From March 15–18, more than 200 passionate, motivated Breakthrough T1D Advocates from all 50 states convened in Washington, D.C., for Breakthrough T1D 2026 Government Day.
Government Day remains one of Breakthrough T1D’s most impactful ways to effect change. By bringing the lived type 1 diabetes (T1D) experience directly to policymakers, we are accelerating progress toward our vision of a world without T1D. Guests also enjoyed networking opportunities, briefings from our Research, Advocacy, and Medical Affairs teams, and a spirited volunteer recognition celebrating our successes of the last year.
Over the course of a few days, our advocates held nearly 500 meetings with Members of Congress and their staff in the U.S. House and Senate, sharing their personal stories of life with T1D, championing our top legislative priorities, and doing all they could to ensure that the collective voice of the T1D community was heard loud and clear on Capitol Hill.
Breakthrough T1D Advocates had a few specific asks for Congress. These represent our top legislative priorities, which will have the biggest impact on our ability to achieve our mission.
It should be no surprise that the Special Diabetes Program (SDP) is first and foremost.
The Special Diabetes Program (SDP) remains pivotal to our ability to realize cures. Since its creation in 1997, it has contributed nearly $3.8 billion to T1D research. This investment has paid huge dividends, generating breakthroughs and delivering an estimated $50 billion in Federal healthcare savings, just from the use of devices alone.
In February 2026, Congress passed an extension of the SDP through December 31, 2026, along with an increase in annual funding from $160 million to $200 million. Advocates expressed deep gratitude for this progress while emphasizing the urgent need for long-term renewal.
Progress toward cures is impossible without funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA)—essential agencies driving the development of new therapies, prevention strategies, and cures. Advocates asked Congress to support strong funding for these agencies to ensure our critical progress continues.
Cell therapies are a matter of when, not if. Today, there are more than a dozen cell therapies in clinical trials. Our advocates highlighted the transformative potential of these approaches to cure T1D, and called for policies and funding to support faster clinical trials, scalable manufacturing, and future access to these life-changing therapies.
People with T1D cannot live without access to insulin. It’s that simple. While there has been marked progress of insulin affordability in the past few years, including the $35 monthly cap for those on Medicare, there is still work to be done.
Advocates continued to push for meaningful insulin affordability reforms. They are calling on Congress to expand affordability and access to those with commercial insurance and the uninsured through forthcoming legislation.
One of the highlights of Government Day was the presentation of the Mary Tyler Moore Award to Princess Padmaja Kumari Parmar of Udaipur, India.
Princess Padmaja was recognized for her extraordinary leadership and dedication to improving the lives of people with T1D. Through her advocacy and global engagement, she has helped elevate awareness, drive progress, and inspire action across the international diabetes community—embodying the spirit and legacy of Mary Tyler Moore.
Mary Tyler Moore’s husband, Dr. S. Robert Levine, shared remarks highlighting Mary’s enduring legacy, and CEO Aaron Kowalski, Ph.D, presented the award to the Princess.
Breakthrough T1D was also proud to honor Senator Jeanne Shaheen (NH) with the Congressional Legacy Award in recognition of her decades of leadership and unwavering commitment to the T1D community. Here’s a brief summary of her accomplishments:
Across her years of service, Senator Shaheen has consistently ensured that the T1D community is seen, heard, and prioritized in Congress. She is one of the greatest T1D Congressional champions to date.
Government Day once again demonstrated the power of our stories. Every person impacted by T1D has a story to tell about how they live with this disease, what it’s like, and how Congress can help. Every meeting in which those stories were told made a crucial connection that will bring us closer to a world without T1D.
Breakthrough T1D is tremendously thankful to the hundreds of advocates who came to Washington, D.C., to make this event possible—and for making it impactful.
This was also our last year using the name “Government Day.” After all, it’s a several-day event! Next year, we’ll be back as “Breakthrough T1D On the Hill” — a name that better represents our organization and the event.
Want to use your voice to power progress on our path to cures? Become an Breakthrough T1D Advocate today.
Nearly 3 years after Breakthrough T1D joined forces with Civica, a non-profit pharmaceutical company, its first insulin is now available for purchase at pharmacies across the country.
Check out our story from October that highlights the years of partnership between Civica and Breakthrough T1D that made today a reality.
We worked with our partners at Civica to answer some of the most common questions you may have about this insulin and where to get it.
Civica insulin glargine-yfgn. It will have a “CalRx” label in California.
Civica insulin glargine-yfgn is a long-acting insulin interchangeable with Lantus.
Broad availability is expected at U.S. pharmacies as production increases. Ask your pharmacist.
If you have health insurance:
If you are paying cash:
For Californians:
Max recommended price: $55 per box of five pens. Your cost may be lower depending on insurance. This is the lowest list price for long-acting insulin, without hidden rebates or markups.
Yes. If you already have a prescription for insulin glargine (e.g., Lantus), you do not need a new one because Civica insulin glargine-yfgn is interchangeable. Confirm with your provider and pharmacist.
No. Pens are sold in boxes of five pre-filled pens.
Yes, but you don’t need insurance to buy it. Out-of-pocket costs could be as low as $0 depending on your plan.
You can learn more about Civica insulin at CivicaInsulin.org.
Every new medical device, therapy, treatment, and drug—including those for type 1 diabetes (T1D)—goes through the drug development pipeline. Getting a new therapy or device from the earliest stages of research eventually into the hands of people with T1D is a complicated process. Science takes time (from years to decades!), money (from hundreds of millions to billions!), and brainpower (lots and lots of brilliant scientists, doctors, researchers, and more)—and lots of it.
That’s what drives us and our work in the pipeline: people with T1D doing better.
This process is complex, to say the least. There are safety checks at every step of the way. Data are scrutinized, and preclinical and clinical testing must meet ethical standards. In fact, many new drugs and devices don’t make it very far in the pipeline—and those that do take a long time to get there.
Breakthrough T1D is unique in that we work across the entire pipeline—from start to finish—for every promising therapy or device that we invest in. Between Research, Advocacy, and Medical Affairs, we work at every single step to accelerate progress and get new treatments to people with T1D faster than ever.
