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Breakthrough T1D

Breakthrough T1D is a global nonprofit organization founded in 1970 by parents of children with type 1 diabetes (T1D) to fund research toward curing, preventing, and treating the autoimmune disease that destroys insulin-producing beta cells in the pancreas. Originally named the Juvenile Diabetes Foundation and later rebranded as JDRF to emphasize research, it adopted its current name in June 2024 to highlight "breakthroughs" in T1D management and potential therapies while dispelling the misconception that the condition affects only youth. Headquartered in New York with international chapters, the organization operates as a 501(c)(3) entity, raising funds through walks, rides, and donations to support grants, advocacy for public funding, and venture investments via its T1D Fund. Its mission prioritizes accelerating empirical advancements, though causal challenges in reversing autoimmune beta cell loss have limited progress toward a full cure despite substantial investments. Over 55 years, Breakthrough T1D has channeled billions into T1D research, claiming contributions to milestones like the HbA1c monitoring test, engineered insulins, continuous glucose monitors, insulin pumps, and automated delivery systems that improve daily management but do not address the underlying disease pathology. In fiscal year 2024, it raised $449.4 million, directing approximately 40% to research grants and leveraging additional private and public partnerships for $375 million more in therapy development, including cell therapies and the disease-modifying drug teplizumab (Tzield), which delays onset in high-risk individuals but offers no reversal for established cases. The organization advocates for increased federal funding through bodies like the Special Diabetes Program, yet critics note that amid these management-focused outputs, core cure-oriented efforts—such as beta cell regeneration or immune tolerance induction—have yielded no scalable clinical success, raising questions about allocation efficiency after decades of expenditure exceeding $2 billion.

History

Founding and Early Development

The Juvenile Diabetes Foundation (JDF), the predecessor to Breakthrough T1D, was established on May 28, 1970, in New York City by a group of parents whose children had been diagnosed with type 1 diabetes (T1D), including Lee Ducat, whose son Jay had developed the condition in 1969, along with Carol Lurie and Erwin Lurie. Motivated by the lack of progress in T1D research and the limitations of available treatments at the time, the founders aimed to accelerate scientific efforts toward a cure, emphasizing direct funding of biomedical research over general awareness campaigns. Initial operations were grassroots, relying on volunteer efforts and small-scale fundraising to support targeted grants, marking a departure from existing diabetes organizations that focused more broadly on both type 1 and type 2 diabetes. In its first years, JDF prioritized identifying and funding high-potential research projects, establishing itself as a catalyst for innovation in T1D management. By the mid-1970s, the organization had awarded its first grants, including support for the development of the hemoglobin A1c (HbA1c) test in 1976 by Anthony Cerami at Rockefeller University, which provided the first reliable measure of long-term blood glucose control and became the standard for assessing glycemic outcomes in clinical trials. This early focus on measurable scientific outputs helped build credibility, attracting additional donors and expanding the volunteer base, with chapters forming in major U.S. cities to coordinate local advocacy and fundraising. By the early 1980s, JDF had evolved into a more structured entity, renaming itself the Juvenile Diabetes Research Foundation (JDRF) to underscore its research emphasis, and had funded pivotal advancements such as the first genetically engineered human insulin (Humulin), approved by the FDA in 1982, as well as the inaugural commercial insulin pump developed in partnership with Medtronic. These achievements stemmed from strategic grant-making that bridged basic science and practical applications, with JDRF committing resources to islet transplantation research, including Paul Lacey's 1980s experiments in human recipients, laying groundwork for beta cell replacement therapies. Organizational growth during this period included international expansion and collaborations with entities like the National Institutes of Health, solidifying JDRF's role in directing over $1 billion in cumulative research funding by later decades, though early allocations remained modest and tightly focused on T1D-specific immunology and endocrinology.

