The American Diabetes Association’s 84th Scientific Sessions is here! Scientists will present the latest type 1 diabetes (T1D) research, from early detection to glucose control to complications, all with the goal of improving lives for the T1D community.

  1. In November 2022, the FDA approved Tzield™ (teplizumab-mzwv) for use in delaying the onset of clinical T1D. With the availability of a treatment option for people with Stage 2 T1D, the field has changed its outlook on delay and prevention and navigating pediatric T1D, especially in the early stages. Annette-Gabriele Ziegler, M.D., presented on several screening programs in Europe, including Fr1da, which has screened 200,000+ pediatric participants and found that it significantly reduces DKA onset at clinical diagnosis, and GPPAD, which identifies infants with an elevated genetic risk of developing T1D and enrolls them in primary prevention clinical trials. Andrea Steck, M.D., highlighted the value of CGM-based metrics in evaluating T1D risk and R. Brett McQueen, Ph.D., discussed the economics of early detection.

At-risk, or Stage 2 T1D, means that a person exhibited 2+ T1D-related autoantibodies—antibodies against one’s own self—and their blood glucose is starting to be abnormal, but they are not yet insulin dependent. When someone becomes insulin-dependent, they are in stage 3 T1D.

You have heard Breakthrough T1D say it before: Build a global universal type 1 diabetes (T1D) early detection program. This will reduce diabetes ketoacidosis (DKA)—a life-threatening complication—at diagnosis and identify autoantibody-positive individuals to take part in preventive treatment or clinical trials. 

Having 2 or more persistent T1D autoantibodies—antibodies that are directed toward your own body—means you have an almost 100 percent chance of developing T1D in your lifetime. 

But there have been no monitoring guidelines for individuals who tested positive for T1D autoantibodies through early detection. Until now.

Consensus guidance

Breakthrough T1D spearheaded an effort to develop the first internationally agreed-upon guidance for anyone who tests positive for T1D autoantibodies, co-published today in the journals Diabetes Care and Diabetologia.  

These provide guidelines for monitoring children, adolescents, and adults who test positive for T1D autoantibodies, along with recommended monitoring frequencies and actions for healthcare professionals when the risk of progression toward symptomatic T1D is high.  

The guidance also includes recommendations for educational and psychosocial support for positive T1D antibody individuals, including their families and caregivers, and may also lead to primary care doctors screening more frequently since there is actionable monitoring guidance available to them.   

For the first time, individuals, families, and healthcare professionals have concrete next steps to monitor early stage T1D progression and catch the symptoms early to prevent DKA.   

This guidance was developed in conjunction with over 60 international experts, representing 10 countries and endorsed by 11 national and international societies. 

As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with the condition better while driving toward cures. We won’t stop until the condition is a thing of the past.

That means powering research to cure, prevent, and better treat T1D and its complications and ensuring that the entire T1D community has access to the tools they need to thrive.

Explore our research.

Breakthroughs past, present, and future

For more than 50 years, Breakthrough T1D has played a pivotal role in nearly every major T1D breakthrough—from how HbA1c came to be more than 40 years ago to recent advancements like advanced T1D management devices, such as artificial pancreas (AP)/automated insulin delivery (AID) systems. Our work has also ensured that people have access to these advances.

Let’s have a look at some of the biggest breakthroughs we’ve advanced that are improving lives right now and those that promise to improve lives in the future.

The first disease-modifying therapy for T1D

In 2022, the FDA approved Tzield™ (teplizumab-mzwv) for use in delaying the onset of clinical T1D. This was the first disease-modifying therapy (DMT) for T1D to be approved. These are treatments that can slow, halt, or reverse the course of a condition. It took decades of Breakthrough T1D research for Tzield to reach approval.

Beginning with basic research by Kevan Herold, M.D., in the 1980s to preclinical and early clinical trials to a strategic investment from the T1D Fund: A Breakthrough T1D Venture that brought Provention Bio—the company that launched Tzield—into T1D for the first time, in 2017.

“The story with the clinical use of teplizumab began with a Breakthrough T1D grant to support a trial in patients with new-onset type 1 diabetes more than two decades ago. The success of this initial study planted a seed that led to further studies and support from the NIH.”