That’s our value proposition. That’s what makes supporting us different than supporting an individual researcher, or a university, or a company.
Let’s dive a little deeper into the pipeline—and how we’re turbocharging it.
By Breakthrough T1D
Total T1D research support, including by Breakthrough T1D
By the Special Diabetes Program
In healthcare
Estimated time it takes a new drug to get to the clinic
Estimated total cost to bring a new drug from discovery research to the clinic
Estimated time it takes a new medical device to get to the clinic
Estimated total cost to bring a new medical device from discovery research to the clinic
Automated insulin delivery systems vs. artificial pancreas systems
At the very beginning, these devices were called artificial pancreas (AP) systems. Today, they are called automated insulin delivery (AID) systems. We’ll be referring to them as AID systems going forward.
The amount of money Breakthrough T1D spent on AID system-related research from 2005 to 2024
The amount of time it took for next-generation AID systems to go from discovery research to clinical adoption after Breakthrough T1D became involved
Total investment in AID systems from all stakeholders
The amount of time it took for AID systems to become a reality, starting with the first experimental AP system in 1964
Breakthrough T1D x AID systems
Breakthrough T1D has played a significant role in the evolution of AID systems. Doug Lowenstein, a long-time Breakthrough T1D volunteer and supporter, detailed the history of AID systems from the very beginning, and how we accelerated progress at every step of the way.
It’s the early 2000s. I’m a new AID system, but I don’t exist yet—I’m just an idea. I live in the minds of some scientists and researchers who think that I have the potential to one day become a reality. But, turning an idea into reality can be hard. It’ll take a lot of people, time, and effort for me to exist—but it’s not impossible. The question is: how? Answer: it starts with funding.
2005: Breakthrough T1D launches the Artificial Pancreas Project
Breakthrough T1D dedicates funds to scientists and researchers who have compelling ideas to turn AID systems into a reality, marking the start of the decades-long Artificial Pancreas Project (APP). These investments were key in jump-starting research into all the components needed to make an AID system work.
“[The goal was] to keep people alive and healthy until we find a cure. We were losing people…overnight of low blood sugars. If we could automatically dose insulin and have everybody go to sleep and all wake up, that was an incredible victory.” -John Brady, member of Breakthrough T1D Executive Committee in the early 2000s, former Chair of Breakthrough T1D’s International Board of Directors, and father of a son with T1D
It’s 2008. Scientists are making progress on the three key parts that need to work in harmony for me to become a reality: a continuous glucose monitor (CGM), an insulin pump, and an algorithm that lets them talk to each other. But, like most new ideas, before I’m allowed to be tested on humans, I need to be tested in animal models first. Lucky for me, I skipped this step because someone made a tool that could simulate how I would act if I was attached to a human being.
2008: Breakthrough T1D-funded scientists create simulator tool to bypass animal studies
The simulator tool, developed from the initial Breakthrough T1D grants, allowed scientists to model how an AID system would respond to real-life scenarios, like eating a certain amount of carbs or exercising, and how this would translate to blood sugar outcomes like time in range or hypoglycemic events. The FDA accepting the use of this tool was a major win—without animal studies, AID system development was accelerated by years.
“The simulator saved at least five years of animal studies because we didn’t require an algorithm to be tested in an animal model to be deemed safe and effective before going into human studies. That entire chunk was eliminated.” -Sanjoy Dutta, Ph.D., Breakthrough T1D Chief Scientific Officer
It’s 2012. Scientists have come up with different versions of my components that are ready to be tested in humans. For the next four years, I’ll be attached to people with T1D around the world who courageously volunteered themselves to test if I actually work. Turns out, I do a pretty good job at managing blood sugar—and I’m safe!
2012 to 2016: AID systems make headway in clinical trials
While clinical trials for AID systems started in earnest in 2008, they kicked into high gear in 2012, when investigators started conducting trials using different AID components and algorithms in real-life settings. Progress moved quickly, and results from numerous studies supported the idea that AID systems are both safe and effective. Breakthrough T1D funding—along with the Special Diabetes Program—helped move these trials forward.
“Getting involved in AID system trials to me was my chance to pay it forward for somebody else. I have lived 45 years with T1D…I think there’s something comforting in knowing that my body was used for something that not only had the potential to make me healthier, but really was for other people. I do think there’s something to be said for doing good, feeling good, and this is what it felt like being part of trials.” – Alecia Wesner
Flashback to 2009. While scientists are busy figuring me out, people at Breakthrough T1D are already thinking about and planning for my future—and how to work with the decision-makers at the FDA who will ultimately decide my fate. The FDA has also given their two cents about the best ways researchers can test me in clinical trials to get the data needed for me to get approved. Fast forward to 2016, it finally happens: I get FDA approval!
2009 to 2016: From APP roadmap to FDA approval
In 2009, Breakthrough T1D published the AP Roadmap, detailing what the future of AID systems will look like—and how we plan to get there. Two years later, we worked with the FDA on clinical trial design for AID systems so that there was a clear path to approval. After human clinical trials, the FDA approved Medtronic’s hybrid closed-loop MiniMed 670G—officially marking the first AID system to be available in the U.S.
“I do give [Breakthrough T1D] credit for pushing, for saying there’s a real need for this.” -Jeff Shuren, M.D., Head of the Center for Devices and Radiological Health at the FDA at the time
Flashback to 2008. At this time, people were still unsure if one of my main components—a CGM—was a reliable way to measure blood sugar. This all changed when a first-of-its-kind clinical trial showed that CGMs are better than finger pricks and glucose meters, and they were covered by insurance shortly after. This decision paved the way for my future: after my approval in 2016, insurers began offering to cover me.
2008 to 2017: Insurance coverage evolves
The landmark Breakthrough T1D-funded clinical trial in 2008 provided the data to convince private insurers to cover CGMs. Nearly a decade later, Breakthrough T1D launched its “Coverage2Control” campaign to advocate for insurance coverage of T1D treatments, therapies, and devices—including AID systems—ultimately resulting in all major private insurers offering coverage of AID systems by the end of 2017, followed by Medicare shortly after.
