Courtney Collen (Host): Hello, welcome to Her Kind of Healthy, our health podcast series brought to you by Sanford Health. I’m your host Courtney Collen with Sanford Health News. This series is starting brand new, honest conversations about self-care, healthy living and so much more today.
We’re talking about the new PLEDGE study through Sanford Research, which is a really unique opportunity to identify and predict which children may be at risk of developing autoimmune diseases, like type 1 diabetes and celiac disease. I have the pleasure of sitting down with two Sanford Health providers to tell us more about PLEDGE and advancing science through autoimmune diseases. Dr. Kurt Griffin, a pediatric endocrinologist, is leading the PLEDGE study. We also have Dr. Laura Whittington, a pediatrician with Sanford Children’s, here to explain why this opportunity is so important and answer some of those more commonly asked questions. Thank you both so much for being here.
Dr. Kurt Griffin: Thank you for having us.
Courtney Collen (Host): Dr. Griffin, we’ll begin with you. Tell us what this PLEDGE research study is.
Dr. Kurt Griffin: My area that I focus on for research is type 1 diabetes. And at its heart, this is an autoimmune disease where the immune system that’s supposed to keep us healthy is instead attacking those cells that make insulin. This is something that usually by the time we know somebody has it it’s full-blown and we can treat it with insulin, but we’re not actually taking care of anything with the underlying process, at least to it. One of the things that we’re really working on is how do we figure out who’s on that path to getting type 1 diabetes? And how do we intervene earlier? And there’s an international group called diabetes. Trialnet who has been looking at this and screening family members of people with type 1 diabetes. And that’s where we’ve started to see some progress on, you know, there’s actually one study where we can actually show, we can slow it down a little bit, you know, by an average of two years of somebody getting it.
So that’s the first time that we’re actually starting to get some traction on this. The problem is if we’re looking just at family members of people who already have it, we’re missing more than 90% of the people that are going to get it eventually. So the problem is how do we spread it so that we can start looking more broadly? And this is something where it’s a great fit with Sanford Sanford as this large multi-state nonprofit organization that provides a lot of health care and also has an interest in fighting type 1 diabetes. This is a great match. And the goal here is how do we start to look at some of this screening and bake it into routine care and not just show that we can do it, but also measure outcomes from that that are financial, how much does it cost, but also how much is it saving down the road? And, you know, that’s something where we also have a population health research group. That’s very, has some very sophisticated modeling to help with that, with the goal of eventually showing this will actually pay for itself. And it’s worth implementing, not just here, but eventually this should be standard of care.
Courtney Collen (Host): Why these two diseases, type 1 diabetes and celiac together?
Dr. Kurt Griffin: Great way to put it because they, sometimes they oftentimes come together. And if you look at the kids who have type 1 diabetes, so they have an increased risk of having autoimmune thyroid disease, which, you know, we screen for as well, but also celiac disease. And some of that has to do with some of the genetics that kind of follow between the two of them. Celiac disease is also one of those where, you know, there’s a lot of awareness of that in the community. And a lot of questions about who may or may not actually have gluten sensitivity. And this is a question a lot of families kind of have anyway. So that’s kind of value added as long as we’re taking a sample. It turns out that the way we’re doing it, it’s just not costing us any more to provide this information. And it’s something that families and other places have found valuable.
Courtney Collen (Host): What exactly is this study collecting?
Dr. Kurt Griffin: So we’re collecting little bit of information, including, you know, who else in the family may already have diabetes in terms of physically collecting, we’re taking just a little bit of blood and at entry into the study, we take just literally a blood spot, which could even be incorporate into the newborn screen that every new baby gets, and then kind of around the two year well-child visit or around the pre-kindergarten visit. We’re trying to bake into that, collecting another sample for what we call auto antibodies. So markers at the body starting to attack the pancreas. So the sample for the auto antibodies, one of the things that has opened the doors to us, being able to do this now is not only have we a partner where we can get this done for, you know, very inexpensive cost to, to run the sample, but we can do on a very small volume. So rather than taking a whole big tube of blood, that may be a couple of tablespoons. We can do this on a finger stick and take a couple of drops, or we can take, you know, if you prefer a little bit of blood from a vein and particularly if a child’s already getting blood drawn is just one more small, very small tube that gets added onto that without even an additional poke.