Key Milestones in T1D Research Support

In 1971, the Juvenile Diabetes Foundation (now Breakthrough T1D) was founded by parents including Lee Ducat to accelerate research toward a cure for type 1 diabetes (T1D), initially funding early studies on disease mechanisms. In the 1970s, organization-supported work by Anthony Cerami led to the development of the hemoglobin A1c (HbA1c) test, which became the standard metric for assessing long-term blood glucose control and is required for diabetes drug approvals by regulatory bodies. During the 1980s, Breakthrough T1D funding contributed to the production of Humulin, the first recombinant human insulin approved by the FDA in 1982, marking a shift from animal-derived insulins and improving treatment safety. The organization also backed Paul Laczy's 1980 achievement of the first human islet cell transplant, laying groundwork for cellular therapies despite early limitations in longevity. In partnership with Medtronic, it supported the commercialization of the first external insulin pump in 1983, enabling continuous subcutaneous insulin delivery. The 1990s saw advocacy efforts secure the Special Diabetes Program (SDP) in 1998, which has provided over $3.5 billion in federal funding for T1D research through 2024, amplifying organizational grants. Breakthrough T1D research established causal links between hyperglycemia and diabetic retinopathy, informing preventive strategies. In the 2000s, the Edmonton Protocol, refined with organization input, improved islet transplant success rates in 2000, achieving insulin independence in select patients for up to a year. The launch of the Artificial Pancreas Consortium in 2006 fostered collaborative development of automated insulin delivery systems. Breakthrough T1D established the Network for Pancreatic Organ Donors with Diabetes (nPOD) in 2007, creating the world's largest T1D-specific tissue repository to study beta cell autoimmunity. Funded trials demonstrated continuous glucose monitors (CGMs) reduced HbA1c by 0.5-1% and hypoglycemia risk, driving insurance reimbursement. The 2010s brought FDA approval of Lucentis in 2010 for diabetic macular edema based on Breakthrough T1D-supported trials showing vision preservation. In 2016, the FDA approved the first hybrid closed-loop artificial pancreas system (Medtronic MiniMed 670G), resulting from organization-backed regulatory guidance and trials. Doug Melton's 2014 protocol for differentiating stem cells into functional beta cells advanced regenerative approaches. The T1D Fund, launched in 2019, raised over $800 million in venture capital for therapies like immunotherapies and encapsulation devices. Teplizumab trials, supported by the organization, delayed clinical T1D onset by an average of two years in at-risk individuals. Into the 2020s, the FDA approved teplizumab (Tzield) in 2022 as the first therapy to delay T1D progression in high-risk stages, based on organization-influenced studies. Lantidra, an allogeneic islet cell therapy, received approval in 2023 for adults with severe hypoglycemia unawareness, offering insulin independence to some recipients. Vertex Pharmaceuticals' VX-880 entered phase 3 trials in 2023, testing stem cell-derived islets with immunosuppression, enrolling patients toward potential curative outcomes. T1D Fund-backed Sana Biotechnology research demonstrated hypoimmune-engineered islets functioning without broad immunosuppression in preclinical models. Breakthrough T1D's cumulative exceeded $2 billion by , supporting over 180 active and 70 clinical trials at peaks, with direct expenditures reaching $121.5 million in fiscal year 2019. These efforts have indirectly leveraged additional billions through partnerships and wins like SDP .

Name Changes and Rebranding

The organization was established on November 6, 1970, as the Juvenile Diabetes Foundation by a group of parents, including Lee Ducat, whose children had been diagnosed with type 1 diabetes (T1D), aiming to fund research into the disease previously known primarily as juvenile diabetes. Over time, it adopted the name Juvenile Diabetes Research Foundation International, commonly abbreviated as JDRF, to emphasize its research focus while retaining the "juvenile" descriptor, which reflected the era's understanding that T1D onset was largely confined to childhood. In 2012, JDRF shifted to primarily using its acronym in branding and communications, effectively de-emphasizing the full name to broaden appeal beyond pediatric cases, as evidence mounted that T1D diagnoses occur across all age groups, with approximately 50% of new cases in adults by the 2010s. This adjustment aligned with internal recognition that the "juvenile" label no longer accurately represented the disease's demographics, though the organization retained JDRF legally and in formal contexts. On June 4, 2024, JDRF announced a comprehensive rebranding to Breakthrough T1D, introducing a new logo, visual identity, and tagline—"Accelerating life-changing breakthroughs"—to explicitly center its mission of advancing cures, prevention, and treatments for T1D while encompassing the full community affected by the disease. The change addressed persistent misconceptions perpetuated by the old name, such as the outdated view of T1D as exclusively a childhood condition, and aimed to enhance engagement with adult patients, researchers, and donors by signaling ambition and inclusivity; international chapters followed suit progressively through 2024 and into 2025. This rebrand was informed by community feedback and market research, maintaining continuity in mission and operations despite the shift away from the 54-year-old JDRF identity.

Mission and Strategic Objectives

Core Goals for Cure, Prevention, and Treatment

Breakthrough T1D's core goals center on accelerating breakthroughs to cure, prevent, and treat type 1 diabetes (T1D) and its complications, as articulated in its mission statement. The organization pursues a dual research framework: a Cures Program aimed at restoring insulin production and halting disease progression, and an Improving Lives Program focused on enhancing management and quality of life while awaiting curative advances. For curing T1D, Breakthrough T1D targets disease-modifying therapies (DMTs) to prevent onset, slow or reverse beta cell destruction, and achieve insulin independence through cell replacement or regeneration. This includes supporting clinical trials for immunotherapies that preserve residual beta cell function and stem cell-derived islet transplants, with the ultimate objective of functional cures that eliminate daily insulin needs without immunosuppression risks. Prevention efforts emphasize early detection of presymptomatic T1D via global screening strategies to identify autoantibodies in high-risk individuals, such as relatives of diagnosed patients, thereby enabling interventions to delay or avert clinical onset. Breakthrough T1D funds research into antigen-specific immunotherapies and metabolic modulators tested in trials like TrialNet, aiming to intervene before irreversible beta cell loss occurs, with evidence from studies showing potential delays in progression by years. Treatment goals under the Improving Lives Program seek to minimize complications through scalable technologies like automated insulin delivery systems, ultra-rapid insulins, and adjunct therapies for glycemic control, alongside behavioral interventions for mental health burdens such as diabetes distress. The organization prioritizes equitable access to these advancements, including efforts to reduce diabetic ketoacidosis at diagnosis and support precision medicine approaches tailored to individual immune profiles.

