JDRF launches mass screening program for early detection of type 1 diabetes
JDRF has launched the first mass screening program for early detection of type 1 diabetes called T1Detect, part of a larger effort to prevent disease complications like diabetic ketoacidosis and speed the pace of research for a cure.
Detecting type 1 diabetes before symptoms occur is possible through a blood test when people have two or more diabetes-related autoantibodies and glucose levels have become abnormal. Research shows 75% people at this stage will become insulin-dependent within 5 years, according to JDRF. Their lifetime risk for clinical disease approaches 100%.
Approximately 85% of people with type 1 diabetes have no family history.
The screening program, supported in part by Provention Bio, Med-IQ, Nuvera Life Science Consulting and Enable Biosciences, launched Tuesday.
Healio spoke with Sanjoy Dutta, PhD, vice president of research for JDRF, about how a home-based test works, screening for prevention of DKA and the continued search for a cure for type 1 diabetes.
Why is there a need for a type 1 diabetes screening test?
Dutta: There are two main reasons. There is an urgent need to accelerate the development of disease-modifying therapies. By that we mean therapies that could completely change the course of type 1 diabetes — prevent it for those at risk or cure it for those recently diagnosed or who had longer disease duration. One of the keys to progress in that area is the availability of people to participate in clinical trials. That is impinging on our mission progress.
The second is research funded by JDRF, the NIH, Helmsley Charitable Trust and others clearly demonstrates that screening is beneficial for people even in the absence of an approved disease-modifying therapy. The number varies, but data suggest that, through screening, the rate of diabetic ketoacidosis at diagnosis can be reduced from 60% to 3% or 1%. The danger of DKA that one experiences at the hospital at diagnosis falls dramatically. That is a big win. Screening has also demonstrated that it provides people the time to prepare for the diagnosis and studies also suggest long-term HbA1c benefits with screening when you control for other variables.
Right now, most screening is family-based. Family members of people with type 1 diabetes, we know, are at a heightened risk, so this is a reasonable thing to do. However, we also know that 85% to 90% of the people who go on to develop type 1 diabetes do not have a known family member with the disease. This means we are only capturing around 10% to 15% of the people at risk.
How did the partnership with Provention Bio come about?
Dutta: Provention Bio recently acquired the humanized anti-CD3 monoclonal antibody teplizumab, which showed amazing results for type 1 diabetes, and they have publicly stated that they have completed their submission to FDA for review. Probably sometime in 2021, the FDA will render its decision on that therapy. If this drug becomes available, which we all think is amazing, how do you identify who to give these drugs to? What age? How do you distribute it? So, there is a need here. We are the largest organization for type 1 research and we have an incredible community of researchers and volunteers, so we are in a position to have the biggest reach that another pharma company may not. There are also restrictions on advocating for your own drug. We can spread the word that, you need to get screened, and we may have a therapy now that can potentially prevent or delay the onset of disease. This partnership came to fill a gap that cannot be filled by any one company.
How does this work, and how can a person obtain an at-home test?
Dutta: We piloted this among some of our constituents here, and it worked very well. It is very user friendly. This blood test detects autoantibodies in the blood that mean you are at an early stage of type 1 diabetes and are very likely to become insulin-dependent in the future. With a finger prick, a person provides a blood sample and mails them back to the lab. The antibody results, with explanations of what they mean and recommended next steps, are provided in a couple weeks. During COVID-19, this is the best option. Going forward, we may look into deploying this test to clinics.
Kits cost $55, with the option to order a subsidized kit if you are unable to afford the full price.
What is JDRF doing to spread the word and educate?
Dutta: A lot, and I’m sure we can do a lot more. Community engagement, clinician education, patient education — we have several modules under this “T1Detect” umbrella. For consumers, it is less of a research question and more an engagement and education question. How do you test? If positive, where do you go and what do you do? What kind of care do you seek? Many in JDRF are working on this. We have a partnership with Beyond Type 1 and will work with Med-IQ. We complement each other’s strengths and each other’s communities. There is an urgency to this, and we need to roll this out now. Waiting for perfection will be the enemy of the good that we can do now.
There has been a request for this from the patient community and manufacturers, and that is the main driver behind this. People are asking for this. They want to test. This is the role JDRF has always played.
JDRF. T1Detect: Learn why you should be screened. Available at: https://www.jdrf.org/t1d-resources/t1detect/. Accessed Dec. 10, 2020.
For more information:
Sanjoy Dutta, PhD, can be reached at email@example.com.