Barriers to Screening in Type 1 Diabetes
Anita Swamy1, Marissa Town2, William H Polonsky3,4
1 Chicago Children’s Diabetes Center at La Rabida Children’s Hospital, Chicago, Illinois; 2 Children With Diabetes, West Chester, Ohio; 3 Behavioral Diabetes Institute, San Diego, California; 4 University of California San Diego, La Jolla, California
Abstract
Since the consensus in opinion and publication of scientific evidence to support the staged progression of Type 1 diabetes (T1D) in 2015, individual and collaborative efforts to identify people in early stages of T1D have emerged globally providing further supportive evidence of the benefits of islet autoantibody screening. Despite strong support for screening as a research/scientific tool, many healthcare providers have been reluctant to implement protocols in their clinical practice for a variety of reasons. Barriers range from clinical and policy-based in nature to concerns of patient burden and implementation. In this article we hope to identify current hurdles to T1D autoantibody screening both in people at risk for clinical disease and the general population and provide practical solutions or steps that clinicians and organizations can take to overcome them. Disease education for patients has been shown to reduce psychological patient and family burden. Several groups have proposed outlined steps clinicians could consider when screening and monitoring individuals in their practices. Choices with both short- and long-term solutions can be endorsed by clinical teams and research groups to enable a more seamless approach for T1D autoantibody screening and spread the message that T1D autoantibody screening provides patients, families, and healthcare providers with clinically meaningful benefits, arming them with helpful knowledge of the risks for clinical disease.
Introduction
The last several decades have been rich in efforts to establish clinical protocols and proof of concept studies for identifying individuals in early-stage Type 1 diabetes (T1D) through islet autoantibody screening programs. Islet autoantibodies first were discovered in the early 1970s in parallel with the observation of insulitis and the association of pediatric-onset T1D with certain human leukocyte antigen (HLA) alleles and abnormal T cells.1 Fast forward forty years, in 2015, the American Diabetes Association, Endocrine Society, and JDRF published a scientific statement describing the three stages of T1D and provided a staging classification system designed to provide a framework for early identification of T1D.2 This framework could be used for the design of clinical trials aimed at preventing clinical disease and promote precision medicine. It has also been adopted in clinical practice to improve upon the identification of individuals with T1D, with or without the presence of clinical symptoms.
Despite strong support for screening as a research/scientific tool, barriers exist that impede healthcare providers from the recommendation and implementation of T1D screening in their clinical practice. These barriers include those that are clinical and policy based in nature, concerns regarding patient burden, and logistical barriers. Identifying the barriers to T1D autoantibody screening in people at risk for clinical disease (Stage 3 T1D) and the general population is critical to develop practical solutions and steps that clinicians and organizations can take to overcome them.
With our collective experiences as healthcare providers and T1D patient advocates, we have come together to discuss some important topics on T1D autoantibody screening and provide our professional perspectives on existing barriers as well as thoughts on how best to address these barriers.
Clinical and Implementation Barriers
There are gaps in clinical practice that can impede T1D screening in healthcare provider offices. Identifying which patients should be screened for T1D and which clinical provider is best poised to implement screening has been debated. Additionally, the practical execution of screening may be challenging to implement.
How do you think we should be identifying people who are at risk for T1D?
Anita Swamy: “The biggest [group] is relatives of children, whom we see in the clinic with Type 1 diabetes and discussing with them how we screened for it and what the significance of the screening is. …there are some people who are very anxiety ridden about the thought of having another child with Type 1 diabetes so explaining to them that this screening can actually help in the long run would help mitigate their anxiety.”
William Polonsky: “I agree. I was just thinking about what other groups [we] could even imagine, but I think that’s kind of it, right? I mean, at least nowadays.”
After some consideration,
Anita Swamy: “I think the folks [with additional autoimmune diseases], so if you have multiple [celiac disease, hypothyroidism, possibly Addison’s disease or additional clusters of these autoimmune conditions], I would then say we should screen for T1D.”