Evolving Research and Advocacy Priorities

Breakthrough T1D's research priorities originated in the 1970s with foundational efforts in basic science, including the development of the HbA1c test to enable long-term glucose monitoring. By the 1980s, focus shifted toward practical therapies, supporting the approval of genetically engineered human insulin (Humulin) in 1982 and the first insulin pumps, alongside early islet cell transplantation initiatives. In the 1990s and 2000s, priorities expanded to device innovations and federal funding mechanisms, such as backing the Special Diabetes Program (SDP) established in 1998, which has allocated over $3.5 billion to T1D research by 2024, facilitating advancements in continuous glucose monitors (CGMs) and artificial pancreas systems. The 2005 launch of the Artificial Pancreas Project marked a deliberate pivot toward automated insulin delivery technologies. The 2010s emphasized disease-modifying immunotherapies and regenerative approaches, contributing to the FDA approval of teplizumab (Tzield) in November 2022 as the first therapy to delay T1D onset in at-risk individuals, and supporting clinical trials for stem-cell-derived beta cells. Into the 2020s, priorities honed in on scalable cures, including Project ACT launched to accelerate cell therapy manufacturing and the progression of Vertex's VX-880 trial to Phase 3/2b by 2024. The organization's 2024 research strategy formalized two pillars: (1) accelerating therapies to cure or prevent T1D by prioritizing projects that modify disease course and reduce insulin dependence, and (2) enhancing quality of life via affordable drugs, devices, and behavioral interventions, with a preferential emphasis on late-stage clinical development. This framework targets high-impact outcomes over the 2024–2029 period through diversified portfolios, multi-disciplinary partnerships, and pipeline progression from discovery to commercialization. Annual research grants exceeded $100 million by fiscal year 2023, reflecting scaled investment in these areas. Critics, including the Juvenile Diabetes Cure Alliance, contend that historical expansions into complications, management tools, and non-cure elements have diverted resources from the founding cure-only imperative, potentially slowing progress despite official commitments. Advocacy priorities have long centered on sustaining the SDP, which Breakthrough T1D helped establish in 1998 and has advocated for successive reauthorizations, crediting it with enabling CGM efficacy studies and the first FDA-approved artificial pancreas in 2016. Early efforts focused on research funding and regulatory acceleration, evolving in the 2010s to address access barriers, including campaigns for Medicare coverage of CGMs approved in 2017. By the 2020s, priorities broadened to insulin affordability and innovation, influencing policies like the 2022 Inflation Reduction Act's insulin cost caps, alongside pushes for faster FDA pathways for hybrid closed-loop systems and early detection screening. In March 2025, the organization's Government Day mobilized advocates to urge Congress for SDP renewal through 2031 and enhanced NIH T1D allocations, emphasizing sustained momentum toward cures amid rising device adoption. The June 2024 rebranding reinforced advocacy integration with research acceleration, aiming to expedite therapy availability without altering core SDP and funding foci.

Organizational Structure

Leadership and Governance

Breakthrough T1D is led by President and Chief Executive Officer Aaron J. Kowalski, Ph.D., who assumed the role on April 9, 2019, following unanimous approval by the International Board of Directors. Kowalski, who lives with type 1 diabetes, oversees global strategies to accelerate research into cures, prevention, and treatments while advancing advocacy and technology development. The organization's governance is directed by the International Board of Directors (IBOD), which provides strategic oversight and ensures alignment with the mission to end type 1 diabetes. Lisa F. Wallack serves as Chair of the IBOD, elected on March 19, 2024. Supporting boards include the Global Mission Board, focused on research priorities and grant allocation, and the T1D Fund Board of Directors, which manages the venture philanthropy arm investing in innovative therapies. Executive leadership reports to the CEO and includes key roles such as Chief Financial Officer Maggie Morris, Chief Marketing Officer Pam Morrisroe, and Chief Legal and Risk Officer Jesse Raben, handling operations, fundraising, and compliance. Regional chapters maintain local boards of directors to support community engagement and fundraising, operating under the oversight of the international structure.

