Ep. 12 - The ENDIA Study - 10 years in!

What causes Type 1 Diabetes? The Environmental Determinants of Islet Autoimmunity (ENDIA) Study aims to find the cause(s) of type 1 diabetes to inform ways to prevent it. A long-term study with some results shared by Kelly who is the ENDIA coordinator, 10 years in. The exciting news is… the study has also received funding to keep doing the essential research around T1D and some possible environmental causes. Finding links to the causes of islet cell autoimmunity may well hold the key to treatments and prevention in the future.

Jaimee’s eldest son  has been in this study since he was in the womb. The cord blood from pregnancy was even collected. This study is one of a kind! Listen in and please rate us on your fave podcast app… and share to help this information reach more people.

Link to ENDIA website and further information:
https://www.endia.org.au/
https://www.endia.org.au/publications/

Video updates
ENDIA Study (vimeo.com)

Type 1 Diabetes Immunotherapy Trials
ATIC (svi.edu.au)

Teplizumab: new drug to delay the onset of Type 1 Diabetes
Teplizumab (Tzield): A new drug to delay the onset of type 1 diabetes is approved in the US - Diabetes Australia

You can follow on Instagram @endiastudy
https://instagram.com/endiastudy?igshid=YmMyMTA2M2Y=

Transcript

Jaimee 0:22

All right, everybody. Welcome back to another episode of Diabetes in the Raw Today. We're excited. We have a special guest from the End India Study. Kelly, thanks for joining us, and we've got Haley here as well.

audioHayleyMason21328980425 0:34

Good morning.

audioKellyMcGorm11328980425 0:35

Good morning. My greatest pleasure.

Jaimee 0:37

Oh, that's so exciting. It's a, it's a different one for us, isn't it, Hailey? To have Kelly on from the End India study, which we'll explain in a minute.

audioHayleyMason21328980425 0:44

Yeah, it is. It's, it's a first for us to have a professional on board. I like it.

audioKellyMcGorm11328980425 0:50

if I would call myself a professional, Sorry,

Jaimee 0:53

So Kelly, do you wanna just start with telling us what End India stands for and just a really quick snapshot of what it's about before we jump in a bit deeper?

audioKellyMcGorm11328980425 1:03

Yeah, absolutely. So India is, an acronym for the environmental Determinants of Islet Autoimmunity. And what we're actually talking about, islet autoimmunity is when the body starts to, for some unknown reason, Attack the, insulin producing beta cells in the pancreas. And, um, we think that with previous evidence, from other studies that,, and the increase of type one diabetes around the world, that there must be some sort of environmental trigger going on there to, to start that autoimmune process.

Jaimee 1:47

Yes. And it's exciting for me cuz my, my eldest boy who's four and a half now has, been in it since he was in the womb. So, do you wanna tell us a bit about when India started and you know, how many has been recruited and all? Of that.

audioKellyMcGorm11328980425 2:01

Yeah. Yeah. So we have actually just celebrated our 10th birthday. We recruited our first participant at the Women's and Children's Hospital in Adelaide here on the 15th of February in 2013. so yeah, that we've been recruiting since then. But I was just saying to Haley earlier that, our senior project manager and lead doctor have been working on N India. Getting it going, getting funding since, oh, 20 11, 20 12. So it's been going a while. And, um, we finished recruitment at the end of 2019 and we recruited 1,511 random number, because the last two were twins, uh, pregnancies and babies, and over 80% of those were recruited from the pregnancy. And that is what makes India. The first of its kind,, in the world to recruit babies from the pregnancy and work out what's happening in the pregnancy into early life that may trigger this, autoimmune response towards type one diabetes. And so,, we actually also recruited babies up until the age of six months. They could, uh, get, get involved and we've been following these babies yeah, for, for all that time, every three to six months.