Kevan Herold, M.D.
Yale School of Medicine

But there’s a personal story, too.

Andy Drechsler and his wife Moira are the parents of four children; three of them have T1D. They have been involved with Breakthrough T1D since their son was diagnosed at the age of 22 months in 2005.

Andy’s professional life intersected with his personal life when he helped start Provention Bio in 2017.

“Everyone living with T1D provides us with great inspiration. We also appreciate the parents and caregivers of T1Ds. We are so happy to see the improvements in pumps and CGMs for those living with T1D. We are also thrilled to see therapies to delay the onset. Ultimately, we are confident that therapies will allow many to live without T1D someday.”

Andy Drechsler
Board of Directors President
Breakthrough T1D New Jersey Metro and Rockland County Chapter

We are moving ever closer to a world without this disease. Tzield is one gigantic step along the way, and others are right behind it. Read about the other disease-modifying therapies in our pipeline to learn about the drugs that could become the “next Tzield.”

T1D management devices—decades in the making

For 20+ years, Breakthrough T1D spearheaded efforts to develop artificial pancreas (AP) systems—also called automated insulin delivery (AID) systems. We would go on to fund more than 150 grants, including 50+ clinical trials, funded by us and backed by our Artificial Pancreas Consortium, to make the artificial pancreas system a reality.

Thanks to Breakthrough T1D research and advocacy efforts, approximately 15 FDA-approved T1D management devices are on the market today—more than half of them AP systems and the remainder, advanced CGMs and insulin pumps.

Read about the different AID systems that the U.S. Food and Druge Administration has approved in recent years.

“Witnessing the progression of T1D breakthroughs over the years has been nothing short of remarkable. When I first started insulin injections, it was a cumbersome routine, requiring multiple injections a day. Today, thanks to advancements in insulin pump technology, managing T1D has become more streamlined and efficient, improving my quality of life.” 

Princess Padmaja Kumari Parmar
Breakthrough T1D Global Ambassador

Early detection empowers families, helps advance research

T1D develops in stages over time. Early detection identifies people who have early-stage T1D, but no symptoms, by a simple blood test. It looks for markers in their blood called autoantibodies. These autoantibodies signal that the body’s immune system is attacking the insulin-producing cells in the pancreas.

Autoantibodies also have value in identifying individuals who would later develop T1D, providing a new staging for presymptomatic T1D. The presence of two or more means that your lifetime risk of getting T1D is nearly 100 percent.

Early detection gives families time to plan and prepare before the onset of the condition, prevents life-threatening complications and hospitalization at the onset of symptoms. Critically, it also identifies at-risk people who can take advantage of preventive therapies—including disease-modifying therapies such as Tzield—or participate in clinical trials for T1D therapies being developed.

NFL Super Bowl Champion Orlando Brown, Jr., knows all too well how dramatically T1D can impact families, as his late father and his younger brother were both diagnosed with T1D.

In his role as Breakthrough T1D ambassador, the Cincinnati Bengals offensive tackle strives to educate people about T1D and the importance of T1D early detection and research. He also uses his platform to advocate for insulin affordability and policies like the Special Diabetes Program (SDP). Last summer, he was one of 10 Celebrity Role Models at Breakthrough T1D Children’s Congress.

Learn about our program, Breakthrough T1D Early Detection.

“The sudden loss of my father to diabetic ketoacidosis and my younger brother’s type 1 diabetes diagnosis at just 11 years old brought us face-to-face with uncertainty and the stigmas surrounding this condition. However, as we learned about diabetes devices and treatments to help manage the disease, we discovered a renewed sense of peace and hope. With more research, we believe we can ultimately end this disease. Knowledge is power and I’m sharing my family’s story to educate and inspire others who are living with type 1 diabetes.” 

Orlando Brown, Jr.
NFL Super Bowl Champion
Breakthrough T1D Ambassador

Breakthrough in progress: stem cell-derived replacement therapies

Cell therapies replace beta cells in the bodies of people with T1D so that they can again produce their own insulin​.

Biotech powerhouse Vertex Pharmaceuticals is making major headway in its goal of developing stem cell-derived replacement therapies for T1D. This work being advanced by Vertex has been supported by Breakthrough T1D for decades.