Global Operations and Chapters

Breakthrough T1D operates through a network of over 60 local chapters across the United States, which serve as hubs for community engagement, fundraising events such as walks, and support services for individuals with type 1 diabetes (T1D). These chapters, organized by state or region, facilitate local advocacy, education programs, and volunteer-driven initiatives to raise awareness and funds for T1D research. For instance, chapters in areas like Greater Wilmington, North Carolina, and Southern & Central Ohio coordinate events and provide resources tailored to regional needs. Internationally, Breakthrough T1D maintains operations via five key affiliates in Australia, Canada, Israel, the Netherlands, and the United Kingdom, which function as autonomous partners focused on funding research, policy advocacy, and community connection within their countries while aligning with the organization's global strategy. These affiliates have collectively invested significant resources in T1D projects; for example, the Australian affiliate supports over 50 active initiatives and has committed more than $266 million AUD since inception, including the Type 1 Diabetes Clinical Research Network with over 30 projects, while the Canadian affiliate funds 57 projects totaling $54 million CAD and supports 15 clinical trials. The Israeli affiliate has launched a $6 million initiative with the Israel Science Foundation, the Dutch affiliate has invested over €9 million since 2010, and the UK affiliate drives efforts like the Connect Immune Research partnership with organizations including Versus Arthritis. Following the organization's rebranding from JDRF in June 2024, these affiliates are transitioning to the Breakthrough T1D name to enhance unified global branding. Beyond affiliates, Breakthrough T1D's global operations extend to research funding and health equity initiatives across 21 countries, often through Centers of Excellence and partnerships that address access to screening, insulin, and devices in underserved regions. Key programs include the Type 1 Diabetes Index, which compiles global data on T1D prevalence, diagnosis, and treatment access, and the Early Detection initiative promoting population screening worldwide. In low-resource settings, such as Mozambique, the organization collaborates with networks like the NCDI Poverty Network to provide essential tools like glucometers, supporting individuals facing challenges including limited electricity access affecting 70% of the population. Governance for these efforts is overseen by the International Board of Directors and the Global Mission Board, ensuring coordinated strategy across borders.

Research Initiatives

Support for Device and Monitoring Technologies

Breakthrough T1D has invested extensively in advancing device and monitoring technologies for type 1 diabetes management, focusing on continuous glucose monitors (CGMs), insulin pumps, and automated insulin delivery (AID) systems to improve glycemic control and reduce complications. Since launching the Artificial Pancreas Project in 2005 with an initial $1 million donation, the organization has committed over $171 million through 2024 to related research, including more than 150 grants and 50 clinical trials that facilitated the commercialization of AID systems. This effort integrates CGM data with insulin pumps via algorithms to automate dosing, addressing the limitations of manual management. Early support included a $10 million, year-long CGM trial in 2006 that demonstrated efficacy in maintaining target glucose levels, paving the way for broader insurer coverage. A 2008 Breakthrough T1D-funded clinical trial further validated CGMs by showing reduced HbA1c levels and hypoglycemia rates compared to traditional finger-stick methods. The organization partnered with Animas (a Johnson & Johnson company) and Dexcom in 2007, providing $8 million over three years to develop a partially automated system linking insulin pumps wirelessly to CGMs. These initiatives contributed to the FDA approval of the first hybrid closed-loop AID system, Medtronic's MiniMed 670G, in September 2016. In recent years, Breakthrough T1D has funded innovations such as the Tidepool Loop app in 2023, an FDA-cleared software for AID using connected pumps and CGMs to automate basal insulin adjustments. It awarded grants in June 2023 to Integrated Medical Sensors for a continuous glucose-ketone monitoring platform and to Diatech Diabetes for software detecting insulin pump infusion set failures, enhancing device reliability. Support extends to implantable CGMs, including collaboration on Senseonics' Eversense system, approved by the FDA in 2022 for up to six months of use without frequent sensor changes. Advocacy efforts complement funding by pushing for regulatory approvals and access; Breakthrough T1D influenced FDA guidance on AID systems in 2012 and continues lobbying for renewal of the Special Diabetes Program, which has supported technologies yielding at least $50 billion in U.S. federal healthcare savings from 1998 to 2024 through better outcomes like increased time in range. The organization has backed hybrid closed-loop research for nearly 20 years, including studies showing 40-68% improvements in safe blood sugar levels for youth, and advocates for equitable access amid disparities in device adoption reported in October 2024.