audioHayleyMason21328980425 3:27

Kelly, can I just ask one question? Uh, we've heard you recruit. Um, participants over 10 years ago. Is there an end date to when you follow up

audioKellyMcGorm11328980425 3:36

That's a really good question, Hailey. We always wonder what that end date is, and it's really tricky because I guess we want to, follow these little people for as long as possible. Of course, there has to be an end date and. There's also funding considerations as to how long you can, pay people's salaries and freeze these samples in minus 80 degree freezers and all the expenses around it. So, as I say, we're, we're hoping to follow up children until they're 10 years of age. And at the moment, the median age, sort of the, the. The most common age of babies is, just over five years. So we've just actually received another three years of funding from Helmsley Charitable Trust and J D R F Australia, and that's a three year, block of funding. So we are definitely, as India know it, we're still going for three more. And we do anticipate that there'll be further little pots of funding, to keep following up as long as possible. But as, as you know, the, the normal n d s study visits that families know at the moment will end for them 10 years for the child. But we would like to, um, to keep tracking the, the little East because as we know, people can develop type one diabetes at all ages, not just in c.

audioHayleyMason21328980425 5:02

And that that funding issue is a key and critical element of any of these studies, isn't it? It can't work without that funding, without that backing and that background work, the legwork that goes in to getting them off the ground. Because you might hear a lot of people say, oh, well, we took part in a study and then we never heard anything. But, that's almost as key or it is key as, as critical as the information that you. gathering from these studies because without that funding, you just, you just can't do it. And I just think the wider general public aren't aware of how difficult it is and the work that goes into that. So hats off all of your team who are involved and, and doing that legwork, securing that funding.

audioKellyMcGorm11328980425 5:45

And it is concert, they're, they're big, as you say. You're right. It's a lot of work to put grants up and to, to submit them to different funding bodies and and I guess, you know, Go into this further into the podcast possibly, but all the different elements, the scientific elements, require separate little pots of funding to, or big pots of funding to, yes, to be able to really, you know, some of, uh, materials go to Germany to,, be analyzed there and, and all those associated costs and the different researchers that are involved in looking at the genetic components, for example.

Jaimee 6:19

Kelly on that. Um, can you just let us. Mean, I know because my boy's in it, but each study visit, what do the little ones go through and what's involved at home and things like.

audioKellyMcGorm11328980425 6:31

yeah, yeah. So from the. Point of recruitment. We were, um, seeing mums and bubs, well mums, um, in the pregnancy, every three months to, uh, collect samples. for mums it was things like, even a vaginal swab to look at the environment that the bubs was, growing and developing in. And, and the birth canal example, breast milk, urine. Trying to get some, handle on nutrition lifestyle. and then once Bubs was born, we were getting birth samples. So, cord blood and,, the first poo and even the first spit up just looking at the, the baby's sort of development and digestion at those early stages. And then every three months we were seeing bubs until they were two years of age again. Collecting urine and skin swabs and mouth swabs and, a blood sample. And then we're now following, now that all our babies have turned two. We are now following them every six months, ideally. But you know, we know that life gets in the way, things get very busy. so, you know, some people might just see us every year, but ideally we see the kidney is six monthly. And, those blood tests are probably the most critical because that's what gives us the indication that they have the early markers. Type one diabetes, which are these, ILO auto antibodies. They're little proteins that you can find in the, the blood that start marking this autoimmune attack on the pancreas. Um, so we do like to try and get a blood sample,, at each visit if possible, because we're trying to work out the, the exact time that. This autoimmune attack happens. but you know, obviously again, you know, they're, they're children and, if it's not happening that day, it's not happening

Jaimee 8:27

Yeah, and I must say that was one of the biggest deciding factors for us as parents of putting your three month old through. Test every three months and the guilt that goes with that. And then I had to remind myself that it's not because I've got diabetes, it's because we are trying to find information for future families and future children and e everyone. So, um, but it is the most challenging part from my perspective as a parent, even a, uh, with a four year old. So, yeah. Yeah, but you guys are amazing at supporting us as families to, to not feel like if you don't, like I haven't got a stool sample off my kid for the last couple of visits cuz he will not do it. And the trauma that I pushed him so hard one time. I'm just giving up now. So, but you know, you never make us feel guilty. The nurses are amazing and we've come from Perth to Queensland and had the same experience so.

