Clinical trial for newly diagnosed patients aims to save crucial beta cells
Eight-year-old Reid McCants doesn’t really seem to mind being in a hospital bed. He’s holding a stack of Pokémon cards in his left hand and clicking the TV remote in his right. When asked to show off the new hole in his smile where a tooth had been until a few days ago, he grins broadly.
But this Des Moines, Iowa, second-grader isn’t visiting University of Minnesota Amplatz Children’s Hospital for fun and games. Reid is enrolled in a TrialNet clinical study aimed at advancing type 1 diabetes research and helping kids like him beat the disease.
The road to a diagnosis
Reid was diagnosed with diabetes last September. His parents had begun to notice his low energy on the soccer field, his uncharacteristic irritability, and his tendency to get up at night to use the bathroom. But when his teacher called one day to mention his frequent urination, his mother, Shari, knew Reid needed to see his pediatrician right away.
At Reid’s doctor visit, his blood sugar registered 562; for a child, normal is 140 or lower. In mere minutes, Reid was diagnosed with diabetes and started insulin injections to bring his blood sugar back down. His dad, Matt, calls it “an intensive one-day lesson in what living with diabetes means.”
The McCants quickly became experts in how to manage this autoimmune disease but also came to understand that Reid was in a “honeymoon” phase, a relatively protected period during which the pancreas continues to work a bit before it completely gives out. Diabetes becomes more difficult to control and risk of complications worsens once the honeymoon phase ends.
When offered the chance for Reid to participate in a TrialNet clinical study that might extend that honeymoon stage, the family was intrigued. But it was Reid, they say, who made the final decision. “If we didn’t believe it was safe, we wouldn’t do it,” says Matt.
Prolonging the honeymoon
The University of Minnesota is a central participant in TrialNet, a global network of researchers focused on the prevention and early treatment of type 1 diabetes.
The four-year, double-blind TrialNet study in which Reid is participating specifically focuses on an anti-inflammatory drug called Canakinumab. Each patient enrolled in the study receives a monthly subcutaneous injection the first year, quarterly checkups the second year, and twice yearly visits the final two years.
Toni Moran, M.D., division head of pediatric endocrinology and diabetes, is the national leader of the Canakinumab study. She is one of TrialNet’s two University of Minnesota investigators, along with Brandon Nathan, M.D. She describes the autoimmune reaction researchers hope to halt with Canakinumab: When someone is diagnosed with diabetes, she says, the immune system is “going haywire.” The body no longer recognizes its own beta cells, which causes T cells to attack them. That leads to inflammation, which causes more T cells to strike and perpetuates the autoimmune reaction. Eventually, all beta cells are destroyed.
“Because this process takes time, there’s a period during which we can potentially intervene—when the attack is under way but before all beta cells are destroyed,” Moran explains. The clinical trial is testing to see whether Canakinumab can lessen inflammation, thereby saving beta cells.
Saving beta cells
“Our goal,” says Moran, “is to keep patients in a perpetual honeymoon stage where their own bodies are able to help make some of the needed insulin.” If successful, the drug could also be used as therapy for individuals with pretype 1 diabetes.
Additionally, by learning how to alter the immune response, the study could improve various transplant procedures, and its findings could potentially be applied to the treatment of other autoimmune diseases like lupus and Addison’s disease. “It has major implications,” says Moran.
For now, Reid faces regular insulin shots and blood sugar tests, but he’s still upbeat. “I can eat almost anything I want as long as I get insulin,” he says.
Meanwhile, his parents are hopeful. “We want to help others,” says Shari. “We were raised that way and would be so excited to be able to help another child.”
By Karin Miller
Read more about TrialNet.