Sumita Singh

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In this MEDcast® episode, Diana Isaacs, PharmD, BCPS, BC-ADM, CDCES, and Natalie Bellini, DNP, FNP-BC, BC-ADM, CDCES, interview Sumita Singh to discuss her family’s journey as they navigated the challenges of their daughter’s T1D diagnosis and decided to enroll her in a clinical trial for a T1D treatment.

Embracing Research and Finding Support to Manage Type 1 Diabetes

When we think about a family that gets diagnosed with diabetes with no history of type one diabetes in their family, we forget as clinicians how difficult that can be. And to hear her words talking about the struggles that they had, and they're looking for answers for this child that was eating excessively, that was sick, that fell asleep at school, was just heart-wrenching.

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: 

And what came across as feeling like, they should have been able to recognize the signs, but how are you supposed to know? There are so many different conditions out there and you never think, if you have no family history of it, you never think my child will develop type one diabetes.

: I could hear her pain in the discussion, that parent guilt. But it also is very interesting how quickly they turned around because in the trial that they're in, they had to decide within the first 6 weeks of diagnosis. And you and I both know families that are diagnosed with type one diabetes, the first 6 weeks is a complete blur. You don't know your own name; you look at food differently and you are struggling. She must go back to school. There were a lot of challenges that they had to overcome to make a decision to enroll themselves in a trial hour from their home.

I know I'm amazed that they just had the wherewithal to say, oh wait, let me look for a clinical trial to find one. Because you're right those first few weeks, you're just trying to navigate how to check blood sugars and taking insulin shots and figuring out new technology and the eating. And so it is so much to take in. And so it's hard. Most people don't think to seek out a clinical trial like that.

And what she did mention was going to something called clinical trials.gov where you can search all kinds of different medical trials in the United States. If you're looking specifically for type one trials, you can go to the JDF website, jdf.org. And they have trials specific. They have a site that is specific to look at trials for patients newly diagnosed patients who have had type one diabetes for long periods of time. And you can do it based on how far away you want to do from your house and all kinds of different other parameters. And you can put those in and it will pull up what's available. People don't know about those though, especially the day they're diagnosed. What do you do? This family was very educated, and it helped, it helped them get to where they needed to be very quickly.

And I couldn't help but think if we do start doing more global screening, situations like this we could catch a little bit earlier and it would give people more time. A lot of people unfortunately are diagnosed when it gets to be acute and in diabetes ketoacidosis or DKA. And if we can screen and recognize it earlier, it would allow everyone more time to process it. And in theory also contribute more to getting more people enrolled in clinical trials and doing more research.

And I believe in my heart that if we can avoid the DKA, we can also preserve that eyelet cell function. And that's a big part of all, but we'd love that for every patient. I never want another patient diagnosed in DKA. I want them all diagnosed in a routine screening versus full-blown blood sugar 900 ICU. That's a horrific way to go

And it's interesting because of course we see a lot of cases diagnosed in kids, but I work with adults, and we see a lot of autoimmune diabetes of adults. And it's a slower progressing type one diabetes. But the problem is a lot of people are misdiagnosed for type two diabetes. They don't get their auto antibodies checked. It's just assumed they have type two diabetes. And that unfortunately it can lead to a lot of frustration because the typical drugs are just not working. But unfortunately, if someone becomes acutely ill also, we can see cases where people then go into DKA and get hospitalized. And it contributes to worse outcomes by not having this information checking for those auto antibodies.

There's going to be a big curve in educating screening now because there's something we can do. In the past there was nothing to do, so we didn't screen, it was always this the NIH funded DPT trial, but other than that we didn't screen people. If your child got diagnosed with type one, we'd screen your children if you'd like us to, or you guys, you, and your husband. But now we have something we can act upon, and this family chose to act upon that, which I think is an amazing.

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES

: It is so amazing. And in my head what I'm thinking is how can we get this information to more people? Because this was a very well educated, like motivated family it sounds like. And we know people have all kinds of barriers and obstacles that make finding this information difficult. And even for them it was still difficult to find and get enrolled in the trial and everything. I'm hoping screening will increase awareness, but I'm also thinking in my head what else can we do to really increase knowledge of diabetes? And who do we screen? Do we screen people maybe that have family histories of autoimmune conditions? Because we know, like in her family, she was the first one with type one diabetes, so how was that even supposed to be right on their radar?

