Breakthrough T1D was on site in Chicago, IL from June 20-23 for the American Diabetes Association’s (ADA) 85th Scientific Sessions. We’ve reported on the latest-and-greatest type 1 diabetes (T1D) advancements—including many driven by Breakthrough T1D funding. See below for all our ADA 2025 coverage spanning cures, improving the lives of people with T1D, and clinical adoption of T1D therapies, treatments, and devices.


ADA recap with Aaron Kowalski, Ph.D.

Looking for more ADA news? Tune in below to hear Breakthrough T1D Chief Executive Officer Dr. Aaron Kowalski cover the top advancements presented at ADA 2025.

Thanks for joining us throughout our coverage of the ADA 85th Scientific Sessions. We’ve made incredible progress across all our research priorities areas, including cures therapies, treatments, and devices. Breakthrough T1D staff and leadership were on-site hosting and participating in panel discussions, meeting with industry leaders, and engaging with researchers from around the world to accelerate T1D research progress. Breakthrough T1D-funded research was front-and-center, showcasing the reach of our impact driven by supporters like you. That’s a wrap on ADA 2025—we’re already looking forward to ADA 2026!

ADA Recap Series

This article is the last of our three-part ADA Recap Series. Breakthrough T1D was on site in Chicago, IL from June 20-23 for the American Diabetes Association’s (ADA) 85th Scientific Sessions. We’re here to report on the latest-and-greatest type 1 diabetes (T1D) advancements—including many driven by Breakthrough T1D funding.


Guidelines for T1D management

Guidelines for cardiovascular and kidney disease in T1D

Continuous ketone monitoring (CKM): Why does it matter?

CKM technology can have transformative benefits for intervening early when ketones are rising to prevent diabetic ketoacidosis (DKA), among other uses. Breakthrough T1D has been supporting the development of CKM technology, but it’s not quite a reality yet. However, we’re working hard to bring CKM to the T1D community, and we believe we’ll be there soon.

Scenes from the Symposium “Continuous Ketone Monitoring – Innovations and Clinical Applications”

Education and awareness

Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, Vice President of Medical Affairs (second from right) participates in a panel about women in diabetes professions.

Precision medicine

Precision medicine refers to therapies and treatments that are targeted to a specific population of people based on genetics or other factors. This subpopulation is likely to respond more favorably to the precision medicine intervention compared to the general population.

Esther Latres, Ph.D., Vice President of Research (right) hosts a panel discussion on cell therapies for T1D.
Marjana Marinac, Pharm.D. (second from left) speaks on panel about health policy in diabetes.

From T2D to T1D: Shortening the clinical trial timeline for repurposed drugs

Biomarker

A biomarker is a measurable change that is indicative of disease or response to a therapeutic intervention.

Bridging biomarker

A bridging biomarker can be used to extrapolate the effectiveness of a treatment from one indication or population to another. In this case, a bridging biomarker that was effective in measuring therapeutic benefit in type 2 diabetes (T2D) can be used to measure the same benefit in T1D.

Finerenone for T1D

The ADA 85th Scientific Sessions have officially come to a close—and we were inspired and energized by the incredible advancements we saw first-hand across cures therapies, treatments, devices, and Medical Affairs initiatives. Thanks to all the researchers, scientists, clinicians—including many who were funded by Breakthrough T1D—who joined the discussion and shared the exciting T1D research progress from labs and clinics around the world. See you next year!

ADA Recap Series

This article is the second of our three-part ADA Recap Series. Breakthrough T1D was on site in Chicago, IL from June 20-23 for the American Diabetes Association’s (ADA) 85th Scientific Sessions. We’re here to report on the latest-and-greatest type 1 diabetes (T1D) advancements—including many driven by Breakthrough T1D funding. Look out for tomorrow’s article for updates on Medical Affairs.


Cell therapies were front-and-center at ADA 2025. We have some exciting clinical trial updates and new ideas for optimizing islet transplantation.

Cell therapies

Autologous cell transplantation

Autologous cells are those removed from an individual and implanted back into the same individual. These cells can be modified in a laboratory before implantation. Autologous cells are still susceptible to autoimmunity in T1D, so cell protection strategies (gene-editing, encapsulation, immune modulation, etc.) are expected to be required.