William Polonsky: “Yes [I agree].”
Which group of healthcare providers will be responsible for identifying these individuals? Will it only be endocrinologists? What people do you think are going to be playing a major role?
Anita Swamy: “I think we would start with endocrinology offices, everybody involved on the team.”
William Polonsky: “In particular, the certified diabetes care and education specialists (CDCES).”
Anita Swamy: “I feel like we need to be able to [expand it] so that we can advise the primary care practitioner (PCP) on how to do it. The PCP that takes take care of the family, wherever that may be.”
Marissa Town: “…general pediatric groups, because most of these children are not going to be seen in endocrinologist’s offices, right?”
Should the PCP be responsible for initially ordering the islet autoantibody screening test?
Anita Swamy and William Polonsky: “Yes.”
Do you think that they (PCPs) should also be responsible for the follow up and/or the potential monitoring of screened patients?
Anita Swamy: “That’s a lot to ask because I feel like even as an endo, I [have only recently] learned a lot [about staging of T1D]. I think there is a lot of confusion and a lot of misunderstanding. [In regard to T1D screening, we have a lot to] figure out and a PCP may not be aware of that. I think that is a big ask of a PCP to provide that [kind of] guidance. I think it has to be the CDCESs and our offices.”
How do you think that we should be following up or subsequently monitoring patients that test positive for autoantibodies? Similarly, what about patients that test negative?
Anita Swamy: “I think for those who are positive, we just routinely screen for hyperglycemia. I think the easiest would be to do an HbA1c. In all honesty, an OGTT is pretty limited…. It’s really tough to get an OGTT in people. [In my experience] I have told a PCP what [tests] to order and we would do is about every six months….so that PCP would just routinely order an HbA1C, and if it were elevated [over 5.6], we [my clinical practice] would see that patient.”
Marissa Town: “I’m picturing like a flow chart that is probably both healthcare provider and patient friendly.”
Can you describe the access and accessibility of islet autoantibody tests?
Anita Swamy: “So in our practice and where I am, which is Chicago, it is extremely accessible. We have two institutions that are members of TrialNet (Lurie Children’s Hospital and University of Chicago). We have a lot of availability, and we do see in our particular practice people from all kinds of areas, so we try to find the closest location for them and tell them to contact the TrialNet center. Additionally, we do have TrialNet present at all the health fairs, so whether it is JDRF or ADA (American Diabetes Association), they are always present to discuss [screening] with people. Access is great currently in terms of locations and facilities. I think the education is what needs improvement so that patients understand ‘the why’ and that [screening] is simple.”
Marissa Town: “I think you would get a major uptick [in autoantibody screening] if you didn’t [necessarily] have to order [the autoantibody test] online [and could receive a finger-prick driven test in a healthcare provider’s office]. Honestly, young parents are probably fine ordering it online, but you never know. There is a digital divide as well in this country, so I am thinking about all the people that don’t have access [at home] and have to go to the library to order [a screening kit].”
Do you think clinicians will just do this [determine who identifies patients, create screening and monitoring protocols, identify the best assays to use] on their own or will they be waiting for guidelines? From where?
Anita Swamy and William Polonsky: “They are waiting for guidelines.”
Anita Swamy: “Standard of Medical Care in Diabetes (in children and adults).”
William Polonsky: “Standard of Medical Care in Diabetes; stage 1 and stage 2 T1D.”
Anita Swamy: “I would say [anything from] JDRF, ADA, Pediatric Endocrine Society, Endocrine Society, American Association of Diabetes Educators, American Association of Clinical Endocrinology [would be appropriate]- consensus statements, expert opinions. I think they are all helpful.”
Psychological Barriers
T1D, like other chronic diseases, present patients, caregivers, and families with many challenges, including psychological ones. Emotions and perceptions of risk can impact decision making and the attitude by which people view the lens of the world in relation to disease.
What do you see as the barriers to getting T1D screening?