But she wasn't the first one with an autoimmune disease. Do we start there? Obviously in the diabetes prevention trial we started with relatives of someone with type one because those people have the highest risk. But then where do we go from there? Because most often you don't have someone else in your family, but is there an autoimmune disease and should we start with those people? My gut says absolutely. That's where we start.

One thing, that I think we should bring up is that there have been several studies using teplizumab and there have been studies using and what it's approved for today is a 14-day infusion. There are ongoing studies that uses a 12-day infusion and we're going to talk about this more in other episodes but one of the reasons is they're trying to make it as easy for patients to get the infusion in as possible and saying it's only one weekend, I think is going to help with that.

That's an important clarification, right? The FDA approval is the 14 days but in this specific trial that Bella was enrolled in, it's a 12-day infusion and we may see different versions of this going forward in the future but for now, it's the full 14 days. I also just wanted to stress, we know education on this topic is important for physicians and for other healthcare professionals. Knowledge about well, how to screen, the fact that there is an agent now that is FDA approved to help delay the progression from stage two to stage three type one diabetes and that it's being studied for other forms of type 1 diabetes. A lot of work to keep everyone educated.

Especially in primary care or in pediatrics that everyone's knowledgeable about all these different symptoms that can occur so that if there's even a hunch, like someone's thirstier, they're losing weight, they're hungry or feeling fatigued that we don't hesitate, that we check. We check glucose levels, or we check A1Cs or we check auto antibodies so that we can provide the best care and prevent any acute complications like DKA whenever possible.

And the challenge for the education part for all healthcare professionals is we all are going to start thinking, is this really my job? That's not my patient. I practice endocrinology. The patients without diabetes don't have diabetes. They're not coming to me to get this screening, but I do believe that it is my job to inform my patients with type 1 diabetes that there is a drug now available to delay the onset for their family members and that they deserve that education and then they can decide what to do with it from there. They can take handouts and go to their pediatrician or go to their primary care provider and ask and seek their own care at that point.

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Videos

Drs Diana Isaacs and Natalie Bellini highlight the need for improved screening, greater awareness of clinical trial opportunities, and clinician education to improve early diagnosis and outcomes for people with T1D.

Need for Increased Screening and Clinician Education, and Greater Awareness of Clinical Trial Opportunities

Speaking of that, it's exciting that teplizumab is approved now for the delay of the onset of type one diabetes. I know you've been during this other clinical trial with it when you got this news, but what you think about that, and other research developments related to this?

 The first thing I did, of course I congratulated the group the CHOP team, they're the ones who are doing the hard work, and the patients. But the first thing I did was I went back on clinical trials dot gov to see what other research there is and sadly, right now there is no drug that's being researched. My hope is that this should open more investment in type one both research and drug approvals. I think my hope is that people like me and others who participate, talk about, we did something, it resulted in something. The odds are slim but unless you do participate in research, nothing happens. We're having those conversations. I'll tell you a little personal story. I was at a dinner with fellow parents, and we were talking about participating in clinical trials and such. And of course, I advocated for it. And one of the parents whose child had been diagnosed for a long time, said they had the opportunity to participate, and they chose not to. And another parent said what if it doesn't get approved and what do I tell someone whose child has been diagnosed? There were lots of what ifs. And, my view is, let's be part of the answer to the what ifs on those. I don't even know if Bella got the drug. We won't know until later this year, and that's OK. Quite frankly, we don't want to know although my parents keep asking. But she's super happy that she did this and she talks about it and that gives me joy.

 I have a question about, you have mentioned that a couple of times now that you have another child, have you screened your other child?

 First thing we did. We screened her we screened ourselves both of us. It's a worry, we try not to talk about it. But we did screen. All 3 of us screened. We try on that.

Excellent. I'm a big believer in trial and that I think that it's important for us to know. But we do have patient people with diabetes who say, I don't want to know if my child is going to get diabetes, I'll know. It's a very different thought process and we need to respect everyone as clinicians, as people learning to open up in the world and talk about our differences and our similarities. But I'm a huge believer in let's see what we can do as opposed to not.