“Seeing the artificial pancreas go from concept to reality…is what makes Breakthrough T1D and all of the advocacy volunteers—who sent an email, made a call, signed an action alert, or met with their Member of Congress—very proud of this historic achievement and the impact that these will have on the individual lives of those with type 1 diabetes.” -Cynthia Rice, former Chief Mission Strategy Officer at Breakthrough T1D
It’s present day. There are tons of iterations of me, and even more coming. People get to choose which version of me they like best. I’m covered by most health insurance. I’ve come a long way since I was just another thought in the minds of a few scientists who had a vision… and now I’ve come to life! Even so, not everyone has chosen to use me yet—and I will continue to evolve and grow until I can make the lives easier of as many people with T1D as possible.
2017 and on: More and more AID systems come to life
After the first hybrid closed-loop AID system was approved, the flood gates were opened. More and more systems are coming to market each year, and they keep getting better. They’re smaller, easier to use, and better at managing blood sugar. They’re covered by both government and private insurance plans. They’re an integral part of routine discussions between people with T1D and their healthcare providers, and people have options to choose which system is best for them. This is a future that was difficult to imagine two decades ago—and now it’s a reality. Even so, the work continues until AID systems are a reality for more and more people with T1D.
“What we brought to bear is resulting in a safer and easier life for hundreds of thousands, and soon millions, of people with T1D, including my son, that is going to keep them safe until something like a cure comes along,” -Jeffrey Brewer, one of the APP founders
It took tons of time, money, people, and effort to get us where we are today, but we’re not at the finish line yet. “The end game for AID systems,” says Breakthrough T1D CEO Aaron Kowalski, Ph.D., “is to have multiple compatible pumps, glucose sensors, and algorithms, so that patients can mix and match what they prefer.”
The end game for T1D as a whole, however, is cures. AID systems have greatly improved the lives of those with T1D—and will continue to do so now and in the future—while we continuously work toward cures that are one day available to everyone with the condition.
The path followed for AID systems is a roadmap for other therapies coming down the pipeline. Breakthrough T1D’s Project ACT is taking a page from the AP roadmap and applying it to cell therapies, so that functional cures can get to people with T1D who want them as quickly and safely as possible.
While I’m proud of my work as a scientist at Breakthrough T1D on AID systems (and my brother and I currently wear AID systems that are derived from Breakthrough T1D-supported work), more than anything else I want to take off my diabetes devices and achieve what our founders set out to do—find cures for T1D.”
Breakthrough T1D successfully took an idea and turned it into a reality—and we’ll do it again and again until T1D is a thing of the past.
This past week, the FDA and Sanofi, the maker of Tzield, made an important announcement. Tzield, the first disease-modifying therapy approved for delaying onset of stage 3 type 1 diabetes (T1D) in people with stage 2 T1D, has been accepted into the FDA Commissioner’s National Priority Voucher (CNPV) program for people with stage 3 T1D.
Here’s what it means—and why.
The CNPV program aims to accelerate the drug review process for companies aligned with U.S. national priorities that address a large, unmet medical need while maintaining the FDA’s rigorous standards for safety, efficacy, and quality.
This program endeavors to reduce the review time for products from 10-12 months to 1-2 months. However, the program does not guarantee approval and the FDA reserves the right to determine the best course of action for the product’s being reviewed.
On Friday, October 17, the first 9 recipients of vouchers were announced, and Sanofi received one for Tzield in stage 3 individuals.
In short: the FDA recognizes there is a large unmet need in the T1D population, and Tzield has the potential to address these needs.
Sanofi’s Tzield is the first disease-modifying therapy approved to delay onset of stage 3 T1D in people with stage 2 T1D. (Stage 2 T1D is indicated by the presence of multiple autoantibodies and abnormal blood sugar levels, but individuals are not requiring insulin therapy yet). Tzield, which has been supported by Breakthrough T1D for decades, has been a gamechanger in T1D as it’s the first therapy for this disease that addresses the root cause of T1D, not the symptoms. It targets the T cells that are responsible for destroying insulin-producing beta cells, slowing down the autoimmune processes that cause T1D. In stage 2, this means a stage 3 diagnosis is delayed an average of 3 years.
The problem: it’s only approved for use in stage 2 T1D. The vast majority of people in stage 2 don’t even know they have early T1D because there are no external symptoms. The only way of knowing is to get screened for risk markers of T1D. While the number of individuals screened for T1D has dramatically risen in recent years, most people who may benefit from the drug progress to stage 3 before they have the chance to reap its benefits—and delay onset.
Additionally, Tzield already being reviewed under the FDA’s accelerated approval program. Sanofi is continuing to study Tzield in this patient population through the confirmatory BETA-PRESERVE phase 3 study, which will provide more information on the risks and benefits of the drug in the coming years.
Breakthrough T1D has supported the development of Tzield for decades—and supports its use in stage 3 T1D.
T1D is caused by the destruction of the beta cells, which are the only cells in the body that make insulin. The fewer beta cells a person has, the less insulin they make.
Simply put, it’s better to have more beta cells, and longer we can keep those cells alive and making insulin, the better. There are many studies that support this, but one study in particular really demonstrated the benefits.
In the PROTECT study, Tzield was administered to newly diagnosed children and adolescents in stage 3 T1D to see if it could slow the destruction of beta cells as measured by C-peptide. (C-peptide is a natural byproduct of insulin production and a key biomarker as we evaluate the efficacy of Cures therapies).
In this study, investigators looked at newly diagnosed individuals who were administered Tzield compared with placebo and measured their beta cell function (using C-peptide) over time. The results were clear: Tzield significantly slowed the decline of beta cell function. This has real impact on the lives of people with T1D, too. People who received Tzield and therefore had higher levels of endogenous insulin production required less insulin and spent more time in range.
In summary: more beta cells are better. Tzield has demonstrated that it can help achieve that.