Funding for Immunotherapies and Beta Cell Therapies

Breakthrough T1D allocates significant resources to immunotherapies aimed at modulating the autoimmune response in type 1 diabetes (T1D), including antigen-specific and broad-acting agents to preserve residual beta cell function or halt disease progression. As part of its strategic priorities, the organization supports research in autoimmune therapies alongside beta cell approaches, with immunotherapies integrated into its global portfolio of nearly 500 active grants. In February 2025, Breakthrough T1D provided USD 1.75 million in expanded support to Diamyd Medical for its antigen-specific immunotherapy targeting GAD65, building on prior collaborations to advance phase 3 trials. The T1D Fund, a Breakthrough T1D venture philanthropy arm with over $100 million in assets, co-invests in immunotherapy-focused companies, contributing to a portfolio where invested firms have raised $2.3 billion collectively, with roughly half directed toward immunotherapies. For beta cell therapies, Breakthrough T1D has committed over $230 million to cell replacement research since the 1980s, funding 246 projects focused on transplantation, stem cell-derived islets, and encapsulation to restore insulin production without lifelong immunosuppression. This includes initiatives like Project ACT, launched to accelerate regulatory pathways for cell therapy products as potential T1D cures through coordinated preclinical and manufacturing efforts. In August 2024, the organization issued a request for applications to leverage artificial intelligence in developing next-generation beta cell replacement therapies, aiming to enhance scalability and immune evasion. Recent publications, such as an August 2025 roadmap, outline standardized guidelines to expedite beta cell therapies from bench to clinic, emphasizing renewable cell sources and combination with immunoprotective strategies. The T1D Fund similarly splits investments evenly between beta cell therapies and immunotherapies, supporting companies like those acquired by Vertex Pharmaceuticals for stem cell-derived beta cell implants. In fiscal year 2024, Breakthrough T1D contracted 130 new grants totaling $92 million, with portions allocated to these curative pillars amid a broader emphasis on prevention and disease modification. These efforts complement advocacy for the Special Diabetes Program, which has secured nearly $3.4 billion in federal funding for T1D research at the NIH, indirectly bolstering immunotherapy and beta cell studies. Despite progress, challenges persist in achieving durable immune tolerance and scalable beta cell sources, prompting ongoing investments in hybrid approaches combining immunotherapies with replacement therapies.

Recent Projects and Emerging Therapies

Breakthrough T1D launched Project ACT, a coordinated initiative to accelerate the development and availability of cell therapy products as potential cures for type 1 diabetes (T1D) by addressing parallel challenges in research, clinical testing, regulatory policy, manufacturing, access, and medical adoption. The project includes funding for novel beta cell protection strategies, establishment of Centers of Excellence, development of clinical trial guidelines, and advocacy for expedited regulatory pathways. In fiscal year 2024, Breakthrough T1D allocated over 30 grants specifically toward cell therapy advancements as part of this effort, building on more than $250 million invested in over 300 cell therapy projects across 25 years. In August 2025, Breakthrough T1D published a paper outlining a roadmap for beta cell replacement therapies, emphasizing innovative clinical trial designs such as multi-arm and adaptive formats to hasten regulatory approval and broader patient access. The publication recommends expanding trial eligibility criteria—such as wider HbA1c ranges and reduced restrictions on severe hypoglycemia history—and incorporating patient-reported outcomes like quality of life metrics alongside traditional endpoints to better reflect real-world benefits for T1D patients seeking insulin independence. This framework aims to scale safe, off-the-shelf therapies capable of eliminating long-term insulin needs and reducing complications. Emerging cell therapies supported by Breakthrough T1D include stem cell-derived islets, which demonstrated insulin production restoration in a T1D patient in a 2024 study, and encapsulated therapies like Vertex Pharmaceuticals' VX-264, which received FDA investigational new drug clearance in 2023 for clinical trials. Additional progress involves Sernova's implantable device combined with cell therapies, showing insulin independence in trial participants as reported at the 2024 European Association for the Study of Diabetes (EASD) meeting. These approaches target immune protection for transplanted beta cells to enable durable function without lifelong immunosuppression. In disease-modifying therapies, Breakthrough T1D has backed trials of JAK inhibitor baricitinib, which preserved beta cell function in newly diagnosed T1D patients in 2023 results from the BANDIT trial initiated in 2020. The organization also supported extensions of teplizumab (Tzield), FDA-approved in 2022 to delay onset in at-risk individuals, with 2023 data confirming slowed progression in newly diagnosed cases. These efforts prioritize halting autoimmune beta cell destruction, with C-peptide levels validated in 2023 as a surrogate endpoint for trial efficacy. Breakthrough T1D's 2023 innovation grants further seeded high-risk, high-reward projects in these areas to advance toward prevention and reversal.