 We did it. My younger daughter's Pia and for the first 4 weeks, you don't know your left hand from your right hand. You're doing math and we have binders. And you are trying to be precise, and I think for us food, I mean we're, we're an Indian family, so food is like our love language. Everything is around cooking and, try cooking Indian food with a precise recipe and calculating carbs, it's not going to happen. I spent a lot of time initially on just the food part of our life because that's a big part of our life. Once we got through some of that, or at least we could see some light on the horizon that we'll figure this out. I think by week 5 we had all tested, we'd got the trial net kit and we had done the testing and the timing of that was important because at the same time we were also in discussions with CHOP about the clinical trial and what I was connecting the dots on is a, I would not want my second child to go through what Bella went through. That was 6 months of hell, and she kept telling us, we just didn't connect the dots that this was type one diabetes. So, I wouldn't want Pia to go through that. And if she knew and teplizumab did get approved, then there would be something we could do about it. We could give her something to refer. I suppose knowing is, being an informed consumer, if you like is better. But I get the point of view that you'd rather not know and enjoy your life and be happy until the inevitable happens.

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES:

I think with the approval of this drug, at least we hope there will be a lot more screening happening. Speaking about that, I'm curious what advice you might have for physicians or others in diagnosing or managing people that have type one diabetes or, screening and all that kind of stuff?

: You start with the pediatrician because all of this, most of the diagnosis is happening at that level, and then you bring the specialist in and I can't say this enough I happen to sit now on the JDRF local chapter board and I'm always talking about pediatric education, like a pediatrician education, if you like. They must talk about this. It's life changing. Just like Crohn disease and all these autoimmune disorders. And screening for those, let's just do that. If we had done that, we may have taken a different path towards Bella's care. To me, that's number one. I have 3 passion points. One is screen, screen, screen, have the pediatricians talk, you can't do that enough. It's such a teachable moment, if you like, for families. The other is nutrition, the nutritional education to make it culturally contextual. All the information we got when we left the hospital, that's just not food we cook. I had to be self-directed, and not a lot of families have the time or the means to be self-directed. And connecting me to someone of my background who understood how I could cook my food differently would've been so valuable. Would've saved a lot of heartache in the initial weeks. I think the third thing is much more sort of on the science side of it is there continues to be very little representation of people of color in clinical trials. And having that is hugely important, because everyone's physiology is different. We don't know if Bella too teplizumab but it likely will act differently for my genetic code than your genetic code, if you like. So again, if we all want to benefit from it, we all need to participate in it. I want to see all colors, if you like, represented in these studies.

We've learned so much today from you. Thank you so much.

Sumita Singh, a T1D advocate, discusses with Diana Isaacs and Natalie Bellini how teplizumab and other advances are providing hope to the T1D community and talks about the challenges and needs of a diverse T1D patient population.

Impact of New Treatment Approval and Other Advances on the Type 1 Diabetes Patient Community

 Then what? How were you approached about research opportunities, or did you find those as well? It sounds like you did so much of your own research.

 We found it, like I said, at that time right before Bella's diagnosis, I worked for a published scientific. It was in my, if you like in my context and clinical trials dot gov, I was aware of that and I look back and, I'm not sure what triggered me, my work experience and just being a problem solver and both my husband and I, by day 3 actually, a lot of parents asked, we were told when their child is diagnosed, Hey, what about the research and what about a cure? And of course, we asked all those questions. We asked about stem cell research and such. But it was important for us to do 2 things. One is, to participate in the science associated with whether it's life improvement for a child or cure on anything along that spectrum. We want to be part of that journey. We want to bring Bella into this experience with science on her side, that was important to us. Not take a victim mentality. The second night, my husband and I, were both on clinical trials dot gov looking at what's the cutting-edge research. There were 2 trials in fact, that I had reached out to, there was one at Yale for a blood pressure drug you might have heard of, and looking at whether that could be applied for early onset type one diabetes. And then there was teplizumab, and we applied to both, we missed the window for the study at Yale by a week. And we barely made the window for teplizumab. If I tell you how we got in the trial, someone could make a movie. It was of funny if I look back, that process.