Sanofi could hear from the FDA in the next 1-2 months that Tzield has been approved for use in stage 3 T1D. If that happens, it will mean that, for the first time, individuals diagnosed with T1D have a therapy option besides insulin. This would be a historic first, allowing people to benefit from the decline in the loss of beta cells and modify the course of T1D like the PROTECT study has demonstrated.
“We know two things: there is a large, unmet need in the T1D community for more therapy options, and there is significant data demonstrating the benefits of preserving beta cell health,” said Campbell Hutton, Senior Vice President, Global Advocacy. “Breakthrough T1D applauds the FDA for accelerating the review process of a therapy that can have significant positive impact for the T1D community.”
Nearly 3 years ago, Breakthrough T1D joined forces with Civica Rx, a non-profit pharmaceutical company, to manufacture and distribute low-cost insulins. Starting on January 1, 2026, the first of those insulins, insulin glargine-yfgn (a long-acting insulin interchangeable with Lantus®), will be available for purchase.
While we have seen improvements in the affordability and accessibility of insulin in recent years, Americans who need insulin are still often required to jump through hoops to get the assistance they need to afford their insulin. Civica’s insulin is very simple: it’s no more than $55 for 5 pens, and anyone with a prescription can purchase it at a pharmacy. There are no forms to fill out, co-pay assistance programs to sign up for. It’s that simple.
This insulin is manufactured by BioCon and will be sold as Civica insulin glargine. In California, it will carry the “CalRx” brand.
Civica has shared with us that they expect broad retail availability. In the coming weeks, we look forward to sharing information on where this insulin can be purchased.
Breakthrough T1D and its amazing advocates have long championed the cause of affordable insulin, tirelessly advocating across multiple fronts—including Congress, employers, health insurance companies, and pharmaceutical manufacturers.
Civica’s announcement marks another significant milestone in the journey toward insulin affordability. This development joins other encouraging progress made in recent years, such as the implementation of a $35 monthly insulin cap for Medicare recipients and the decision by the three major insulin manufacturers to lower their prices.
Despite these advances, Breakthrough T1D continues to advocate for and advance comprehensive legislation that guarantees insulin will remain accessible and affordable for all, regardless of insurance status or income level. Access to insulin is not just a policy issue—it’s a mission priority. We must continue to work to ensure that people with T1D remain healthy and well-supported as the search for cures continues.
“For people with type 1 diabetes, insulin is a lifesaving drug. Too often, the cost of insulin is a barrier that causes people to make difficult decisions between their medication and other necessities,” said Aaron J. Kowalski, Ph.D., Breakthrough T1D CEO. “The availability of Civica’s insulin glargine is a significant next step in ensuring that insulin is accessible and affordable for people with type 1 diabetes and all those who need it, regardless of their insurance status. Breakthrough T1D is proud to partner with Civica as they continue their efforts to develop affordable insulins for the diabetes community.”
Civica has not strayed from its initial goal: to sell biosimilar insulin options for the three most-prescribed insulins: glargine (Lantus®), lispro (Humalog®), and aspart (Novolog®). Aspart will be the next insulin sold by Civica and we look forward to future updates about its progress.
Breakthrough T1D strives to accelerate life-changing breakthroughs to cure, prevent, and better treat type 1 diabetes (T1D) and its complications. To accomplish these goals, we use a multi-pronged strategic approach, including conducting scientific studies and educating our community. In line with these goals, Breakthrough T1D recently published two peer-reviewed journal articles. One detailed burdensome unmet needs in the T1D community and identified key steps we can take to meet these needs. The other used real-world data to better understand American T1D demographics and predict changes in the next decade.
Let’s take a deeper dive into each.
This commentary reviews previously existing data across the T1D care spectrum to help demonstrate the magnitude and significance of the unmet needs faced by people living with T1D. This information is used to emphasize the urgency researchers, sponsors, and regulators must place on developing cures for T1D. The authors provide recommendations and actionable steps to overcome scientific, clinical, and regulatory challenges that will help meet these needs.
To say that the daily routine of people living with T1D is hard would be an understatement.
Insulin injections and dosage calculations. Wearable tech maintenance. Carbohydrate counting. Mealtime and exercise tracking. Doctor’s appointments. Hypoglycemia, hyperglycemia, and diabetic ketoacidosis (DKA) avoidance. It requires constant attention: 24 hours a day, 7 days a week.
The truth of the matter is that T1D management is a burdensome, demanding, and highly intensive task. There are no breaks, vacations, or time off—even overnight, it requires management. These challenges remain, even with today’s advancements in technology and the emergence of novel therapies for T1D. Simply put, we need to do more for the T1D community, and we cannot settle for the status quo.
The challenge of day-to-day T1D management compounds into long-term negative outcomes for the T1D population. Despite improvements in mortality rate, the life expectancy of people with T1D is still shorter than those without T1D.
Keeping blood glucose in a normal range is extremely difficult, and people with T1D need to be acutely aware of their insulin doses to prevent highs (hyperglycemia) and lows (hypoglycemia). Prolonged hyperglycemia leads to heart, kidney, and eye damage. Hypoglycemia can be very dangerous and a source of distress and anxiety, especially if it occurs often and eventually without symptoms (termed “hypoglycemia unawareness”).
Current technologies cannot solve the problem of hypoglycemia or make people with T1D have perfect blood sugar levels. As a whole, these challenges represent a profound emotional and mental burden for people with T1D, often leading to diabetes distress and burnout—which itself can lead to worse glycemic control. People with T1D have a tougher time managing the ins and outs of daily life because of the extreme mental and physical load of having T1D.
A longer life on its own is not the goal: it’s longer lives without ever having to think about T1D.
Breakthrough T1D envisions a world where the burden of T1D no longer exists. A world where people don’t have to manage their diabetes—they don’t take insulin, don’t have blood sugar highs and lows, and don’t develop complications. Curing T1D is our north star.
To achieve these goals, we need widespread screening, innovative research and therapies, patient-centered clinical approaches, and evolved regulatory pathways. We need to adjust the T1D paradigm and move clinical testing along at a quicker pace.
