger high-risk population needs to be given the oral insulin and monitored for immune response over years,” she said.

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