Advocacy Efforts

Campaign for Special Diabetes Program Funding

The Campaign for Special Diabetes Program Funding represents Breakthrough T1D's leading advocacy initiative to maintain and expand federal support for type 1 diabetes (T1D) research via the Special Diabetes Program (SDP), a congressionally mandated allocation to the National Institutes of Health (NIH). Established in 1997 following a Congressional Diabetes Research Working Group report on research gaps, the SDP directs $160 million annually—distinct from regular NIH appropriations—toward T1D-specific projects, including beta cell preservation, immunotherapies, and device innovations. Breakthrough T1D positions SDP renewal as essential, crediting it with enabling breakthroughs like hybrid closed-loop insulin delivery systems and estimating over $50 billion in federal healthcare cost savings through reduced complications, per an analysis by Avalere Health. Breakthrough T1D coordinates grassroots efforts, including volunteer-led calls and emails to lawmakers, to secure multi-year reauthorizations amid periodic expirations tied to budget reconciliation. A cornerstone is the biennial Children's Congress, which in 2025 convened over 150 delegates aged 4–17 with T1D to meet congressional leaders in July and September, emphasizing personal impacts and SDP's role in advancing therapies toward cures. These events build bipartisan support, as seen in prior renewals: a 2024 extension raised funding to $160 million from $150 million, followed by a six-month, $80 million bridge in March 2025. Funding lapsed on September 30, 2025, prompting intensified lobbying for bills like S. 2211, the Special Diabetes Program Reauthorization Act of 2025, introduced July 8, 2025, to extend and potentially enhance allocations. Breakthrough T1D urges supporters to contact senators for co-sponsorship, highlighting SDP's targeted efficacy over broader NIH grants, which have yielded approximately $3.55 billion in cumulative T1D investments since inception. Despite successes, delays risk halting ongoing trials and investigator awards, underscoring the campaign's focus on uninterrupted progress.

Regulatory Influence on FDA Approvals

Breakthrough T1D has actively partnered with the U.S. Food and Drug Administration (FDA) to streamline regulatory pathways for type 1 diabetes (T1D) therapies, particularly automated insulin delivery systems and disease-modifying immunotherapies. Through its Artificial Pancreas Project, launched in 2006, the organization collaborated with the FDA to develop guidance documents that facilitated pivotal clinical trials and approvals, addressing regulatory hurdles proactively rather than reactively. This effort culminated in the FDA's 2012 guidance for integrated continuous glucose monitoring and insulin delivery systems, which accelerated the path to market for hybrid closed-loop technologies. A landmark achievement was the FDA's approval of Medtronic's MiniMed 670G system on September 28, 2016, the first FDA-approved hybrid closed-loop artificial pancreas for individuals aged 14 and older with T1D. Breakthrough T1D's involvement, including funding over $110 million in related research by 2019, reportedly shortened the approval timeline by approximately five years compared to traditional processes. Subsequent approvals influenced by similar advocacy include the Tandem Diabetes Care t:slim X2 with Control-IQ technology on December 13, 2019; Insulet's Omnipod 5 on September 20, 2022; and Beta Bionics' iLet Bionic Pancreas System on May 22, 2023, expanding access to ages as young as six. These systems automate insulin dosing based on real-time glucose data, reducing user burden and improving glycemic control. By 2024, Breakthrough T1D's efforts contributed to roughly 15 FDA-approved T1D management devices entering the market. In the realm of immunotherapies, Breakthrough T1D advocated for and celebrated the FDA's approval of teplizumab (marketed as Tzield) on November 17, 2022, as the first therapy to delay the onset of stage 3 T1D in at-risk individuals aged eight and older with stage 2 disease. Clinical trials showed it extended the median time to diagnosis by about two to three years, preserving beta cell function temporarily. The organization's funding supported foundational research, and its advocacy emphasized the need for disease-modifying options beyond symptom management. Breakthrough T1D has continued pushing for expanded indications and similar therapies, including off-label explorations like baricitinib for newly diagnosed patients, while expressing concerns over FDA advisory committee rejections, such as for sotagliflozin adjunctive therapy in October 2024. These initiatives reflect a strategic focus on expediting approvals without compromising safety data from rigorous trials.

Initiatives on Insulin Pricing and Access

Breakthrough T1D has advocated for policies ensuring affordable insulin access for individuals with type 1 diabetes, emphasizing that such measures must not impede biomedical innovation essential for disease-modifying therapies. The organization supports capping out-of-pocket costs while preserving incentives for research into cures and advanced treatments, arguing that high prices deter adherence and exacerbate health disparities without addressing root causes like limited competition in insulin production. In 2022, Breakthrough T1D endorsed provisions in the Inflation Reduction Act that imposed a $35 monthly cap on insulin copayments for Medicare Part D beneficiaries, effective January 1, 2023, which applied to all insulin products regardless of manufacturer. This legislation marked a partial victory in federal efforts to curb costs for seniors and disabled individuals on Medicare, though Breakthrough T1D noted it left gaps for those with commercial insurance. Following the Act's passage, major manufacturers like Eli Lilly, Sanofi, and Novo Nordisk announced voluntary price reductions and $35 caps on out-of-pocket costs for uninsured or underinsured patients, actions Breakthrough T1D attributed in part to sustained advocacy pressure. Breakthrough T1D has prioritized the INSULIN Act, bipartisan legislation reintroduced in Congress as of 2024, which seeks to extend similar $35 or 25% of net price caps to commercial insurance plans, exempt insulin from annual deductibles, and mandate transparency in pharmacy benefit manager practices. The organization urged its passage after President Biden's 2024 State of the Union address highlighted insulin affordability, positioning it as critical for universal access without relying solely on manufacturer goodwill. As of March 2024, the bill remained pending, with Breakthrough T1D lobbying senators like Jeanne Shaheen and Susan Collins for advancement. Beyond legislation, Breakthrough T1D facilitated a 2023 partnership with Civica Rx and generic manufacturers to produce insulin at $30 per vial or $55 for five pens, available without eligibility restrictions starting in 2024, aiming to introduce competition and stabilize supply chains strained by patent expirations and manufacturing complexities. This initiative targeted broader access for all prescription holders, contrasting with patient assistance programs that often impose income or insurance barriers, though Breakthrough T1D cautioned that such efforts alone cannot substitute for systemic reforms addressing insulin's status as a century-old biologic with high production barriers. In August 2024, the organization welcomed Medicare drug price negotiations under the Inflation Reduction Act that further lowered select insulin costs, reinforcing its stance that affordability gains should align with investments in next-generation therapies.