The regulatory route for new therapies determines whether companies, which have the greatest ability perform research in a quick and efficient manner, will invest their time and money into innovative T1D therapies. They are more encouraged to do so if they see defined and reasonable pathways for new therapies to reach the market—especially if healthcare systems are in place that will allow these therapies to be adopted by healthcare professionals and used by the people who need them most.
It starts with the decision-makers, who weigh the benefits versus risks of a new therapy. These decisions need to have more input from people who have a lived experience with T1D and can better decide if the benefits outweigh the risks, especially given the tremendous daily burden of living it. Clinical testing should broaden to include more populations of people with T1D—not just those who have severe disease—because nearly everyone has the chance to benefit. As the authors state in the commentary:
The magnitude of benefits required to outweigh a product’s risks should be determined by people living with T1D and no one else.
To further optimize T1D clinical trials, Breakthrough T1D and other experts have pushed for the validation of C-peptide, a biomarker for the body’s insulin production, as a clinical trial endpoint. Compared to the currently used endpoints, C-peptide would provide easier assessments and shorter clinical timeframes, thereby making the process of T1D therapy development more streamlined—and bringing these data to decision-makers sooner.
Once better clinical endpoints are validated, more personal experiences are incorporated into clinical trials, and the regulatory path to market is clear, companies will be encouraged to invest in T1D research programs, thereby speeding up research, innovation, and progress along the clinical pipeline—getting life-changing therapies into the hands people with T1D faster than ever.
This publication will be shared broadly with regulators, legislators, payers, and the T1D research community to encourage research, innovation, and funding and advocate for quicker, more efficient clinical testing and regulatory pathways to approval.
I think the misperception that the therapies available today are good enough is one of the most insidious challenges to ushering in the era of T1D cures…Today’s therapies do not offer the freedom from diabetes that people living with the disease want…I believe when we fully appreciate the daily experiences of people living with T1D, and when we use these experiences to guide our research development and regulatory decisions, we will also then have clear pathways for new therapies that meet these needs.”
This is a call to action for everyone working in the T1D space. The overarching purpose is to foster awareness of these unmet needs and the urgency with which we must act as a community to address them—by working together and collaborating across the pipeline of T1D management.
Read on to learn more about the population of people living with T1D with these unmet needs.
The purpose of this study was to identify key T1D demographics in the United States and predict how these demographics will change over the next decade. Using healthcare insurance claim datasets, population growth projections, and existing literature, the authors modeled T1D demographic changes between 2024 and 2033.
This study was funded by Breakthrough T1D in collaboration with the T1D Index team so that these data can be incorporated into the Index. (Disclaimer: the T1D index uses multiple datasets and publications to predict the number of people living with T1D, which may explain discrepancies in Index estimates and predictions from this study).
Incidence
The number of new T1D diagnoses in a given time period.
Prevalence
The total number of people with T1D (new and existing diagnoses) in a given time period.
Number of people in the U.S. living with T1D.
Average age of people living with T1D.
Percent of people with T1D who are 20–64 years old.
Percent of people with T1D who are over 65 years old.
Percent of people with T1D who have commercial health insurance plans. Other coverage includes Medicare (30%) and Medicaid (15%).
Number of people in the U.S. living with T1D (due to increase in T1D incidence and improved survival from devices).
Average age of people living with T1D.
Percent increase in T1D population that aged 65 and older (mostly due to aging of the current T1D population).
Percent increase in T1D population that is aged 10 and younger.
Percent of people with T1D who have private/commercial health insurance plans. Other coverage includes Medicare (30%) and Medicaid (17.4%).
Percent increase in T1D population who will use Medicaid.
Despite significant advances in T1D technology, therapies, and care management, the T1D population still faces a greater risk of complications and a higher mortality rate. Breakthrough T1D leadership will use key information from this study to inform future strategic research and advocacy efforts.
This data gives us an opportunity to quantify key information about our community to inform decision-makers…With better data specific to those with T1D, we can ensure that we’re advocating for solutions that not only expand access but also promote a better health care system for those with T1D.”
These data will help inform elected officials and payers about how healthcare policies may ultimately affect the T1D community—ensuring that the policies in place are having the greatest impact they can. The next phase of the project will analyze key demographic information in the context of access to cell therapies.
The ultimate goal is to ensure that everyone with T1D has access to the therapies, technology, and care that works best for them. By understanding T1D population demographics, Breakthrough T1D can make the most informed decisions possible as we move toward our goal of a world without T1D. We call on regulators, legislators, payers, and T1D researchers to take urgent action to meet the unmet needs of the T1D community now and in the future.
Project ACT series
This article is part of a series exploring the different ways that Breakthrough T1D’s Project ACT (Accelerate Cell Therapies) will shape the future of cell therapies for type 1 diabetes (T1D). The next article in the series will discuss the progress of cell therapies in clinical trials.
We’ve made major progress in the development of cell replacement therapies for type 1 diabetes (T1D) over the past couple of decades. We know that manufactured islets, such as Vertex’s VX-880 (now Zimislecel), can restore insulin therapy independence and glucose control when implanted into people with T1D.
However, there is more work to do.
We need to make sure the cells survive and function, ideally without immunosuppression, and ensure that these therapies are accessible to everyone with T1D. Read on to learn more about where there’s room for improvement and what we’re doing about it.
Current external cell sources that are not manufactured in the lab, such as those from deceased donor pancreases or a person’s own cells, are in extremely limited supply. The only FDA-approved cell therapy for T1D, Lantidra®, requires donor cells, and it can take up to three pancreases to get enough islets for one transplant. This is unsustainable and limits the number of people who can get this therapy.
We can consistently generate an unlimited source of islet cells in the lab. This way, we can make enough insulin-producing cells for everyone with T1D and have a single cell source to test and compare multiple strategies to protect them.
Breakthrough T1D is funding an initiative at the Advanced Regenerative Manufacturing Institute (ARMI) to scale up Dr. Jeffrey Millman’s protocol to generate unlimited manufactured islets in a reliable, automated, and reproducible way. Breakthrough T1D is also building a partnership with the Cedars-Sinai Biomanufacturing Center to accomplish this goal.