Allogenic cell transplantation

Allogenic cells are those that are derived from a source other than the recipient, such as deceased donors or precursor-derived manufactured cells. Allogenic cell transplants require immunosuppression because they stimulate an immune response. Breakthrough T1D’s Cell Therapies program is focused on allogenic cells—specifically manufactured cells—because they can be generated at large scale.

One-year updates on Vertex’s manufactured cell therapy, zimislecel

6-month update on Sana Biotechnology’s immune-evasive islets

A new transplantation site for autologous manufactured islets

A new encapsulation device for immune protection of transplanted islets

Tom Bollenbach, Ph.D. presents on Breakthrough T1D-funded research at the Advanced Regenerative Manufacturing Institute.

Disease-modifying therapies

A major focus at ADA 2025 was addressing the underlying immune mechanisms of T1D—including alterations in immune cells that facilitate beta cell destruction and other factors that contribute to autoimmunity onset. Read on for some highlights.

The role of B cells in T1D autoimmunity

Early detection

A key focus at ADA 2025 was the growing recognition of the heterogeneity of T1D, including autoantibody-negative disease onset, genetic variation, and the frequent misdiagnosis of T1D in adults, underscoring the need for greater diversity and inclusion in research and care. The expanded role of continuous glucose monitoring (CGM) and continuous ketone monitoring (CKM) was also highlighted, not only for daily management but as essential tools for understanding disease progression.

Using genetics to predict T1D risk

Understanding how genetic diversity contributes to T1D

Controversies in CGM and benefits for early detection

Contributions of CKM to early detection

Jay Tinklepaugh, Ph.D., Senior Scientist, and Esther Latres, Ph.D., Vice President of Research, at Breakthrough T1D’s Islet Cells in T1D Workshop.

Look out for tomorrow’s article for an update on Medical Affairs presented at ADA 2025!

ADA Recap Series

This article is the first of our three-part ADA Recap Series. Breakthrough T1D was on site in Chicago, IL from June 20-23 for the American Diabetes Association’s (ADA) 85th Scientific Sessions. We’re here to report on the latest-and-greatest type 1 diabetes (T1D) advancements—including many driven by Breakthrough T1D funding. Look out for tomorrow’s article for updates on Cures.


Adjunctive therapies and complications

There was significant focus on GLP-1 receptor agonists (GLP-1RAs) and SGLT inhibitors (SGLTi) in reducing long-term complications and improving glycemic control in people with T1D.

GLP-1 receptor agonists

Glucagon-like peptide 1 receptor agonists mimic the hormone GLP-1, which elevates insulin and regulates appetite. Examples include Ozempic® (semaglutide) and Mounjaro® (tirzepatide), which acts on both GLP-1 and a similar target, GIP.

SGLT inhibitors

Sodium-glucose cotransporter inhibitors target kidney cells to prevent them from reabsorbing glucose into the blood so it gets excreted as waste. Examples include Farxiga® and Zynquista®.

While SGLTi and GLP1-1RAs have proven effective for heart and kidney disease in type 2 diabetes (T2D) and in people without diabetes, people with T1D have often been excluded from critical trials. Thanks to years of advocacy and support from Breakthrough T1D, T1D trials are ongoing—and real-world evidence suggests that GLP-1RAs and SGLTi could be impactful in the T1D community as well.

Real-world evidence for GLP-1RA use in T1D

A review of SGLTi and GLP-1RAs in reducing chronic kidney disease (CKD) in T1D

Glucokinase

Glucokinase (GK) is an enzyme in liver cells that works in an insulin-dependent manner to regulate blood sugar. In people with T1D who have little insulin reaching the liver, GK can’t work as normal, contributing to higher blood sugar.

Use of a glucokinase activator for glycemic control

Devices

Real-world insights from Automated Insulin Delivery (AID) systems

Real-world evidence: iLet Bionic Pancreas AID system

Continuous ketone monitoring: Innovations and clinical applications

Making the case for time in tight range

Insulins

Inhaled insulin treatment for youth with T1D

Courtney Ackeifi, Ph.D., Senior Scientist at Breakthrough T1D speaks at the ADJUST-T1D trial update.

