It was 2015—five years ago—that three organizations (BreakthroughT1D, the Endocrine Society and the American Diabetes Association) published a statement urging the adoption of a staging system of type 1 diabetes (T1D) that uses islet autoantibodies as biomarkers. (Biomarkers, in this sense, are indicators that a person is developing T1D but is still without symptoms.) It was today that there was some great news. The European Medicines Agency (EMA) presented a letter of support to the Critical Path Institute’s T1D Consortium—who Breakthrough T1D and like-minded organizations have partnered with—to facilitate the development and validation of autoantibodies for T1D for regulatory use. This is a big win for therapy developers and the T1D community.

Autoantibodies are antibodies against one’s own proteins. In T1D, there are three stages:
Stage 1: 2+ autoantibodies, blood glucose is normal, no symptoms
Stage 2: 2+ autoantibodies, blood glucose is abnormal, no symptoms
Stage 3: 2+ autoantibodies, blood glucose is abnormal, clinical symptoms appear

“This letter of support from EMA is a critical step in accelerating therapies that can, hopefully, delay and, ultimately, prevent T1D from developing,” says Jessica Dunne, Ph.D., senior director at Breakthrough T1D and co-director of the T1D Consortium. “It shows collaboration between regulators and researchers working together to get therapies into the hands of the type 1 diabetes community as quickly as possible.”

The ability to screen for subjects with early stages of T1D prior to the appearance of clinical symptoms is vital to the clinical trials investigating delaying, and ultimately preventing, symptomatic T1D. The autoantibodies may be used to identify subjects in early stages of the disease with a high risk of disease progression to symptomatic diabetes to enroll in clinical trials. Ultimately, the prevention of the appearance of these autoantibodies could possibly be used as a marker for prevention of T1D in clinical trials.

This regulatory endorsement will help provide sponsors with confidence to use islet autoantibodies in the optimization of clinical trials evaluating novel therapies focused on the delay and/or prevention of T1D.

The Letter of Support can be found on the EMA website or on the T1D Consortium website.

TrialNet—an international Breakthrough T1D-supported network of leading academic institutions, endocrinologists, physicians, scientists and healthcare teams dedicated to finding cures for type 1 diabetes (T1D)—has a new in-home test kit that makes screening far more easy and convenient. And FedEx will come pick it up, at no cost to you!

If you have a relative with T1D, you can detect your risk of developing this disease today through the TrialNet Pathway to Prevention study. Here’s how:

• If you are eligible (the eligibility requirements are below), go to trialnet.org/participate to complete the online consent form
• If you are in the U.S., order an in-home test kit (if you’re outside of the U.S., a study coordinator will contact you with more information)
• When it arrives in the mail, collect about 10 drops of blood using a finger prick
• Place it in the collection envelope
• Call FedEx at 1-800-463-3339 to schedule a pickup, or go online to FedEx.com, where you can schedule a one-time pickup or find a drop-off location (this needs to be done within 24 hours of the blood collection)

That’s all!

Results are typically reported in 4-6 weeks. However, due to COVID-19, results may be delayed. If your results show you are in the early stages of T1D (defined as testing positive for T1D-related autoantibodies), there may be an opportunity to participate in a T1D prevention trial.

TrialNet screening can sometimes detect T1D years before symptoms occur. Detect your risk today.

On April 29 at 6:30pm ET, Carla Greenbaum, M.D., chair of TrialNet and a member of Breakthrough T1D Speaker’s Bureau, will take part in a Facebook Live event, sponsored by Breakthrough T1D, to speak about research in the time of COVID-19—what TrialNet is up to during this time and answering your questions about these investigations.

Eligibility Criteria

You qualify for free screening if:

• you are between the ages of 2.5 and 45, and have a parent, brother/sister or child with T1D
  OR
  you are between the ages of 2.5 and 20 and have an aunt/uncle, cousin, grandparent, niece/nephew or half-brother/sister with T1D
  AND
  you have not been diagnosed with diabetes.

If you have questions, contact TrialNet at 1-800-425-8361 or email info@trialnet.org.

Sometimes, the funding that Breakthrough T1D can provide for researchers is exactly the invitation they need to get into the field of type 1 diabetes (T1D) research. Other times, sustained grants are the critical boost that someone with more experience needs in order to branch out and establish his or her own lab. Creating and sustaining a passionate pipeline of early-career researchers is one of Breakthrough T1D’s ever-present goals.