Implanted islets that move through the bloodstream can cause an inflammatory reaction, resulting in cell death. Alternatively, those that are implanted in devices that are cut off from the blood and immune system are unable to get nutrients and oxygen, again leading to cell death.
It doesn’t have to be the pancreas, but islets need access to nutrients and oxygen so that they can survive for long periods of time and produce insulin.
Breakthrough T1D is funding research to develop scaffolds, which are specialized biomaterials that islet cells can stick to and get nutrients and oxygen to help them survive. Similarly, islets implanted in encapsulation devices, such as Sernova’s Cell Pouch™, can access nutrients and oxygen while having the added benefit of being protected from the immune system. There are also various Breakthrough T1D-funded clinical studies that are investigating different places in the body for manufactured islets, including the omentum and abdominal wall.
Omentum
The omentum is a fatty tissue layer that surrounds and protects the organs in your abdomen. Researchers are testing it as a new implantation site for manufactured islets.
Like organ transplants, manufactured islet therapies from an external source are recognized by the immune system as “non-self,” leading to immune rejection. Currently available cell therapies require broad immunosuppressants that may come with unwelcome side effects, including increased risk of infection and malignancy and toxicity to kidneys, nerves, and islet cells themselves.
By swapping standard immunosuppressives with options that have less complications, more people with T1D will be able to access these therapies.
Research and clinical studies funded by Breakthrough T1D approach immune protection from many different angles. This includes genetically engineered islets that can evade immune detection, encapsulation devices, and immunomodulatory therapeutics that can dampen the immune response.
There’s a lot of promising solutions in the pipeline. What’s next? Unlocking access.
“We recognize that approval of cures is not a life-changing breakthrough if people do not have access to the therapy itself,” said Aaron Turner-Phifer, Senior Director of Health Policy at Breakthrough T1D. “Building on the experience gained from past breakthroughs, we are working now, across our Mission teams, to identify and remove any potential barriers to people accessing cell therapies.”
“While our work is just beginning, we’ve already conducted market analysis to identify clinical and payer barriers to give us clarity on where to start. We are directly engaging policymakers and health plans to educate them on T1D cell therapies. We’ve also launched data projects to begin to generate the types of data required to positively inform future policy and coverage decisions.”
Aaron Turner-Phifer
In the coming years, it’s likely that first-generation manufactured islet therapies will be available to people with T1D with severe hypoglycemia unawareness and will require broad immunosuppression.
Later, advancements in cell survival and immune protection—combined with the advent of more tolerable immune suppression approaches—will open the doors for more people with T1D to access these life-changing therapies.
Scientific progress takes time, money, and effort. To accelerate islet replacement therapies faster than ever, Breakthrough T1D launched Project ACT (Accelerate Cell Therapies) to simultaneously advance research, development, regulatory policies, access, and adoption of manufactured islet therapies that do not require broad immunosuppression.
Without continuous support from the T1D community and its supporters, we would never have gotten this far. Breakthrough T1D looks forward to a future where manufactured islet therapies are a reality for everyone with T1D, and we will not stop until we get there.
From March 1 to 4, 2025, Breakthrough T1D’s annual Government Day once again brought 185 dedicated volunteer advocates from across the country to Capitol Hill in Washington, D.C., to advance our priorities. After two days of coalition building, volunteer recognition, and briefings from our Advocacy and Research teams, our extraordinary advocates met with nearly every Congressional office. Together they emphasized the importance of supporting type 1 diabetes (T1D) research progress by renewing the Special Diabetes Program (SDP), protecting critical T1D research and staffing, and accelerating cell therapies.
The first item on the agenda: renew the Special Diabetes Program (SDP).
The SDP is a Federal program that currently allocates $160 million each year to T1D research through the National Institutes of Health (NIH). Since its inception in 1997, the SDP has funded $3.5 billion in T1D research! The program supports research at all stages of T1D, including cures, prevention, and treatments. It has yielded significant advancements for the T1D community, including:
Just days after Government Day wrapped, Congress and the President enacted a six-month, $80 million renewal that funds the program through the end of September, 2025. This achievement is the result of strong bipartisan support fueled by the voices represented at Government Day, our countless advocates around the country, and the steadfast leadership of Congressional champions like Senate Diabetes Caucus co-chairs Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), and Congressional Diabetes Caucus co-chairs Representatives Diana DeGette (D-CO) and Gus Bilirakis (R-FL).
“The Special Diabetes Program has fundamentally changed life for the 1.6 million Americans who, like me and my daughter, live with type 1 diabetes. Breakthroughs like artificial pancreas technology and beta cell replacement therapies are possible because of the Special Diabetes Program,” said Breakthrough T1D Chief Global Advocacy Officer Lynn Starr.
Our advocates delivered another key and timely message: Congress must maintain the momentum toward finding cures and ensure strong funding and staffing for essential agencies like the NIH and FDA.
Breakthrough T1D believes in having efficient government agencies and programs that serve the best interests of the American people. Taxpayer dollars should always be spent thoughtfully and purposefully, focusing on advancing the public good. But we can’t slow down the incredible momentum towards T1D cures. Our advocates urged Members of Congress to do all they can to retain key staff at leading T1D related health agencies, prevent drastic cuts to NIH research grants, and provide strong appropriations to agencies so they can deliver cures, prevention strategies, and new treatments.
Our north star is curing T1D. If we can manufacture insulin-producing cells and safely put them inside the body to replace the cells that were lost, we’ll have cured the disease. Today, cells like these are in human clinical trials—and they’re producing insulin. Clinical trial results are very promising, and one cell therapy product is entering the final trial stage before approval. The next step is keeping cells safe in the body without using drugs that have serious side effects. Researchers are working on this in several ways, from placing them inside a protective barrier to modifying cells so they are undetected by the immune system. Project ACT (Accelerate Cell Therapies) is Breakthrough T1D’s initiative to speed up the development of cell therapies and allow us to walk away from T1D for good. In their meetings, our advocates gave a preview of Project ACT and asked that Members of Congress support policies to speed the way to cures.