Courtney Collen (Host): So it’s a very easy process.
Dr. Kurt Griffin: We’re actually trying to make it as easy as possible. And as I said, if we can piggyback on labs that are already being drawn so much the better we’re trying to make it as easy as possible for families to enroll in this. This is one things that, again, Sanford is really pushing the envelope on how this is being done by baking into routine care. Traditionally, there have been a few other places that have tried to do broader screening of the general population. And the way that usually works is you have a clinical research coordinator who’s specifically just for the study and he park him or her in a clinic or an emergency department. And every kid that comes in you offer. And then we go through the whole consent process and it’s fairly labor-intensive per specimen that he gets her per person, that he would enroll here.
Dr. Kurt Griffin: We’re actually leveraging the whole Epic, my chart that a lot of families are already using to communicate with the electronically and securely. So that that consent process actually gets presented to them there. And they can go through that. And as long as they don’t have questions that they need answered, they can actually do the consent themselves right there. That’s being again automated in a way where if we know someone’s coming in for well-child visit at the right window coming up in the next couple of weeks, we can send a message automatically to them. So they have time to look at it. They have time even to call us and we can answer any questions they have. And then the orders are already in the system so that when they’re here, they have their visit, they go to the lab and whatever labs they need for the study or outside the study get taken care of. And they go home easy. We try to make it as easy as possible for everybody. Yeah.
Courtney Collen (Host): It sounds like it. Who is eligible to participate? We’re talking about young children. So tell us who exactly what age range can participate in this, in this blood sample, in this study.
Dr. Kurt Griffin: Right, right now we’re taking any child up to age six. So up until their sixth birthday, where you welcomed to kind of join in and then includes even, you know newborns. We can we’re again, trying to demonstrate that we can collect that little blood spot right at the same time that they’re collecting the other spots for the newborn screen. So again, it’s not another probe, it’s not a volume of blood that’s going to cause any sort of problem to anybody. So from birth all the way up to their sixth birthday,
Courtney Collen (Host): And if a parent wants to enroll their child, how do they do that?
Dr. Kurt Griffin: There are really kind of two answers to that right now. We’re still in the process of ramping this up and the parents are coming to the clinics that are already open. We’ll be getting a message automatically. If it’s a scheduled visit, if it’s something that’s more of a sick visit, we can still do it then. And a lot of the providers are able to explain a little bit about what the study is. And if parents are interested in the clinic, there’s actually a way where they can sign up, right. Then they still have to go through the electronic consent process and be sure that all that’s taken care of before we collect a research sample, but that can all be done right on the spot. As we get to the point where we have enough clinics open, where we were essentially doing it across our whole footprint, which that’s our goal, that’s the point where we’ll actually have a lot more information up on a website that’s open to the general public and people would be able just to click there and it would take them right to where we do the automatic consent.
Shouldn’t, it’ll take them right to where they do the consent online and it’s filed away. And then the next time they come in, we just get the sample. And off we go.
Courtney Collen (Host): I want to bring in Dr. Laura Whittington, who is a pediatrician here at Sanford Children’s at the clinic at 69th and Louise. And thank you again for being with us. Why are you recommending this study to your patients and how do you do that? Like, what does the conversation look like?
Dr. Laura Whittington: Being a general pediatrician, a lot of our job is preventive care. We want to try to prevent these diseases in children before we have an issue. And the same goes for type 1 diabetes. If there is a way to know who is at risk, these children, we can monitor them more closely and try to one, prevent them from developing it, or maybe catch it earlier so that we don’t end up with them having to stay in the hospital while we try to get them under control so they can go back home.
So as far as general pediatrics, it’s very easy to have that conversation with parents. It goes right along with all of their other anticipatory guidance that we normally do at a well visit. We talk about how children and adults are at a risk for developing diabetes. And if we just screened those families, where there was a family history of diabetes, we would miss a lot of patients and most families when they hear this, they are ready to enroll in this study.
Courtney Collen (Host): Thank you both so much for being here. I look forward to learning more about how the PLEDGE study will advance research in autoimmune diseases, especially as it relates to our children. We appreciate your time.