New Research to Prevent Juvenile Diabetes

Oral insulin study hopes to prevent Type 1 diabetes in high-risk kids.


Nov. 12, 2007— -- When a child is diagnosed with juvenile diabetes, also known as Type 1 diabetes, the most serious form of the disease, routines and priorities change.

"From that moment on," said Ellen Gould, "it's part of every day." Gould, the mother of three children with juvenile diabetes, and her husband, Dave, said they were stunned when their first child was diagnosed with the disease.

"When Patrick was diagnosed, there was a real grieving period, a mourning period for us," said Dave Gould. "No child should ever have to live with this disease. It's an awful disease."

But the Goulds are past mourning now. The challenges are too real, and the need to keep up with all the tests, measurements and injections just too important to worry about feeling sorry about it, they said.

Patrick is 15. His brother Sam is 12. Their sister Sarah is 8. Every day, they each roll out the tiny packs they carry with them everywhere: needle sticks, blood sugar meters and injectable insulin. Their other siblings, who don't have diabetes, know the routine well and help their siblings prepare the shots and squeeze the blood and read the levels.

"What arm do you want to do?" Andrew asked his brother Sam.

Sam can't decide. They laugh. Finally, it's the left arm. They both count "Five seconds, one, two, three" as the insulin was delivered. Andrew spun around to play with his little sister, and Sam packed up his insulin needle.

To the outsider, it's not obvious that this is a family dealing with a life-threatening illness. The children play school sports, go on outings with friends, do chores and horseplay with the easy banter of siblings. And the family expresses hope.

"Great hope," said Ellen, looking toward her husband.

"Oh, yeah," he said. "I'm thoroughly convinced they will not have to live with this for the rest of their lives."

Medical science is moving so quickly and research advancing so rapidly, that Dave Gould believes there is strong reason to hope.

The Goulds are particularly optimistic about a groundbreaking national research study now under way that's focused on trying to stop Type 1 diabetes from developing in children. Children under the age of 5 are the group developing the disease the most rapidly.

"Every year, 13,000 new cases are diagnosed in the pediatric age group," said Dr. William Russell, director of pediatric endocrinology at Vanderbilt University. Russell and his staff are working with fellow researchers around the country on the project, which is known as the oral insulin study.

"We're using orally administered insulin to try to prevent the onset of diabetes in someone who is at high risk," Russell explained.

What they have found, through previous studies in mice, is that -- for reasons that have yet to be fully understood -- insulin taken in by the digestive tract seems to send out signals to the body that insulin is OK.

In a healthy body, that's not a concern, because insulin-producing cells are an important part of the mix, working in synch to regulate sugar in the blood.

But in a body with Type 1 diabetes, the immune system goes haywire, treating insulin-producing cells as invaders, attacking and destroying them. Without those insulin producers, the body has no way to keep sugar in the blood at a healthy level. It can become life-threatening.

But researchers don't want to give oral insulin to just anybody, not even to siblings of children with Type 1 diabetes, who are at greatest risk of developing the disease.

Rather, they are enlisting the aid of families who have children with Type-1 diabetes, asking them to have their healthy children tested for the presence of certain antibodies, antibodies that scientists believe are an early-warning sign that diabetes has at least a 50-50 chance of developing within a few years.

The Gould family took part in that testing. Oliver, age 3, they learned, has the antibodies. Dave Gould said it was some of the toughest news yet for their family to hear.

"I just can't imagine that we could end up with another child that would have a likelihood of getting this disease."

But they see a ray of hope in all of it. The oral insulin study is testing a new treatment in which tiny amounts of insulin are delivered in pill form in an effort to postpone the onset of diabetes in vulnerable children. Oliver now takes a pill every day. Russell said there should be virtually no side effects, because unlike injected insulin, it doesn't go straight into the bloodstream. "The insulin actually doesn't enter the body as intact insulin. It doesn't have any effect on the blood sugar levels. In previous studies, it's been shown to be a very safe and effective treatment."

There is, as often is the case in research studies, a catch. Scientists need a control group to compare the studied group against to gauge the effectiveness of oral insulin. So half the children in the study will receive an empty pill instead of the insulin. None of the families will know whether their child is receiving the oral insulin or an empty pill until the study is completed. And that could be at least six or seven years from now.

Dave and Ellen Gould accept that. Anything that helps researchers make progress against diabetes is worth trying, they said. "This is the part we can do. We can be involved in a research experiment, and there's really no risk to Oliver in doing this. And, hopefully, we can help blaze a path toward finding a cure.

To learn more about free screening for type 1 diabetes risk and studies, call 1-800-HALT-DM1 (1-800-425-8361) or visit

To see a list of clinics participating in the "Oral Insulin" study, visit

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