Community Engagement

Educational and Support Programs

Breakthrough T1D maintains a range of educational resources designed to equip individuals with type 1 diabetes (T1D), families, and healthcare providers with practical knowledge for disease management. These include on-demand accredited modules for allied health professionals covering T1D pathophysiology, treatment strategies, and patient care best practices. Comprehensive resource guides address topics such as nutrition, school accommodations, complications prevention, and health insurance navigation, available in multiple formats including printable PDFs and online tools. Support programs emphasize community building and peer connection, particularly for newly diagnosed individuals. The Bag of Hope initiative delivers a kit with informational materials, emotional support resources, and access to counseling for children and families following a T1D diagnosis, distributed upon request through local chapters. Virtual educational series, such as chapter-specific webinars and the national Community Summits, feature expert-led sessions on real-world T1D challenges, including exercise management and daily coping strategies, with recordings accessible year-round for caregivers and newly diagnosed adults. Family-oriented initiatives foster in-person and hybrid support networks. Programs like T1D Connections enable monthly gatherings for families of children aged 5-11, combining supervised peer activities for kids with adult discussions on diabetes-related stressors, implemented through regional chapters since at least 2023. Similarly, family support events in areas like Long Island integrate caregiver forums with child-focused games and crafts to build resilience and shared experiences. School-specific advocacy tools assist parents in developing individualized education plans (IEPs) and 504 plans, providing templates and guidance for educators to ensure safe T1D management from preschool through higher education. Peer support extends to targeted demographics, including teens adjusting to diagnosis via dedicated online communities and resources tailored to adolescent challenges like independence and mental health. A volunteer-driven peer network connects affected individuals globally, offering one-on-one matching based on shared experiences to reduce isolation, with sign-ups available through the organization's platforms. These efforts collectively aim to bridge gaps in T1D self-management education, though participation varies by chapter and relies on volunteer coordination for scalability.

Youth and Family Outreach Events

Breakthrough T1D organizes the Children's Congress biennially, convening over 160 youth aged 4 to 17 living with type 1 diabetes in Washington, D.C., to advocate directly with federal lawmakers for increased funding toward T1D research and improved access to care. The 2025 edition occurred from July 7 to 9, featuring delegate training, Capitol Hill visits, and interactions with policymakers to emphasize the urgency of advancing therapies beyond insulin management. The Youth Advocacy Leader (YAL) program targets teens with T1D, training participants to articulate personal experiences and lobby for policy changes through local chapter activities, including volunteering at walks and community summits. Chapter-specific initiatives, such as the Youth Ambassador Program in the Greater New York Metro area, engage children and teens aged 5 to 18 in awareness-raising events that highlight Breakthrough T1D's mission to accelerate research progress. Family outreach includes Community Summits, which provide virtual and in-person educational sessions on T1D management, peer networking, and interactive experiences tailored for parents, caregivers, and children. Local chapters host events like T1D Family Days, exemplified by the Wisconsin chapter's June 28, 2024, gathering focused on education, connection, and recreational activities for entire families affected by T1D. Recurring virtual meet-and-greets for parents of children aged 5 to 12 further support family coping strategies through shared discussions. Additional resources, such as the Bag of Hope distributed to newly diagnosed children, contain practical tools and information to aid families during initial adjustment, distributed via local chapters nationwide. These events collectively aim to foster community resilience while reinforcing Breakthrough T1D's emphasis on research-driven outcomes over symptomatic relief alone.