audioKellyMcGorm11328980425 9:18

Great. Yeah. Well, the, yeah, there, there's no point in pressuring children and, and it's very difficult, I think to explain to them the importance and the, of what they're doing. At the moment, you know, we, we did an evaluation of the study recently and I think there's that sort of general understanding of helping and, and the concept of maybe helping Mummy or,, or my big sister who has type one diabetes and that the idea that they're actually helping. Future generations is quite massive to impart to children, but that's what they're doing. but you don't wanna put that kind of weight on kids So,, we are just so grateful that, um, we, we have the families sticking with us because that's, A huge part. And, and again, I guess that comes back to the, the funding as well, that, you know, when we first started the study, we thought we were just going to follow children for three years. And that's what we were saying. originally it was, you know, we'll follow your, your child for three years. And then we were given a really. Strong commitment from the funders that we could go for a lot longer. So now we're, we'd really love to follow them until they're 10. and yes, I, I guess what happens after that will be, T b a St.

audioHayleyMason21328980425 10:43

Kelly, just to clarify this, this study is only in relation to type one diabetes, isn't it? It's not looking into causes or factors for any of the other forms of diabetes.

audioKellyMcGorm11328980425 10:54

Well, no, no, because that was the, the main research question. We have just recruited people with type one diabetes as a first degree relative in the family. But, we do have a few, mums that had gestational and type two. and a couple of dads with lada. Um, but that's not, yeah, what we're specifically, powered to look at. We don't have that many people in the study that we'd be able to come up with any firm conclusions there.

Jaimee 11:25

I think with some of this research you look like it'll probably be used for years and years to come, even without the primary outcomes. You know, just looking back at what you found and then relating it as well. I know the gut microbiome and all, that's a huge part of research and that now,

audioKellyMcGorm11328980425 11:41

Absolutely. Yes. Yes, that's right. And in fact, J D R. As a, a conditioned of our most recent funding has just put a call out to international researchers to be able to access the n d s Study Library Anonymous, of course, library of samples, to be able to even progress what N India can't do. so. Yeah, we've got researchers from America and Germany and Croatia, Canada, UK already very keen to be able to access some samples to look at things like pfas. You know, the, there's a chemical that is found in. the water systems that we are drinking and, um, it's, it's in most of us already, It's a big chemical used in firefighting. yes, if you look it up, it's a little bit scary how how much, uh, this chemical is, is in our environment. And so there's researchers. With expertise in this that are, wanting to use N India samples to see if there's factors there that might trigger type one. So it's, it's an amazing library that we have created with thanks to our n India families here in Australia.

audioHayleyMason21328980425 12:57

and with, with the participants that, uh, you, you recruited or who signed up, have the majority or all of them remained on board or have for some of. There've been factors that meant they've had to step out.

audioKellyMcGorm11328980425 13:08

Oh, absolutely. Yeah. I mean, as I said, life gets in the way. So we had, um, Just to be precise, 1,473 babies that have continued, for a certain period of time in India. And then currently I'd say we have about 1300 children that are still involved. And yeah, look, there are. There's school, there's work. people move away. Yeah. We've got people now in New Zealand and the UK and France and Germany that didn't really expect to be there when they enrolled in India. And, you know, they've got lovely jobs and families and, all those life factors that would get in the way of a long-term study that you could never foresee or. When you, when you enroll in a study, you always have the best intentions, but sometimes, yeah, life gets in the way. So yeah.

audioHayleyMason21328980425 14:03

Know whether you can, answer this question or not. Any of the children you're following, have any of them developed? Type one.

audioKellyMcGorm11328980425 14:12

yes. Yes. if you have a family member with Type one diabetes, it does increase your risk. it sounds massive. It is about 15 times more when compared to the general population, but that's still quite low in, in the relative scheme of things, but it does increase your risk, and that's why we recruited little ones with a first degree relative. with, type one diabetes, so we were more likely to see some children develop it. So it's um, we have 21 children that have started in insulin. And then as I said, we're measuring in the blood. These Isla auto antibodies and I think type one diabetes is now seen in stages. It's not just bam, you have type one diabetes. These early markers, you can actually pick up, what they call stage one of

audioHayleyMason21328980425 15:09

It's interesting you'd say that just from. Uh, my experience with our eldest son, looking back now with the benefit of hindsight, I would say that at least four months before he was diagnosed, there were signs very. But they were signed. But of course, when you don't have any experience or any, contact or knowledge of the condition, you're, you're not looking for it. So it's often not till they get a lot more severe, but yeah. So it would be so interesting to know if you could go back and retrospectively look at what was happening in, in his body then to pick it. But like I say, it's only with the benefit of hindsight that you can go back and say, oh, this was happening, that was happening. And it was obviously, The onset and the start of that, autoimmune process.