Congresswoman Kim Schrier, MD (D-WA), the only current Member of Congress with T1D and first pediatrician elected to Congress, spoke to our advocates about her personal experiences and the impact of the Special Diabetes Program on those living with T1D.
“As a doctor and a person with type 1 diabetes, I understand the challenges that come with managing this disease. That’s why I’ve worked hard in Congress to help others, including advancing legislation to improve diabetes self-management training, enhancing awareness and screening for T1D, and lowering insulin costs for millions of Americans,” said Congresswoman Schrier, M.D. “Through this advocacy, I’ve had the pleasure of working with the incredible Breakthrough T1D team. I am grateful for their dedication to research, treatment, prevention, and someday cures for this disease.”
Click here to view her full remarks.
In just a few months, 165 youth living with type 1 diabetes will gather for Breakthrough T1D 2025 Children’s Congress—our biennial event that brings Delegates from across the country and around the world to Washington, D.C., to share their experiences with the disease, and to advocate for issues that are important to the T1D community. Until then, please join us and use your voice to help people with T1D!
While we look back on 2024, we can reflect upon the incredible progress we’ve made in advancing breakthroughs toward cures and improving everyday life with T1D.
This wouldn’t have been possible without each and every one of you and your continued support of our mission as we drive toward cures for T1D.
Breakthrough T1D announced the launch of Project ACT, an initiative aimed at accelerating breakthroughs in T1D cell replacement therapies that do not require broad immunosuppression. Recent advances, such as Vertex’s stem cell-derived islets, have been made possible by Breakthrough T1D’s Cell Therapies program as part of our drive toward cures. The goal of Project ACT is to push research, development, regulatory policies, access, and adoption to increase the rate at which cell therapies without the need for broad immunosuppressants will become available to people with T1D.
Why this matters: Immunosuppressive drugs are a barrier to access to cell replacement therapies because of their toxic side effects, which is why islet transplants are currently only available to people with severe low blood sugar (hypoglycemic) unawareness and episodes. By striving toward a future where we realize the benefits of cell replacement therapies without the downsides of the current regimen of immunosuppressants, we will make islet replacement therapies broadly accessible to the T1D community.
Vertex’s clinical trial of VX-880, a first-generation stem cell-derived islet replacement therapy for people with severe hypoglycemia (requiring the use of immunosuppressants), has transitioned into a phase 1/2/3, or pivotal, trial. This news comes after Vertex shared incredibly promising data in the earlier phases of the trial, including 11 of 12 participants reducing or eliminating the need for external insulin.
The upcoming trial will expand to 50 people who will get a single, target dose of VX-880. The primary endpoint will be insulin therapy independence without severe hypoglycemic events after one year. This is the final clinical testing stage before Vertex can seek FDA approval.
Breakthrough T1D has a decades-long relationship with Vertex and the leading scientists behind stem cell-derived islet therapies, an advancement that would not have been possible without Breakthrough T1D funding and support. The T1D Fund had invested in Semma Therapeutics, which was acquired by Vertex Pharmaceuticals in 2019, eventually leading to the active clinical development of VX-880 in T1D.
Why this matters: This is the first time a scalable cure for T1D is entering phase 3 clinical trials—a significant win and a huge step toward accelerating the delivery of cell therapies to members of the T1D community!
Tegoprubart: Transplant Survival Without Standard Immunosuppressive Drugs
Tegoprubart, an anti-CD40L immunotherapy that limits the immune response, is being tested in a Breakthrough T1D-funded study in people with T1D and severe hypoglycemia who have received deceased donor islets. Eledon Pharmaceuticals announced promising initial results in which two of three people achieved insulin therapy independence. According to the study, tegoprubart is safer for both people and transplanted cells in comparison to broad immunosuppressants, with milder side effects and greater islet survival. To further support this effort, the T1D Fund: A Breakthrough T1D Venture invested in Eledon.
Cell Pouch: A Home for Transplanted Islets
Breakthrough T1D has been supporting the development of Cell Pouch, an implantable device from Sernova that provides a safe, immune-protected environment for transplanted islet cells. In phase 1/2 clinical trials, all six people who received donor islets within the Cell Pouch achieved sustained insulin therapy independence with immunosuppressants, including long-term islet survival and function over five years without harmful side effects.
Why this matters: Standard of care immunosuppressive drugs that help avoid transplant rejection come with unwelcome side effects, such as increased risk of infection and malignancy and toxicity to kidneys, nerves, and islet cells themselves. Breakthrough T1D is focused on finding alternative ways to keep transplanted islet cells alive and healthy so that cell replacement therapies can become more tolerable and accessible.
In a major effort spearheaded by Breakthrough T1D, the first internationally recognized clinical guidelines for those who test positive for T1D autoantibodies have been published. These include guidance on monitoring frequency, education, and psychosocial support in addition to recommended actions for healthcare professionals (HCPs) when the risk of T1D progression is high. The guidelines were cooperatively developed with over 60 international experts spanning ten countries.
Why this matters: Previously, there had been no consensus on monitoring guidelines for people who test positive for T1D autoantibodies. Standardization of clinical recommendations means that individuals, families, and HCPs have tangible next steps to monitor early T1D progression and catch life-threatening complications sooner.
Why this matters: T1D early detection is critically important to prevent life-threatening complications at diagnosis and to give people necessary resources to make informed decisions about their health. Integrating T1D screening into the U.S. healthcare system will increase access to care.
The past year has seen some important advances in glucose management therapies and devices:
Why this matters: While advancements in glucose management have been pivotal in improving health outcomes for people with T1D, access remains a challenge. AID systems are globally underutilized, and not everyone has the necessary technology to connect devices. Breakthrough T1D is working to not only support advances in glucose management but also increase access.
Related content: While Breakthrough T1D consistently strives to improve the lives of those living with T1D, as an organization we have made incredible progress in the development of AID systems, also called the artificial pancreas systems. Read a historical perspective written by Breakthrough T1D volunteer Doug Lowenstein that covers conception to FDA approval of the first artificial pancreas systems, which changed the lives of people with T1D.