Vertex launched its clinical trial of VX-880, a stem cell-derived islet therapy in T1D for individuals with hypoglycemia unawareness, in combination with immunosuppressive therapy to protect the cells from rejection. Several people who have received VX-880 have been able to stop taking insulin.

This work was pioneered by Doug Melton, Ph.D., whose years of Breakthrough T1D-funded research led to successfully transforming stem cells into beta cells in 2014. A catalytic investment from the T1D Fund in Semma Therapeutics—the biotech company Melton founded to develop a stem cell-derived islet therapy for T1D—was followed years later by Vertex acquiring Semma. Vertex also acquired ViaCyte, which like Semma, had received support from Breakthrough T1D and the T1D Fund for its cell therapies research.

See the timeline of Breakthrough T1D’s support of stem cell-derived islet replacement therapies.

Douglas Melton Beta Cells

“My lab research has been for more than a decade or two, trying to cure type 1 diabetes. That might sound like an overly ambitious project, but I believe it’s a solvable problem. Our lab worked for years to figure out how to turn stem cells into functional beta cells. We can now make billions of functional beta cells.”

Doug Melton, Ph.D.
Vertex Pharmaceuticals Research Scholar

We are Breakthrough T1D

Breakthrough T1D is knocking on the door of something big. Giant leaps are happening nearly every day. You have gotten us to where we are today—and you can help us get to the finish line faster. So that you, your loved ones, and people everywhere can enjoy a world free from the burden of T1D. A world where people don’t have to manage their diabetes—don’t take insulin, don’t have blood sugar highs and lows, and don’t develop complications. With your ongoing support, we won’t stop until this condition is a thing of the past.  

Learn More About Our New Brand.

Learn More About Our Organization.

When Breakthrough T1D was founded in 1970, there were no types of diabetes. There was no type 1, no type 2, no gestational (which, as we now know, happens when you are pregnant). It was all diabetes.

Until 1974. Two teams showed—for the first time—that insulin-dependent diabetes is associated with the development of antibodies directed against insulin-producing beta cells in the pancreas.1,2 This was instrumental in establishing type 1 diabetes (T1D) as an autoimmune disease.

Using this, investigators were able to:

1. Describe the presence of more antibodies, besides the islet cell antibodies, that were associated with type 1 diabetes. There are now 5 antibodies connected with the disease.

 What’s more, studies have shown that T1D begins well before its symptoms appear—and it includes the presence of 2 or more T1D-specific antibodies. This allowed us to conduct clinical trials before the presence of symptoms, to prevent or delay the progression to clinical onset of the disease.

2. Refine the tests for T1D-related antibodies, for more widespread study. This led to TrialNet—an international NIH-funded and Breakthrough T1D-supported network of leading academic institutions, endocrinologists, physicians, scientists, and healthcare teams dedicated to finding cures for T1D—who began its Pathway to Prevention study in 2004. This study identifies people at risk for T1D with the aim to conduct clinical trials to stop the disease.

3. Conduct clinical trials targeting several immune pathways and mechanisms, including teplizumab—a drug that blocks CD3, a blood marker that helps activate immune cells. In a clinical trial conducted by TrialNet, it was the first study to significantly delay the onset of T1D, for nearly 3 years, in individuals at-risk of developing the disease.

Recently, Breakthrough T1D also launched a community-based education and awareness program to expand screening to the general population. The program’s aim is to make people understand what type 1 diabetes is, how screening is advantageous to the public, how they can be involved, and what to do if you are positive for T1D-specific antibodies.

Learn more about the Breakthrough T1D Early Detection Program.

  1. Bottazzo GF, Florin-Christensen A, Doniach D. Islet-cell antibodies in diabetes mellitus with autoimmune polyendocrine deficiencies. Lancet. 1974 Nov 30; 2 (7892): 1279-83. PMID: 4139522.
  2. MacCuish AC, Irvine WJ, Barnes EW, Duncan LJ. Antibodies to pancreatic islet cells in insulin-dependent diabetics with coexistent autoimmune disease. Lancet. 1974 Dec 28; 2 (7896): 1529-31. PMID: 4140978.