Jaimee 15:57

And you're not alone with that. Hailey. I hear it all the time and the guilt parents have because, but you know, kids often in a growth spurt or, you know, there's often other reasons you isn't there so,

audioHayleyMason21328980425 16:08

You can put it down to so many things. Just as Jamie knows, I love a little random chit chat on these podcasts. it's pretty apt that we're doing this one today because, uh, about 11:00 PM tonight will be the seven year. Mark of when we first suspected, our second one had, um, type one diabetes. So it was about 11 o'clock at night where we heard our little three year old get up for a drink of water and, uh, did, did the finger prick. one of us going, that'd be ridiculous. It's not gonna be that. And the other one going, Hmm, not sure. And then, you know, then started the process. So we were just having the debate last night of it's the 27th or the 28th to die anniversary, cuz we do celebrate, if that's the word in our house. So, and we've decided that whilst we set off a hospital on the 27th, we didn't start intern or get the diagnosis. It's a, it's a very apt time to be doing a podcast on looking at the development of the disease

audioKellyMcGorm11328980425 17:08

Hmm. Well, happy anniversary for want of a better term,

audioHayleyMason21328980425 17:14

Oh, and look, we do, we, we do celebrate. We celebrate that, that we've survived, that we've learned that we've thrived. And, as far as my kids are concerned, it's another day to get a gift. So all your people are, are listening. You wear when you start these predictions because you're expected to carry them on

Jaimee 17:31

I'm sure that will,, continue as well. Kelly, that brings us, brings us to the question of the benefits to families have been in the study. I mean, I, I can see lots of benefits, but there's also lots of challenges and questions you ask yourself when you've got your child in this, do you wanna know what's the benefit of knowing? Do you wanna just elaborate a little bit on that?

audioKellyMcGorm11328980425 17:54

Well, yes, probably you are the, the better person to, to answer your own question, Jamie. Um, look, there's possibly no direct benefits in being involved to, you know, to be, that's what we say on our consent form when people sign up and they reconsent when you know the child turns three. but we did do. An evaluation recently asking families how they were going and what we could do better or, you know, what needed improvement. And, a lot of people found having that regular contact with a health professional or the, the research team, just monitoring their child for signs of, of the early signs of type one diabetes did provide peace of mind. And even if. Antibodies were found on a blood test, having someone checking in, having those early heads up that,

Jaimee 18:46

Yeah. And you're able to, I know I've seen children put onto a Libra sensor. Very early on, if you've seen the start of the, um, well, you know, positive antibody tests, then you can put the child on the sensor and start to see rises in the glucose levels are much earlier than you would see symptoms and you're definitely avoiding d k A. That's a huge advantage. And I know on your social media accounts recently, you're put up a young one who, who showed positive antibodies early on, and then I think a sibling had gone into D K A, but this. Brother was able to avoid that. Now that's a huge benefit. So,

audioKellyMcGorm11328980425 19:23

Yeah. Yeah. I, that's, that's certainly, what we see the benefits of, of screening effectively is, is what we're doing for, these little people just to avoid them getting sick, because obviously then we monitor them quite closely once we find antibodies. also, I don't know, Jamie, since you've moved and you've had some different nurses, but you've, you've experienced the beautiful nurses in WA and I know how many people love their Indian nurses in wa, you know, around the country. But Alex,

Jaimee 19:56

Alex

audioKellyMcGorm11328980425 19:57

Alex and Ellie are beautiful people and I think people have really benefited from the ongoing relationships with their Indian nurses in that way.