An inquiry spearheaded by the Breakthrough T1D affiliates in the U.K. uncovered risks of developing T1D eating disorders (T1DE), including bulimia, anorexia, or insulin restriction to lose weight. There is a significant gap in education and clinical guidelines for HCPs, a lack of internationally recognized criteria for T1DE diagnosis, and insufficient care integration, leading to preventable complications and healthy years of life lost. Breakthrough T1D recognizes the importance of spreading awareness and support for T1DE, and much work is needed to improve the lives of those living with T1DE.
Why this matters: There is an urgent need to change the way T1DE is approached, including integrated physical care with mental health services to get people with T1DE the access to care that they need.
In a study that included people with T1D, finerenone (Kerendia®) has been shown to improve cardiovascular outcomes in adults with heart failure. The drug is already approved in the U.S. to treat kidney and cardiovascular disease in people with T2D. Based on these results, Breakthrough T1D is supporting a clinical trial (FINE-ONE) in conjunction with Bayer to investigate the use of finerenone for T1D with the hopes of reducing kidney complications.
Why this matters: Kidney and cardiovascular disease remain significant challenges for those with T1D, especially given the FDA’s recent rejection of an SGLT inhibitor to lower blood glucose in people with T1D and chronic kidney disease. Yet, a new clinical trial (SUGARNSALT) will better assess the benefits versus risks.
Breakthrough T1D is advocating for the regulatory approval of C-peptide, a biomarker for insulin production by beta cells, to be used as an endpoint in clinical trials. An endpoint can accurately predict a meaningful benefit in clinical trials for disease-modifying therapies (DMTs; treatments that can slow, halt, or reverse T1D). To support this endeavor, Breakthrough T1D scientists and an expert consensus panel published research with evidence supporting C-peptide as an endpoint. Breakthrough T1D is continuing to engage with regulators, coordinate with industry, and assess more clinical trial data to drive this effort forward.
Why this matters: Current clinical trial endpoints (HbA1c, hypoglycemia, and complications) are not the best way to gauge the clinical benefits of T1D therapies. If C-peptide gets regulatory approval to be used as an endpoint, clinical trials could be smaller and shorter while still accurately assessing the advantages of a DMT. This means that drug development can move more quickly, and people with T1D will be able to access therapies sooner.
Related content: Two years ago, the T1D community received the incredible news that Tzield® had become the first FDA-approved disease-modifying therapy that can significantly delay T1D onset. Breakthrough T1D volunteer Doug Lowenstein recounts the life-changing drug’s journey nearly 100 years after the discovery of insulin.
The T1D Index is a data simulation tool that measures the global health impact of T1D, bridging gaps in our knowledge of public health statistics. T1D Index 2.0 has new and improved functionality, including advanced simulation capabilities, validation of data, and enhanced user experience. Breakthrough T1D contributed to both the development and improvement of the T1D Index.
Why this matters: The T1D index is critical in defining the intercontinental scope of T1D, driving us toward country-specific solutions and improved global health outcomes.
Earlier this year, JDRF rebranded to Breakthrough T1D. While our mission remains the same, our name needs to better reflect who we are and where we’re going. Our new brand aligns with our mission to accelerate life-changing breakthroughs for those of every age living with T1D as we work toward a world without it.
Why this matters: The proof is in the name—each day we strive to increase and accelerate breakthroughs in T1D, and it’s critical for our brand to accurately reflect our mission.
It’s certainly been an exciting year! While we still have more work to do, it’s crucial to celebrate our wins, both big and small, to see how far we’ve come in our push to make T1D a thing of the past.
Together, we’re accelerating breakthroughs for people with T1D, and the support of the T1D community drives our mission forward every single day, leading the way to lifechanging therapies and cures. Let’s see what 2025 has in store!
On October 1st, the T1D community got a big win: the Centers for Medicare and Medicaid Servies (CMS) introduced a unique ICD-10 code for stage 2 type 1 diabetes (T1D). This addresses a significant gap in clinical care. Prior to this change, clinicians had limited options for coding stage 2 T1D, which resulted in inaccurate patient records.
This may seem like a minor detail but it’s critical! It will profoundly affect physicians’ abilities to diagnose and treat people with stage 2 T1D.
ICD-10 codes are codes used by healthcare providers to classify and document diagnoses, symptoms, and procedures. These codes provide a unified way for doctors and providers to indicate what diseases or conditions a person has in their electronic health record (EHR).
The ICD-10 code for stage 3 T1D, or clinical diagnosis of T1D is E10. If that code is in a person’s EHR, a physician immediately knows that they have T1D. Having that information can help them provide proper care to their patients.
Stage 2 T1D is defined by the presence of autoimmune antibodies (AAB). Autoantibodies are proteins in the blood that indicate the body’s immune system is attacking the insulin-producing cells in the pancreas. People in stage 2 are usually asymptomatic, but they can experience dysglycemia, or abnormal blood sugar levels.
The only way individuals can find out if they are in stage 2 T1D is through antibody screening.
Stage 2 and stage 3 T1D are not the same. They are not managed in the same way or treated in the same way. For a healthcare provider to give the appropriate care, they need the correct diagnosis.
The previous lack of an ICD-10 code for this early stage of T1D meant that individuals could be misclassified, either reflecting stage 3 T1D or no T1D at all. This means they may not be getting the proper care and monitoring of the disease’s potential progression.
The introduction of a specific code for stage 2 T1D has significant implications.
Breakthrough T1D played a significant role in advocating for the creation and adoption of this code. We crafted a letter in support of this code that several of our peer organizations signed onto. We also galvanized the clinical side to add their support to this initiative, all of which were instrumental in the code creation and adoption.
The recent introduction of ICD-10 codes for Stage 2 T1D is a significant step forward for the T1D community. By accurately identifying individuals at this critical stage of T1D, healthcare providers can treat and monitor them accordingly, improving both patient outcomes and enhancing our understanding and management of T1D.