Look out for tomorrow’s article for an update on Cures research presented at ADA 2025!

It’s that time of year again: the American Diabetes Association’s (ADA) 85th Scientific Sessions is taking place from June 20-23, 2025. Scientists, healthcare professionals, and industry leaders will travel to Chicago, IL for the biggest annual diabetes conference in the world. Breakthrough T1D will be there to join the discussion about the latest-and-greatest advancements in type 1 diabetes (T1D) research, prevention, and care from the best and brightest in the field—including many researchers who have received funding from Breakthrough T1D.

Read on to learn more about what we’re looking forward to.

What we’re looking forward to

Cures

Improving Lives

Breakthrough T1D is a leader in type 1 diabetes research

Each year, Breakthrough T1D has an increasingly important presence at ADA. Our leadership and staff organize panel discussions, chair symposia, present research, meet with industry leaders, and host gatherings to promote collaboration. Breakthrough T1D staff from each of our priority areas—Research, Advocacy, and Medical Affairs—will be in attendance.

As leaders in T1D research, we broaden our impact at ADA by shining the spotlight on Breakthrough T1D-funded scientists and clinicians. We are incredibly excited to see the advancements we are making toward cures and improving the quality of life of people with T1D—through our funded research and beyond.

Updates coming your way

Be on the lookout for important updates post-ADA in the News and Updates section of our website, including news stories dedicated to Cures, Improving Lives, and Medical Affairs.

Check out on-site coverage from ADA on our social channels featuring Breakthrough T1D leadership. Also, Breakthrough T1D CEO Aaron Kowalski, Ph.D., will host a live Facebook Happy Hour on Monday, June 30 at 6 PM Eastern Time. Details to come.

We can’t wait to share the exciting research updates we’ll hear at ADA with our T1D community. This is all made possible through your continued support—thank you!

A meeting of the minds

This past week, Breakthrough T1D helped organize an event hosted by Member of European Parliament Tomislav Sokol, Ph.D., titled “Accelerating Breakthroughs to Address Unmet Needs in Type 1 Diabetes.” This meeting, a significant coming-together of Breakthrough T1D and European policymakers, focused on the role of the EU in addressing the needs of the T1D community and accelerating T1D breakthroughs.

The purpose of this meeting was to raise awareness of T1D and the urgent need for the accelerated development and approval of breakthrough therapies in the EU. Conversations between Breakthrough T1D and European policymakers homed in on barriers and opportunities to advancing cures—including cell therapies and disease-modifying therapies—in the EU to get them into the hands of people with T1D, faster. This was an important step in establishing an open dialogue between Breakthrough T1D and the EU Institutions about working together to address T1D globally.

“This event in the EU Parliament allows us to engage with important decision-makers to ensure that the research and policy environments are oriented in a way to accelerate development of T1D breakthrough therapies in the EU as we also do in other countries,” explained Campbell Hutton, Senior Vice President of Global Advocacy at Breakthrough T1D.

Attendees

Several Breakthrough T1D leadership and staff members attended the meeting, including Thomas Danne, M.D., Ph.D., Chief Medical Officer, Global; Sanjoy Dutta, Ph.D., Chief Scientific Officer; Lynn Starr, Chief Global Advocacy Officer, Carmen Hurtado del Pozo, Director, European Research; and Campbell Hutton, Senior Vice President of Global Advocacy.

Several Members of the European Parliament (MEP) in addition to host Tomislav Sokol, Ph.D., were in attendance. Other attendees included people with a lived experience of T1D, health staff from EU Member States, researchers in the EU, and other European diabetes organizations.

Dr. Dutta delivered a talk on the role of breakthrough therapies in transforming T1D. Dr. Danne moderated a panel to provide insight about unlocking the potential of cell therapies breakthroughs in the EU with T1D cell therapy researchers: Professor Lorenzo Piemonti, M.D., Director of the Diabetes Research Institute at Vita-Salute San Raffaele University and Associate Professor Francoise Carlotti, Ph.D., Head of the Islet Research Lab at Leiden University Medical Center. Finally, Lynn Starr closed with remarks about our shared global responsibility to work toward breakthrough T1D therapies.

