Opinion
Video
Need for Increased Screening and Clinician Education, and Greater Awareness of Clinical Trial Opportunities
Author(s):
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.
Natalie Bellini, DNP, FNP-BC: 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.
Natalie Bellini, DNP, FNP-BC: 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.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: 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.
Natalie Bellini, DNP, FNP-BC: 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.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: 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.
Natalie Bellini, DNP, FNP-BC: 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.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: 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.
Natalie Bellini, DNP, FNP-BC: 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?
Natalie Bellini, DNP, FNP-BC: 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.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: I think that would make a lot of sense.
Natalie Bellini, DNP, FNP-BC: 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.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: 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.
Natalie Bellini, DNP, FNP-BC: Absolutely.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: 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.
Natalie Bellini, DNP, FNP-BC: 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.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES: Thank you for this great discussion and thanks to our audience for tuning in. If you enjoyed the content, please subscribe to our e-newsletters to receive upcoming med cast episodes and other great content in your inbox.
Transcript Edited for Clarity