Jaimee 20:09

Yeah, and I think, you know, even your Queensland nurses, and we've been through a couple of them, you just had a change now. Absolutely beautiful. I mean, Richie, my boy, remembers, remembers them and. They're always, you know, they make it fun, as fun as possible. You've got the virtual goggles, which

audioKellyMcGorm11328980425 20:27

the vrs a hat.

Jaimee 20:28

they didn't work at the last blood test. But, um, the, the time before that, they're amazing. He didn't even flinch. I always find the, the lifestyle questionnaires. Uh, bring up some stuff for me in regards to what I'm feeding my child in case something in there is found to be the trigger. But then I have to remind myself that it's so common that it's, it's not whether it's healthy or unhealthy, it's just

audioKellyMcGorm11328980425 20:54

Yeah, and I, and actually Jamie, it's not, we're not just asking about food to see if food might trigger it, and I think that's probably unlikely, to be honest. We're actually be, the food informs the. Microbiome. So that's what we're looking at is one of the big things we're looking at are all the viruses and bacteria and fungi that live naturally in and on our bodies. And obviously the food and fluids that we intake, I impact our digestion and what's in our gut. So that's

Jaimee 21:28

questions around pets and smoking in the house and, whether you've given your child probiotics, if they've been on antibiotics. So

audioKellyMcGorm11328980425 21:34

Yeah, there's no judgment. No, judgment. it's all about what's influencing the child, what's in their environment.

Jaimee 21:44

Yeah. And for me it's not about the judgment. It was for me, it was when they were little introducing solids and then handing over to daycare and sort of saying, This is what they've had. And I don't want certain foods introduced to early because I know it's going to change the gut microbiome. I dunno how, but, you know, I would overanalyze everything for my first child. So, yeah, it, it was just that awareness. But it's, it's not necessarily a negative thing, it's just not, everyone's gonna overthink it.

audioKellyMcGorm11328980425 22:16

Oh, I, I think it does make you think more, doesn't it? When you're having

Jaimee 22:20

Which could be a good thing, you know, an awareness around that. But Will, yeah, will we ever know? Possibly. And then it'll be so interesting. So is there any major findings so far? I think we are starting to wrap up a little bit. Is there anything you can share that is a pattern or.

audioKellyMcGorm11328980425 22:37

Yeah, look again. Um, we. Ongoing. So we are, we're actually still just finalizing all the pregnancy birth data and the general cohort data, being able to get all the final, key pieces of information that, we can then embark on, major, Nesta case control study, which will start coming out. Hopefully towards the end of this year, we should start seeing some more interest. Findings from India. But in the meantime, obviously we've been doing these sort of planning preparatory, small sampling studies and we've found quite a few differences, in the pregnancy, with women. With type one diabetes and that don't have type one diabetes in their microbiome. So we are finding that there's different types of bacteria, different viruses, when you compare mums in the pregnancy with type one and those that don't have the condition. And subsequently, we've also found differences in the stall, in the poop of babies, of mum. With type one diabetes compared to those who don't have the condition. also found, more gut or intestinal inflammation with moms that have type one diabetes. Um, I guess these findings are really important because that provides us opportunities to intervene and try and improve outcomes for mums with type one diabetes and their babies cuz there's a higher risk of, Pregnancy and birth complications for mums that do have type one. So maybe there, there's something in there. But on the flip side, babies of mums with type one diabetes have a lower risk of developing type one diabetes. So is there some protective effect of those changes? We, this is something that we're, we're going to be looking a lot more closely at.

Jaimee 24:36

It's very exciting.

audioKellyMcGorm11328980425 24:38

Um, yeah, so there's differences in fungal infections. we also had a, you know, all those annoying surveys you did of, um, the, the E P D S about pregnancy, like stress and and depression and anxiety around the postnatal periods with. Analyzed all of those. And we've actually found that there was no difference between the, the mums with type one and not having type one. And that the, blood glucose control was really good in our cohort of mums, close to target levels. Yeah. So, uh, we were really reassured by, the surveys that the findings we've collected so far. Given the challenges that women with type one diabetes often face during their pregnancy and, and postnatal time. so that was a reassuring finding. Yes. But we have just to say, we have all our, publications and summaries and some little videos on our website, under a little. Publications tab. We also have a news link as well. So when there's newsletters come out or, um, major updates, we pop them on the website as well. So they're all there for people to watch videos and

Jaimee 25:46

perfect.

audioKellyMcGorm11328980425 25:47

update.