Breakthrough T1D leadership and staff who attended the meeting.

When and where it took place

The event took place on June 5, 2025, in Brussels, Belgium, at the European Parliament.

Driving toward T1D cures in the EU and beyond

T1D is on the rise around the world, including in Europe. Recent publications by Breakthrough T1D staff and leadership brought attention to the rise in incidence and global T1D burden. We need to act now in conjunction with governments around the world—like the EU—to address the unmet needs of everyone around the world affected by T1D.

T1D cures, including cell therapies, are advancing through the clinical pipeline. Bringing awareness of T1D to the forefront—and educating key people on the progress we’re making toward cures—will be incredibly important for driving T1D research forward in the EU. This represents a critical opportunity for the EU to accelerate cell therapies faster than ever. As a global organization, Breakthrough T1D is collaborating with the EU government to help make this possible.

As the largest global funder of T1D research, Breakthrough T1D has provided funding to researchers across the world in addition to the EU. Right now, Breakthrough T1D is supporting €56 million in European initiatives, including 31 clinical trials—representing 19% of our funded research (including the U.K.). Breakthrough T1D has expert teams in research, medical, regulatory, and advocacy in Europe, meaning we are uniquely positioned to provide guidance on how the EU can strengthen its T1D efforts and collaborate on a global scale to drive T1D breakthroughs, especially in cell therapies.

Type 1 diabetes is a critical disease in Europe, and I was pleased to host an event for the T1D community and my colleagues in the European Parliament to learn about the unmet needs in T1D and how we can work together to accelerate breakthrough therapies in Europe to address those needs.”

Tomislav Sokol, Ph.D.

Member of the European Parliament

What Breakthrough T1D leadership is saying

Lynn Starr, Chief Global Advocacy Officer

“This meeting is critically important to bringing the unmet needs of the T1D community into the spotlight in the EU. Global advocacy for curative T1D research is essential to achieving Breakthrough T1D’s mission, and continued collaboration with EU policymakers will get us there faster.”

Lynn Starr

Chief Global Advocacy Officer

ADCES Sanjoy Dutta and Anastasia Albanese-O'Neill

“Cell therapies are accelerating through the clinical pipeline faster than ever. We need to act now on a global scale to ensure that people with T1D around the world can access these transformative therapies. This meeting is a significant step toward that goal.”

Sanjoy Dutta, Ph.D.

Chief Scientific Officer

Accelerating global action is paramount to our mission

Global problems require global solutions. This meeting served as a critical launching point for a continued partnership with the EU to fill gaps and address unmet needs for the T1D community. Building relationships and fostering long-term partnerships is critically important for reaching our common goal of bringing cures to people with T1D as soon as possible.

These important conversations between Breakthrough T1D and the EU government align with our Project ACT (Accelerate Cell Therapies) initiative to accelerate the development of cell therapies that do not require immunosuppression—for everyone with T1D in every country. In addition, through international Centers of Reference, Breakthrough T1D’s Medical Affairs team is developing expert clinical care centers that will be trained and ready to provide cell therapies to people with T1D once they become available. We are at the forefront of global action to prepare the world for curative cell therapies.

We are driving toward a future in which everyone with T1D—no matter where they are—has access to therapies, treatments, and care, bringing us closer to achieving our mission of a world without T1D. The more people we have working toward our mission, the faster we will get there.

Breakthrough T1D’s newest mission pillar, Medical Affairs, is bridging the gap between access to and adoption of T1D therapies. The establishment of this program is essential to Project ACT (Accelerate Cell Therapies): Breakthrough T1D’s initiative to accelerate the development of manufactured islet cell replacement therapies that do not require immunosuppression. The goal is to make sure that people with type 1 diabetes (T1D) can get these therapies as soon as they hit the market.

The field is moving quickly: people are becoming insulin-independent in cell therapy clinical trials. We are advancing towards the submission of the first-generation manufactured islet cell therapy that requires immunosuppression, Vertex’s zimislecel (VX-880). We are at a critical moment and need to act now to ensure that healthcare providers (HCPs) are ready to bring manufactured islet cell therapies into clinical settings.