• Manoj Gupta, Ph.D., is a postdoctoral fellow at the Joslin Diabetes Center. He’s comparing samples from people who have had T1D for more than 15 years. By studying proteins to determine why some people rapidly develop kidney complications and others don’t, Dr. Gupta may help develop therapies that benefit people with kidney complications.
• Chandrabali Bhattacharya, Ph.D., is a postdoctoral fellow at the Massachusetts Institute of Technology. She’s working on developing sensors that can detect glucose quickly. These smart insulin systems would be able to respond right away to elevated glucose levels, release the right amount of insulin and stop when glucose is normal.
• Monika Niewczas, M.D., Ph.D., M.P.H., is an assistant professor at Harvard Medical School and assistant investigator at Joslin Diabetes Center. Dr. Niewczas is working to understand how the body develops diabetic kidney complications. She then plans to translate that research into therapies that will help individuals with the disease.
• Kacey Prentice, Ph.D., is a postdoctoral fellow at the Harvard T.H. Chan School of Public Health. Dr. Prentice is working to better understand beta cell function, so that she can help preserve beta cells and prevent people from developing T1D to begin with.
• Elad Sintov, Ph.D., is a postdoctoral fellow at Harvard University. Dr. Sintov is producing beta cells from stem cells. Now he is trying to figure out ways to genetically modify those cells so that a transplant recipient’s immune system will not notice them and mount an attack.

Please join us for an inside look, as we present the eighth video in our Inside the Lab series. Find out how a few key early-career researchers are using Breakthrough T1D support to push forward a few key lines of research.

If you haven’t seen the other featured videos in this series already, don’t miss out. See how scientists are collaborating to expedite the process of finding cures and improving lives:

• Boston: A Global Leader of Type 1 Diabetes Research is an overview of the leading scientists and institutions for T1D investigations in Boston and Breakthrough T1D’s role in shaping and supporting this research.
• Beta Cell Replacement Research in Boston looks at the collaborations and skills that researchers in Boston are using to tackle the complex task of replacing beta cells in people with T1D.
• Beta Cell Regeneration Research in Boston asks: Can we internally regenerate and protect existing beta cells, and therefore find cures for T1D?
• Prevention Research in Boston shows experts that are working to delay T1D, or stop it before it starts.
• Immune Therapy Research in Boston asks: Can we redirect the body’s immune response to find cures for type 1 diabetes?
• Kidney Complications Research in Boston looks at how we are working to prevent the predictable: kidney disease for 1 in 4 people who have T1D.
• Eye Complications Research in Boston shows how we can used improved technology and data processing to more quickly determine solutions for diabetic eye disease.

Funding early-career researchers is one of Breakthrough T1D’s best opportunities to increase our knowledge of the disease and find cures for T1D. Please consider donating today, and we’ll turn type 1 into type none, with your support.

Universal screening for type 1 diabetes (T1D) is a priority for Breakthrough T1D, but the cost versus benefits remain unclear. Now, a large-scale population study in Bavaria, Germany, headed by Breakthrough T1D-funded Anette-Gabriele Ziegler, M.D., Ph.D., has a clue. The Fr1da study of nearly 100,000 children suggests that screening for autoantibodies—antibodies that are directed toward your own body—can reduce the progression from pre–symptomatic T1D to life-threatening diabetic ketoacidosis (DKA), by a lot.

DKA is a life-threatening complication due to a shortage of insulin, causing symptoms like dehydration, nausea and vomiting, confusion and difficulty breathing. If it’s not caught early, it can be fatal. DKA requires treatment in the hospital, and is associated with poor long-term blood-sugar control. 

The Fr1da Study 

Of the 90,632 children between the ages of 2 and 5 years old, 280 had pre-symptomatic T1D, and only two of those progressed to DKA. That’s less than 1 percent! Considering that the prevalence of DKA in unscreened children is approximately 20 percent in Germany and 40 to 60 percent in the United States, this is a big deal! 

The significance of this is dramatic. DKA at diagnosis of T1D in children, unfortunately, predicts poor long-term glycemic control. That correlates to a greater risk of complications.  

What about the costs? The screening costs were kept low by using a relatively inexpensive and sensitive prescreening method, which could exclude a vast majority of children from more expensive measurements. 

How about the parents of children with pre–symptomatic T1D? Did they experience any distress when their children were diagnosed? It turns out: Yes, however, this declined within one year, and was low to moderate in the majority of families, suggesting that it is unlikely to lead to a level of distress observed in parents of children diagnosed with clinical T1D. 

In summary, Fr1da is the first study to introduce preschool screenings for T1D in the general population, and the success of the study shows that large-scale screenings are possible and that there are large benefits to early diagnosis of T1D.  

What’s next? Moving forward, the researchers will perform a cost-benefit analysis of the screenings, as part of the evidence to moving screening to the public health sector as standard of care. Furthermore, we can enroll people with autoantibodies in clinical trials aimed at halting or delaying the progression to T1D. To learn more about our screening efforts, go here.