The type 1 diabetes (T1D) community has collectively identified a need for general population autoantibody screening. In response, a report by Ross and Altimus, Type 1 Diabetes Autoantibody Screening: A Roadmap for Pediatric Policy Implementation, was generated from the Milken Institute’s Center for Strategic Philanthropy (CSP), and funded by The Leona M. and Harry B. Helmsley Charitable Trust.

The CSP conducted an in-depth analysis of preventive policies, T1D autoantibody screening, and familial screening. This resulted in a comprehensive report illustrating the importance of building an evidence base for pediatric, general population testing for T1D autoantibodies, and blood-based biomarkers that precede clinical diabetes.

Without general population testing, the majority of people aren’t identified prior to diagnosis, as approximately 85% of people living with T1D have no family history of the autoimmune disease.

At present, there are no supportive recommendations or policies surrounding clinical care for this testing, nor approved therapies focused on preventing or delaying T1D (teplizumab is currently under FDA review) — or curing it. The American Diabetes Association (ADA) currently recommends screening of family members in the context of research and clinical trials.

In order to advance this research, the identification of more autobantibody-positive individuals is essential. By providing an implementation roadmap with goals, objectives, and actionable steps, this report will help the T1D community to reach short and long-term goals, together.

In this interview with Anne Koralova, Ph.D., Program Officer for the Helmsley Charitable Trust’s Type 1 Diabetes Program, we discuss the Milken report and the future of autoantibody screening for T1D.

Please tell T1D Exchange readers about yourself.

I’m a Program Officer in the Helmsley T1D Program and I work in our prevention portfolio.

What do you think the largest hurdle is for general population screening?

I think the largest hurdle is the general public’s understanding of what T1D is, the burden, the difficulty of the disease, even how it compares to type 2 diabetes. There’s so little understanding of the disease outside of the T1D community. And this is a problem, because if you don’t see the burden, why would you care about preventing it and screening for it?

What is unique about this report?

What’s really great about this report is the bringing together of different types of information. On one side there’s the clinical research (state of the field), while on the other, there’s policy. This is so important, because for policy to change, you need data and evidence.

This hasn’t been done before [for islet autoantibody screening], and so from the report point of view, this is what’s really impactful. It’s bringing different perspectives about policy and clinical research together — with tangible recommendations on how to move forward.

Can you talk about the timeline associated with these changes?

To make significant changes in these spaces, it takes a long time. Will we see broader screening before 10 years? Yes, I believe so. But will we see comprehensive (everyone’s getting it) screening in 10 years? Honestly, 10 years seems slightly optimistic because of everything that needs to go into it. We’ll see wider screening from a piecemeal point of view — and as decisions are made about teplizumab approval and availability, it could possibly accelerate it, but I don’t think much faster.

Has an age for screening been determined?

This is a tricky question, because you have to balance practical, feasible screening, versus what is known scientifically about disease progression. “Magic times” to screen aren’t known, but more data is being generated in this area. There are screening ages that might be capable of catching more positive individuals, but this isn’t agreed upon by everyone.

Can you discuss the step-wise approach to screening?

A stepwise approach would be establishing recommendations based on familial screening being the standard of care first, and secondarily expanding to the general population. There’s a little bit of a tension with that, because it makes it seem that only family members should be screened, but most people developing diabetes are outside of the first- or second-degree familial relationship.

However, starting with family members is good, because they’re at high-risk, so they’re going to benefit more on a population level. We can also generate data from familial screening that can then be applied to the general population, from an outcomes point of view.

Do you have any additional thoughts about this report?

It’s important to remember that, depending on the study, 30 to 60% of children who develop T1D are diagnosed in DKA, and studies correlate DKA at the time of diagnosis with worse long-term glycemic control and outcomes.

For us, the screening is about providing the best clinical care. Whether that’s therapeutic (giving a drug), or not, we believe that identifying people in the early stages of disease, giving them the right support, education, monitoring — and the avoidance of DKA — are valuable treatments.

Future therapies that can delay disease onset will be game changing.

We believe that this is a really important topic, so you will probably see additional work spring off of this report. This is such a special moment in time, that we want to capture the momentum and keep going with it. As a program, we’re very committed to this area and we believe that this work will continue.