Enter Medical Affairs

This is where Medical Affairs comes in. The team, led by Thomas Danne, M.D., Chief Medical Officer International, is working with the medical community to anticipate obstacles to getting manufactured islet therapies into clinics and find ways to overcome them now.

To accomplish this, Breakthrough T1D recently hosted two cell therapy workshops, convening multidisciplinary, international experts in islet cell transplantation to discuss a clinical roadmap for manufactured islet cell therapies—and how to ensure that clinical teams are in place and prepared to provide these therapies to people with T1D who qualify. By preparing now, we can get this first-generation therapy into the hands of people with T1D as soon as possible after regulatory approval.

The cell therapy workshops were hosted by Breakthrough T1D’s Thomas Danne, M.D., Chief Medical Officer International, and Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, Vice President of Medical Affairs.

Read on to learn more about the cell therapy workshops, the attendees, and what each accomplished.

Workshop #1: Who may benefit most from manufactured cell replacement therapies

Attendees

The first of the cell therapy workshops, held in late April, convened transplant surgeons, T1D clinicians and researchers, a member of Vertex’s leadership team, a member of Breakthrough T1D’s Participant Advisory Council to represent people with a lived experience of T1D, and Breakthrough T1D Vice President of Research Esther Latres, Ph.D.

The purpose of this workshop was to start developing a five-year roadmap to help guide the T1D care community to support the adoption of manufactured islet cell therapies in clinical care. The evidence-based recommendations will be vetted by a larger group of clinical experts, diabetes organizations, and people with lived experience with T1D to ensure there is broad agreement. The consensus document will ultimately be published to expand its reach.

This process will summarize the essential evidence that will help HCPs decide who may benefit the most from manufactured islet cell replacement therapies. These decisions will take into account the perspective of people with T1D and differences in age, hypoglycemia unawareness, or kidney health, to name a few. This can help HCPs better understand the benefits versus risks for manufactured cell therapies on a person-by-person basis—making sure that each clinical decision is made jointly to prioritize long-term health.

Workshop #2: Pilot workshop to develop international Centers of Reference for T1D cell therapy

Attendees

The second cell therapy workshop, held in early May, convened clinicians from various global medical institutions, including University of Minnesota Medical Center, University of Wisconsin Health Transplant Center, the Penn Rodebaugh Diabetes Center, University of Chicago Medicine, IRCCS Ospedale San Raffaele (Italy), Institute of Transplantation, Newcastle upon Tyne (United Kingdom), and University of Alberta (Edmonton, Alberta, Canada).

Additional attendees from Breakthrough T1D included CEO Aaron Kowalski, Ph.D., Vice President of Research Esther Latres, Ph.D., the Medical Affairs team, a volunteer, and a member of the Participant Advisory Council, who is a person living with T1D.

The objective of this workshop was to take the first step toward creating Centers of Reference for T1D manufactured cell therapies. “The initial purpose is to accelerate readiness of healthcare professionals to deliver manufactured islet cell therapies once they become available,” explained Dr. Danne. “…making such a treatment a success needs teamwork. Accredited Centers of Reference will not only deliver advanced T1D treatments but also serve as a training hub for professionals aspiring to become experts.”

This workshop focused on better understanding what potential Centers of Reference need to be successful. The attendees covered a range of topics: what an ideal T1D care team might look like, the education and training required for experts in T1D manufactured islet cell therapy, and career development for early-stage T1D professionals.

The goal is to prepare expert clinicians—who are already doing islet cell transplants—to bring manufactured islet cell therapies into clinical practice at their institutions and others, once they have regulatory approval. These centers will serve as a benchmark for best practices in T1D manufactured cell therapy, establishing a network of expert teams to make sure that everyone who can benefit from manufactured cell replacement therapy is given the opportunity to consider it.

What the experts are saying

“We need to build consensus and teamwork. When manufactured cell therapies exist, it’s going to take significant coordination between endocrinologists, transplant surgeons, and people with T1D to ensure as many people as possible are benefiting from these therapies.”