William Polonsky: “The individual may only view this as a potentially negative experience, with little upside ‘I am going to end up feeling doomed. Anxiety; this will just give me something else to worry about.’”
Anita Swamy: “It’s the work [on behalf of the patient or family]. I have to go somewhere. It’s awesome that I have you with Lurie Children’s, but it’s downtown. How do you get there? There’s the physical getting someplace. Parking is extremely expensive where we are. [Additionally], how do I manage this? Am I ready to know that I have T1D? That’s a huge thing. I think some people don’t want to know.”
Marissa Town: “I think one of the biggest barriers to screening is knowledge. Just knowing what ways [people] can get tested [is important]. It is nice now that instead of only being [able to screen through] TrialNet, we have the at-home screening kits. [Additionally], the other barrier is parental fears or people’s fears in general about what the results may be. I think it is hard because we don’t have a preventative treatment available, so there is less motivation to get screened.”
What is the perception of the risk vs benefits to screening?
William Polonsky: “Most parents [or family members] are likely to know very little about the benefits of screening, but, with little hesitation, they will probably be able to tell you about the likely negative (psychological) effects. As a result, the internal calculation might be: ’Screening will be burdensome; I don’t see any obvious benefit, and it is just going make me anxious and worried, so why would I bother doing that?’ To me, this is the key obstacle.”
Marissa Town: “I was just talking with a peds endo …and a psychologist …and they were talking about how split their team is and some providers now because of (difficult) experiences …don’t even want to recommend screening for their kids. The physician was saying, well, that’s not fair. It’s not my decision. It’s the family’s decision, which I completely agree with. But, this is a barrier that a lot of people are going to experience because their providers might not tell them. Right? And that is back to that first barrier of knowledge.”
Does the availability of an intervention of any type in this early-disease state change the risk/benefit of screening?
Anita Swamy: “Yes, for sure.”
Do you think that there is a difference between the stressors that one may face given a diagnosis of early-stage (stage 1 or 2) T1D vs the stressors that someone may face if they were diagnosed with stage 3 T1D?
William Polonsky: “There is a shift happening right now when we talk about stage 1 and stage 2. Up until recently, many of us would have said, ‘Oh wow, you know this means you’re at risk for developing T1D,’ and now we’re saying, ‘No, no. It actually means you have T1D. We are just catching an early state.’ That whole mental frame is so different. Before now, these early stages were just seen as indicating that something might happen eventually at some point, but it didn’t really mean much of anything else.”
Do you think the part of psychological barriers is the understanding of (or lack of) T1D screening of the healthcare community clinicians and educators? Do you think that impacts patients and their subsequent response?
William Polonsky: “I would bet if you put 100 diabetes healthcare professionals in a room (even if half of them are endocrinologists), I bet 99% of them would say that stage 1 and stage 2 T1D is not T1D. They would say you are at risk for T1D. I don’t think that this important shift [in the healthcare community] has happened.”
Marissa Town: “There is definitely a role that the providers have in this. I think this speaks to, just like everything with T1D, [the disease] is not a monolithic experience. It is so individual and having a provider present you with what options you have is going to be the only way that we should and can move forward…For better or for worse, we need healthcare providers to provide families with information. Give them as much information as they can and tell them why we offer this [type of] screening, and then on the flip side, the providers need to know how to like handle that support.”
Opportunity for Change
Great focus lies on educating physicians and families affected by T1D about the elevated risk of disease for their loved ones. Professionals working in the T1D field (including clinicians, policymakers, and patient advocates) have long been working towards a shift in introducing T1D screening to the general population. At least 85% of newly diagnosed stage 3 T1D cases occur in individuals without a family history of disease.3 There still exists some debate as to whether or not everyone should be screened for T1D and how to implement this screening. Collaboration between T1D professionals (healthcare professionals, policymakers, patient advocacy groups, clinical trialists, etc) is needed to employ practical strategies to make advancements in this paradigm shift of autoantibody screening for early T1D detection.
Are there any benefits to the general population being screened- now or in the future?
