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More patients than anticipated PLEDGE to fight diabetes

In the past year, over 2,000 patients helped to fight type 1 diabetes.
Sanford Health was initially hoping for 1,000.
A year ago, the health care provider announced the PLEDGE pediatric screening study. The study is an effort to help identify, and potentially predict, children who could develop type 1 diabetes and celiac disease.
Kurt Griffin, PhD, M.D., a Sanford Health pediatric endocrinologist and director of clinical trials for the Sanford Project, said the study could be instrumental in early detection of the diseases, before problems arise.
“Type 1 diabetes is an autoimmune disease. Your immune system, instead of just keeping healthy, is attacking the part of the pancreas that makes insulin. That’s something that probably goes on for a long time before someone comes in, and is actually sick,” he explained.
“Our goal is, ‘how do we figure out who’s on that path?’” he added.
And they’ve had more help figuring that out than they could’ve asked for.
Griffin said the initial goal was recruitment of 1,000 kids in the first year.
“We thought we were aiming pretty high. As we’re just past a year, we already have 2,200 enrolled. We initially said we would start out in Sioux Falls, and (move to) Fargo by the end of the second year. Well, we did that in the first five months. We are now in 42 clinics.
“Our goal is to be open in every clinic in our footprint that sees children by the end of this year,” he said.
Dr. Griffin said one of the reasons the study may have become so popular is because it’s a user-friendly process, building on Sanford Health’s existing resources.
“We’re trying to leverage the infrastructure we already have. We already have a lot of patients that come in for routine care. We have one medical record system across our entire system, which has a component called MyChart, that we use to communicate with families in a secure way,” he said.
The consent forms are even done through MyChart, making it an easy process for patients, he added.
Emalee Farley, mother of eight-month-old PLEDGE study participant Franklin Farley, said it truly was a seamless process.
“Initially, I saw it on his (Franklin’s) MyChart. I kind of ignored it right away to be completely honest,” she laughed. “Then, my husband, who works at Sanford, had told me a little bit more about it and upon discussing it, of course we want him to be a part of this. It’s incredible what they’re (Sanford) doing,” she added.
Listen: Ep. 12: Research screening works to end type 1 diabetes
She said the reason she and her husband Fletcher enrolled their son has a lot to do with the COVID-19 pandemic.
“We just wanted to do everything we could to be involved with his health, and thinking about longterm, what we could do to prevent him from getting sick with anything. Especially with him being born during COVID, I feel like we were a lot more thoughtful about his health, and the things we can do to protect him,” she said.
Farley said after being enrolled, a small blood donation, done through a finger prick, is taken.
And that’s all you have to do.
“Long term, it’s an easy thing you can do to look out for your child,” she said.
When asked how the study grows from here, Dr. Griffin said expanding the study to more clinics is “only the start.” He said the next step would be to demonstrate that this screening improves outcomes, and that is should become a standard of care.
“That means really getting more and more kids actually signed up, and samples collected and followed over time. Again, the goal of this is to demonstrate that this will be a good thing for our patients in the long run.
“I’ve talked with providers in different clinics across Sanford. Almost invariably, there’s somebody who said they just had a child come in, and by the time they came in, they were already in diabetic ketoacidosis and had to be airlifted. If we could catch them earlier and avoid this, this is absolutely worth doing,” he said.

Posted In Children’s, Research

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