Jon Odorico, M.D.

Professor of Surgery and Director of Pancreas and Islet Transplantation at University of Wisconsin Health Transplant Center

“It’s going to be a significant problem if we have a cure but no one has access to it because no one can deliver it. We must work together—transplant surgeons, endocrinologists, researchers, everyone. It’s like building Cape Canaveral in anticipation of sending rockets into space.”

Peter Senior, MBBS, Ph.D.

Islet Transplant Endocrinologist, Professor in the Department of Medicine, and Director of the Alberta Diabetes Research Institute at the University of Alberta, Canada

This is just the beginning

Manufactured islet cell therapies are coming. We need teamwork to get these therapies into clinics so people with T1D don’t have to wait years to get them. This is why Breakthrough T1D is acting now: when the first manufactured islet cell therapy hits the market, multidisciplinary care teams around the world will be ready. These workshops—the first of many—will help accelerate the safe and effective integration of manufactured islet cell therapies into clinics.

“This way we will ensure that the medical community is ready to deliver manufactured cell therapies once they become more widely available.,” Dr. Danne said. Thanks to the hard work of the Medical Affairs team at Breakthrough T1D, this goal is in sight.

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.

Unmet needs of the T1D community: More work is needed

This article, titled “The Urgent Need for Breakthrough Therapies and a World Without Type 1 Diabetes”, was published as a commentary in Diabetes Therapy in early April 2025.

About the publication

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.

Daily life with T1D is still a challenge

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 bigger picture

The global burden of T1D

11
The average number of years of life lost for people with T1D globally.
21%
The percent decrease in mortality rate for people with T1D in the last 30 years globally, which is not distributed equally among everyone with T1D.

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”).

The impact of hypoglycemia

25-40%
Percent of people with T1D who experience hypoglycemia unawareness.
30%
Percent of adults with T1D who have a fear of hypoglycemia.

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’s vision for the future…

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.

…and how to make it a reality

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.

What comes next?

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.”

Stephen Karpen, PharmD

Senior Director of Regulatory Affairs at Breakthrough T1D

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.

T1D demographics: From today to 2033

This article, titled “We Are on the Verge of Breakthrough Cures for Type 1 Diabetes, but Who Are the 2 Million Americans Who Have It?”, was published in the Journal of Health Economics and Outcomes Research in November 2024.

About the study

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.

T1D stats: Now

2.07 million

Number of people in the U.S. living with T1D.

47

Average age of people living with T1D.

67%

Percent of people with T1D who are 20–64 years old.

19%

Percent of people with T1D who are over 65 years old.

47%

Percent of people with T1D who have commercial health insurance plans. Other coverage includes Medicare (30%) and Medicaid (15%).

T1D stats: 10 years from now

2.29 million

Number of people in the U.S. living with T1D (due to increase in T1D incidence and improved survival from devices).

49

Average age of people living with T1D.

33%

Percent increase in T1D population that aged 65 and older (mostly due to aging of the current T1D population).

38%

Percent increase in T1D population that is aged 10 and younger.

44%

Percent of people with T1D who have private/commercial health insurance plans. Other coverage includes Medicare (30%) and Medicaid (17.4%).

30%

Percent increase in T1D population who will use Medicaid.

What comes next?

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.” 

Lynn Starr

Chief Global Advocacy Officer at Breakthrough 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.

Breakthrough T1D volunteer Matt Varey trains for his Canadian coast to coast bike ride fundrasier

This May, Matt Varey, a key volunteer with Breakthrough T1D since 2001, will embark on an ambitious two-month-long, 7,500-kilometer cycling journey across Canada.

As Matt rides Coast-to-Coast for Cures in support of Breakthrough T1D, his goal is that his passion and drive will inspire people to give generously to make each day better for those living with type 1 diabetes (T1D) while driving toward cures.

Matt has held a series of key volunteer roles within Breakthrough T1D. He currently serves on both the Breakthrough T1D International Board of Directors as Vice Chair and the Breakthrough T1D Canada Board of Directors

Matt sat down with Breakthrough T1D Canada to share more about his motivations behind taking on such an ambitious fundraiser and why supporting the T1D community is so important to him.