I was just going to say, what was it like getting involved in a clinical trial? Whatever you can tell us about the experience. Any hesitations? Were you nervous at all? Was she nervous at all?

: Absolutely. We haven't done clinical trials as a family. We knew the idea of what this is about, and we understood they're double-blind studies and we didn't want to be in a phase 1, we wanted largely to be in a phase 3. And those were some of our considerations. But it was nerve-wracking to be honest with you because you're walking into something, you have no context. And its clinical research, there are downsides and risks associated with that. We studied all of that. We did talk about that. In fact, Bella is very close to both sides, both grandparents, my parents and my husband's father, his mother passed away a while ago. We brought the whole family together. We all got together, and we talked about the trial, and we didn't influence anyone. My parents were asking me questions and Bella was asking me questions. We all collectively as a family concluded that, the end of that discussion was even if there is a 1% chance that you can benefit, we want to take the chance. We're a soccer playing family, so every shot at goal missed is a shot you don't get. We were going to take all the shots at goal. But the process, the journey was pretty interesting. If you'd like, I can go through that.

We would love it. I think some of the feedback that we've gotten is who takes all that time off? Who would do this? And I think both Diana and I as clinicians have had this conversation and said we would, we would find a way. So, tell us about finding a way to do this and set your family up to, to get Bella what you wanted her to have.

 Yes, there are considerations. And I have the study binder in front of me and the letter that we had to sign, it tells, you all the commitment and they're very clear that you could be on the placebo. There are all these adverse effects and that's what they need to do. They're doing research good on them for having all the documents in front of us. But they talked about 35 extra research visits. We live in northern New Jersey; the trial was in CHOP in Children's Hospital in Philadelphia. It's a drive for us, we both work. We had to figure out that process. Every time we go, we must get blood tests and urine tests. She had to be 12 separate days 6 month or a year apart, getting daily infusions. We had to stay in Philly for those 12 days. So that's disruption in education. She had to do the mixed meal tolerance test 5 times, which if anyone's done it, it's it takes a toll on you because from 10 o'clock at night till the time you take the MMTT, you can't eat, you can't be too high, you can't be too low. Imagine doing that as a newly diagnosed type one. So, we knew that there are risks in life in everything you do. You can ride a bike and things can happen and as a type one you quickly learn life is about planning. We planned and what we tried to do is the first 12-day infusion we did during spring break, so it wasn't disruptive to her. And the CHOP team was, incredibly accommodating. There are not a lot of high schoolers who do this largely for the reasons you've mentioned. We did the trip 35 times there on Fridays, so it was not too disruptive on school schedule. We stayed in Philadelphia, they paid for the hotel room, and we stayed there. And thanks to hybrid learning, she could do the schoolwork. Her academics were affected the second time around because she was in the throes of freshman year of high school. She's not getting her PhD, doing research in cancer. It's freshman in high school. You must have perspective. I think there are considerations. Every family needs to make those decisions but to us one of the biggest other than being quite frankly, so excited that it got approved one of the biggest outcomes and benefits was that Bella got to spend time with the best minds in clinical research and type one diabetes. She would sit there, and we'd typically would take a step back and she'd ask all kinds of questions, I think the more kids, I say children can advocate for themselves and ask those questions, be vulnerable, talk about their lives with diabetes as opposed to having an endocrinologist visit, which is just a chore. It made it interesting, and we made the Philly trips super interesting. Her father went to college there, so we would go to all his hangouts, and we would do trips there. We'd bring our younger daughter there. Those were hard visits. But we bookended them with fun and we talked a lot about her journey and what she's experiencing. I recommend it to anyone who can get the opportunity to participate in research. It is profoundly valuable to do that. Yes, it's demanding, but life as a type one is demanding, period. So, it's a burden, but you can plan around it, is my view.

That's great to hear. And thank you. We need people to do research, otherwise we would never have advances.

Sumita Singh, a T1D advocate, discusses her family’s decision to enroll their daughter Bella in a clinical trial for T1D and shares their experience.

Sumita Singh

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