Jaimee 25:48

Thank you so much. Is there anything you wanna add before we, um, sign out? Anything we might have missed?

audioKellyMcGorm11328980425 25:55

Well, I mean, the big one for me is, you know, Haley mentioned how important the funding is, but of course the most important thing is that people participate in research. Like this. without people like you, Jamie and your little fella, we wouldn't be able to find what the causes of type one diabetes are. So you can have all the funding in the world, but if people don't help, um, don't actually put their hand up to participate, then it just wouldn't happen. So thank you. Thanks to everybody

Jaimee 26:27

thanks. to everyone. Yeah.

audioKellyMcGorm11328980425 26:28

absolutely, anyone who participates in research is a complete hero.

Jaimee 26:33

And yeah, and it is a lot in those first, um, when you said three month visits for your newborn and that, and it's hard. Yeah. So absolutely. I'm so glad we've had this opportunity. I'm so glad we chose to opt in, but I completely understand why people don't as well.

audioHayleyMason21328980425 26:50

I think there has to be a sense of altruism in going into those sorts of studies. I definitely would have put ourselves into the study had we been, eligible, but by the time I was pregnant with our second one, I, we, we weren't, we wouldn't have fit the criteria. But, I think for a lot of people, if there's something that any of us can do, no matter how small or insignificant we think that contribution is, if you can help somebody else not develop, one diabetes. I think so many people would do that. And that's not to say that life is terrible with it because we all know we can live and we can find our ways around those, those hurdles that we come across. But at the end of the day, it is a lifelong chronic condition. So if you can help in any way prevent somebody from having to go down that journey, then

Jaimee 27:46

To even delay, isn't it? Hayley, we've talked about. Delay in, and that's might be where this research initially leads delay at a year, two years, as Kelly was saying, stage one,

audioKellyMcGorm11328980425 27:55

That's right. Well, I, I can chip in another thing. You know, I don't know if you'd come across the tolima uh, medication that,, was studied in the US a couple of years ago. It was found to delay type one diabetes by at least two years, which is uh,, two years without insulin. And, um, beta cells is. Great. Two years. So that's actually been f d A approved in America and will eventually come to Australia. And there's a new body here called aic, the Immunotherapy Collaborative for Type one Diabetes that is looking to progress immunotherapies, for all stages of type one diabetes. And that just had a launch last week. So there's actually a reason. Have your child screen for type one diabetes because it's looking like we now have some trials coming to Australia that you could participate in. That may delay.

Jaimee 28:47

the technology improves. So if we can delay the progression and while the technology improves, cuz I know there's the stu um, the. The conference over in Paris as we record this at

audioKellyMcGorm11328980425 28:58

Yes.

Jaimee 28:59

And, and they're, they're all saying that bolus in counting carbs could be a thing of the past. And

audioKellyMcGorm11328980425 29:05

Wouldn't that be great

Jaimee 29:06

you know, it, it's just like, so two years of no insulin and delay is huge when

audioKellyMcGorm11328980425 29:13

I'll send you the links, Jamie, for the, for the Toles study and for the AIC group here in Australia,

Jaimee 29:19

And I'll pop them in the show notes for people as well. Yeah, yeah. All right. We might let Kelly get on with her day and, thank you so much for joining us. we would love to get you on again down the track, you know, in another year or two

audioKellyMcGorm11328980425 29:33

Absolutely. Yeah, well certainly when these, um, these case con control papers come out, it would be certainly worth sharing those again. That'd be great.

Jaimee 29:44

fantastic. Thanks Haley, for joining us as well.

audioHayleyMason21328980425 29:46

Thank you for having me. Thank you, Kelly.

audioKellyMcGorm11328980425 29:48

Thanks Haley. Thanks Jamie. Lovely to see you.

Jaimee 29:51

Thanks ladies. Have a super day. Bye.

audioKellyMcGorm11328980425 29:53

You too. Bye.