You’ve been involved with Breakthrough T1D as a volunteer and board member for over 20 years. How did you first get connected with the organization?

Matt Varey: My relationship with Breakthrough T1D (then JDRF) started in 2001.  My job at the Royal Bank of Canada (RBC) transferred me to Toronto. At that time, we were asked to build a new Canadian business within the bank, and it entailed me and other leaders going across Canada and speaking to employees very passionately and credibly about what they were going to help build.

Banking is a human business based on trust. I had to get out of my introverted shell and talk to employees, so I would ask them, “Who are you as a person? I want to get to know you as a human beyond just work.” I had no idea what Breakthrough T1D (then JDRF) was at the time. And you’d hear from people about their kids or sports, but one or two people would get teary or speak with a crack in their voice. So, naturally, I would probe a bit and ask more, and they would tell me about their family member and their journey with T1D.

So, when I got back from this Canada-wide work trip, I learned about the Breakthrough T1D “battle of the banks” Ride and thought to myself, “Wow, I have to do this.” That spring, I was part of the RBC Ride team. I saw all these people raising money for T1D research, and I made this connection to the people I met along that work trip affected by T1D, and I got the bug. My mother always said, “What’s given is yours forever,” and I knew I had a new purposeful journey with Breakthrough T1D.

It all flowed from there. I became the chair of the RBC Ride Cabinet and then the National Cabinet Chair. I saw the power of progress; I saw the dedication and the passion of people. I said, “I can’t stop at the Ride.” And then I met a fabulous mentor, one of the most important people in my life, Peter Oliver.

Peter was one of the founding fundraisers of what was then JDRF Canada because of his daughter Vanessa, who lives with T1D. He was such a giving person, and he taught me things I will never forget about giving back. He told me, “Always think big, never take no for an answer.”

Peter was the definition of a mentor, about what Breakthrough T1D stood for and the people who worked there. And he knew that he had this young guy named Matt who would follow anything he asked. I’ve been a Board Member, Vice Chair, and Chair of Breakthrough T1D Canada, and I’ve never felt a culture of giving, togetherness, and dedication like I do from the people at this organization. This led me to being a board member of Breakthrough T1D International (headquartered in the United States), and now I am currently the Vice-Chair of Breakthrough T1D International.

This journey can be credited in so many ways to Peter, who was, is, and always will be my north star.

Coast to Coast for Cures map of Canada

How did you devise the idea for Coast to Coast for Cures?

Matt Varey: As I retired in the summer of 2024, I thought about something my mum always taught me: “Never stop moving and never let the old man in.” So, with mentors like my mum telling me to “keep moving” and Peter Oliver saying, “Make sure it’s big, make sure it stands out, and make sure it challenges you,” I came up with the idea for the event.

Riding across Canada for 57 days and 7,500 km coast to coast for a cause is doing something different, and honestly, it scares me, which is good. I also love Canada so much, so that’s part of my journey, too. And I knew RBC would always have my back. As a mission, values-based organization, they told me in my retirement that if I ever did anything for Breakthrough T1D, they would be involved and support me 100%.

I want to challenge myself and hold true to my mum and Peter. My wife said she would take two months off work, bring the dog, and drive behind me. My wife is my everything, and I could never do this without her.

And one evening I made a public proclamation that I was going to do this, and then there was no turning back.

What are you most excited about for the ride, both personally and for raising awareness of Breakthrough T1D and type 1 diabetes?

Matt Varey: The world is changed by your actions, not by your words. Human beings, deep inside, want to see people accomplish something that is hard but shows dedication. I think that it attracts human beings to be generous. If we’re going to be asking people to help us raise half a million dollars, they want to see your skin in the game.

I’m excited about seeing the generosity of people. I’m an optimist; I always believe tomorrow is going to be better than today. I’m excited to see Canada for two months with my wife and see my former RBC colleagues, whom I miss dearly.

Do you have a message for the Breakthrough T1D community?

Matt Varey: We will never ever stop moving forward for cures. Ever. And I am just one of thousands and thousands of incredibly dedicated volunteers who also wake up every day and say the same thing, with even more credibility than myself.