Anita Swamy: “[In regard to] general [population] screening, as a pediatric endocrinologist, I would love that, but as someone that has briefly done private practice, it’s kind of beaten into us to consider cost versus benefit ratio or risk. And so I think what is the likelihood that I would detect something?…. I say we start with relatives and then if screening becomes more commonplace, then consider expanding it.”
William Polonsky: “Global testing? At this point, I can’t see it, but I do wish there was a good reason though.”
Marissa: “I think it would be great because so many kids that are diagnosed, like my neighbor with no family history. [The child] was in the pediatric intensive care unit for 5 days. It was a trauma for the whole family. If we can get everyone screened, we could really reduce the amount of DKA (diabetic ketoacidosis) [at diagnosis].”
Are there examples of things that would sway you to want to screen the general population? What kind of things would tip the scale of benefit?
William Polonsky: “I don’t know, the rate is so low in the general population that I’m struggling to imagine how and why this would be instigated. Still, we have seen that as many as 1/3 of individuals who are diagnosed with T1D as adults are initially misdiagnosed with type 2 diabetes. So that might lend weight to the argument in support of eventual global, or at least broader, testing.”
Anita Swamy: “I think that’s a really good point. We see a lot of those just because of their age, and those people really suffer those first few months.”
Marissa Town: “I think about the adults too, who are diagnosed with T1D, at age 50 or something. If there were a screening that you could do that told you, ‘Hey, I may have [this disease], and these are the symptoms that I need to watch for so that I don’t end up in an intensive care unit.’ I think it would save a ton of lives.”
Where can we as a T1D community make an impact in educating healthcare providers on T1D screening/staging?
Anita Swamy: “I would say medical school/medical residency, because right now the diagnosis of T1D is a fasting blood glucose of 126, 200 during an OGTT, or an A1C of 6.5. And well, no, it’s really not. We have to consider now adding [the staging and monitoring] that we never teach.”
Marissa Town: “Screening guidelines are needed, for both families and providers. It is something that doesn’t [to my knowledge] exist yet….The sooner that we can get that kind of stuff in order, the better and easier [screening] is going to be. [T1D] is like a major burden on families, so let’s do everything we (T1D healthcare providers, policymakers, patient advocates) can to lighten that burden.”
What role, if any, do you think patient advocacy groups play in the education of parents/caregivers/patients? How do you view their role in screening uptake and education?
Marissa Town: “I think we (as a patient advocacy organization) try to advocate for people to have the choice to do what they want with their diabetes, but [the education] is not as heavy of a weight if it comes from a patient organization. I think it is important to engage with advocacy groups, but I think it should come from the [healthcare] professional side first.”
Anita Swamy: “I think hitting the doctors and educators first [is critical] … We do the JDRF Type 1 Nations, right, and ~500 people come out per year. It’s awesome and a nice way to reach the families about other topics.”
Conclusion
Barriers to T1D screening exist, even between professionals working in the same field. Discrepancies on approaches to screening exist. Alignment on key aspects of T1D screening amongst experts would be beneficial to healthcare providers and patients. Guidelines and suggestions for clinical guidance on who, how, and when to screen are desperately needed. Implementing the guidelines may remove barriers faced by healthcare professionals and patients and may help to relieve some of the burdens placed on patients and healthcare providers. Identifying the barriers to T1D autoantibody screening and developing practical solutions and steps is critical to overcome these obstacles.
Conflict of Interest
AS, MT, and WP have participated as consultants for Provention Bio. No compensation was received for the creation of this manuscript.
Author Contributions
AS, MT, and WP equally contributed to the formation of interview questions and the writing of this manuscript. The authors are solely responsible for the content of this manuscript.
Acknowledgments
Jacquelyn Brown, PhD and Laura Knecht, MD of Provention Bio were active participants in the discussions during author interviews and provided editorial assistance for the creation of the manuscript.
Funding
No financial compensation was provided to the authors. JB and LK are employees of Provention Bio.
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