As Mary Tyler Moore, who lived with T1D herself, would say, “You can’t be brave if you’ve only had easy things happen to you.” And people who live with T1D are brave every day. So please know that my commitment to you is also to be brave. And we will never ever stop until we get to a world free from type 1 diabetes.

Editor’s note: This interview is an abbreviated version of one previously published by Breakthrough T1D Canada. Read the full interview here.

After months of unexplainable symptoms, Katie Howell was diagnosed with type 1 diabetes (T1D) last year at age 25. Read on to learn more about how she confronted her new reality and became the first participant in New York City to enroll in the DIAGNODE-3 clinical trial.

The unexpected diagnosis

Katie hangin’ out in NYC.

Katie Howell, a Mississippian-turned-New Yorker, has a wide array of hobbies: crafting pottery at her local ceramics studio, enjoying old movies in the theater, cozying up with a book in Prospect Park, and taking in the sun at Rockaway Beach. Katie moved to Brooklyn after completing a Master of Public Administration degree at the University of Tennessee, Chattanooga, and she’s thoroughly enjoying getting to know her new neighborhood.

Suddenly, things took a turn. Last year, Katie started experiencing symptoms of something unknown—for three months, she had no idea what was going on with her body. Then, in a moment of complete shock, 25-year-old Katie was diagnosed with type 1 diabetes (T1D). “Without a family history of T1D and without any health issues of my own, being diagnosed with a sudden, serious chronic illness could not have been more unexpected,” Katie explained.

At the time of her diagnosis, Katie was confronted with a flood of emotions. There was not a single person in her life that had T1D or could understand her experience. “…one of the most challenging parts of being diagnosed with a chronic illness is accepting it […]. This comes with a lot of hopeless feelings, and it is tough to surrender control to an incurable, pervasive, and expensive health condition,” Katie lamented.

Feeling alone and lost, she had no choice but to accept that she was dealing with a major life change—whatever that meant for the future.

Influenced

It wasn’t long before Katie took to social media to learn more about her diagnosis and connect with the T1D community. On Instagram, she stumbled upon Lauren Bongiorno, a T1D influencer. Ms. Bongiorno posted a video promoting DIAGNODE-3, a phase 3 clinical trial for the disease-modifying therapy Diamyd® for early-stage T1D.


Check out Lauren on Instagram: @lauren_bongiorno

Katie found that DIAGNODE-3 was enrolling at The Pediatric Diabetes Center at Hassenfeld Children’s Hospital at NYU Langone. After reaching out to the team at NYU, she realized that the stars had aligned: they had just opened enrollment, and after completing the necessary screening, Katie would be Participant Number One.

“It gets easier every visit!”

Katie received her first study injection in January and will get her third and final injection this month, followed by routine check-ins. This includes blood work, physical exams, and mixed-meal tolerance tests to measure her body’s ability to produce insulin.

As per the study protocol, Katie doesn’t know if she’s receiving the placebo or the study drug, Diamyd®. Still, she likes being in the study: she’s made meaningful connections with the trial team, has learned a lot about T1D, and feels that she’s making a difference—not just for herself, but also for biomedical research.

Katie’s biggest hurdles? Bloodwork and hospitals. “One challenge of this study is the routine blood work and being treated at the hospital. However, it does feel like exposure therapy. It gets easier every visit!” she exclaimed.

Finding her community

Since her diagnosis, Katie has made lasting relationships with others in the T1D community. She connected with the Greater New York Metro Chapter of Breakthrough T1D after volunteering at a Walk in NYC last fall. They introduced her to a group chat with other newly diagnosed young women, where they can ask questions, network, and learn from each other as they navigate their new realities.

Participate in clinical trials

Clinical trials are key to bringing medical advancements from the lab to the clinic. This wouldn’t be possible without brave people with T1D, like Katie, who volunteer to participate. These studies offer the potential for life-changing treatment and move the ball forward for the T1D community.

Use our Clinical Trials Matching Tool to find a trial near you. Connect with a Clinical Trial Education Volunteer in your area to learn more about trial participation and answer any questions you may have.