Funding and Financial Management

Revenue Generation and Major Donors

Breakthrough T1D generates revenue primarily through four main streams: special events such as walks, rides, and galas; direct contributions including individual and planned gifts; investment gains from its T1D Fund and other endowments; and other income sources like government grants and partnerships. In fiscal year 2024 (ending June 30, 2024), total revenue reached $262 million, marking a 17% increase or $38 million rise from the prior year and the highest level since 2001. Direct contributions accounted for $107 million, up 33% from fiscal year 2023, while special fundraising events generated an equivalent amount, together comprising 81% of overall revenue. Investment income also drove significant growth, though exact figures for that category were not itemized in public summaries. The organization's fundraising emphasizes grassroots participation from the type 1 diabetes (T1D) community, with the vast majority of funds derived from affected individuals and families rather than large institutional or pharmaceutical contributions. Key events include the Breakthrough T1D One Walk, described as the world's largest T1D fundraising and community-building initiative, alongside cycling rides and chapter-based galas that collectively mobilize thousands of participants annually. These efforts are supplemented by leadership giving programs targeting transformative donations, which provide donors with exclusive benefits such as event access and updates on research progress. Breakthrough T1D leverages its core revenue to attract additional external funding, securing $375 million in fiscal year 2024 from nongovernmental organizations ($26 million), U.S. and international governments ($151 million), and industry partners ($198 million) to support T1D research initiatives. Specific major donors are not publicly disclosed in detail, consistent with privacy practices for many nonprofits, though top individual fundraisers for events like the Ride to Cure Diabetes have raised amounts in the $20,000 to $25,000 range per participant, such as Sharon Woods ($24,400 from 25 donors) and Dan Mendelson ($24,122 from 58 donors) in 2024. Corporate and philanthropic partnerships exist, but official statements indicate they form a minor portion of revenue compared to community-driven sources. The T1D Fund invests in biotech companies developing therapies, generating returns that bolster operational revenue without relying on named high-profile benefactors.

Expenditure Allocation and Transparency

Breakthrough T1D allocates the majority of its expenditures to program services aimed at advancing type 1 diabetes research, advocacy, and community outreach. In fiscal year 2024 (FY24), the organization reported total expenses of $238 million, with $104 million directed specifically to research grants, representing approximately 40% of its record $262 million in revenue. This marked the highest research grant allocation since 2013, though the percentage of revenue devoted to grants declined from 44% in FY23. Functional expense breakdowns in audited statements categorize costs into mission program services (including research and advocacy at $145.67 million in FY24), public education and outreach, management and general, and fundraising, with program services comprising the largest share. The organization emphasizes leveraging its funds to attract additional investments, reporting $146 million in direct research funding and investments in FY24, which helped draw $375 million more from public and private partners, totaling $521 million in support for type 1 diabetes therapies. Independent evaluators assess program spending efficiency positively, with CharityWatch assigning a 75% program percentage rating, indicating that 75 cents of every dollar goes to mission-related activities. However, critics such as the Juvenile Diabetes Cure Alliance have pointed to increasing fundraising costs (up 27% to support the revenue growth) and $178 million in unused cash reserves as potential inefficiencies in prioritizing direct cure-focused research. Transparency is maintained through annual publication of audited consolidated financial statements and IRS Form 990 filings, detailing functional allocations and enabling public scrutiny. Breakthrough T1D holds a 99% score and four-star rating from Charity Navigator, reflecting strong accountability metrics, and participates at the Platinum level with GuideStar (now Candid) for full financial disclosure. It is also accredited by the Better Business Bureau's Wise Giving Alliance, confirming adherence to standards for governance and financial reporting. These measures underscore a commitment to verifiable fiscal responsibility, though ongoing debates highlight varying interpretations of optimal allocation toward research outcomes.

Effectiveness and Criticisms

Measurable Impacts on T1D Management and Research

Breakthrough T1D has funded foundational research leading to advancements in type 1 diabetes (T1D) management technologies, particularly continuous glucose monitors (CGMs) and automated insulin delivery (AID) systems, which have demonstrably improved glycemic control. Landmark studies supported by the organization, such as those validating CGM efficacy, contributed to regulatory approvals and payer coverage, enabling broader adoption that reduced average HbA1c levels by approximately 0.5-1% in users compared to traditional fingerstick methods, as evidenced in clinical trials like the CONCEPTT study for pregnant individuals with T1D. These devices have also been associated with a 20-30% increase in time spent in target glucose range (70-180 mg/dL) for many patients, correlating with fewer severe hypoglycemic events. In the realm of insulin delivery, Breakthrough T1D's early investments in the 2000s, including a 2006 initiative for hypoglycemia prevention, accelerated the development of hybrid closed-loop systems, culminating in the FDA approval of Medtronic's MiniMed 670G artificial pancreas in 2016—the first such system to automate basal insulin dosing based on CGM data. Regulatory collaborations further shortened approval timelines by years, facilitating subsequent AID expansions that have improved overnight glucose stability and reduced user burden. An independent analysis by Avalere Health attributes at least $50 billion in U.S. federal healthcare savings to CGM and AID technologies enabled by Special Diabetes Program (SDP) research, which Breakthrough T1D advocated for, through diminished diabetes-related hospitalizations and complications like retinopathy and nephropathy. On the research front, the organization has directed over $2.2 billion in grants since 1970, supporting more than 75 clinical trials annually in recent years and attracting an additional $300 million in parallel funding in 2017 alone. Key outcomes include contributions to the Edmonton Protocol for islet transplantation in 2000, enhancing short-term insulin independence rates to over 80% in select patients, and foundational work on the HbA1c test in the 1970s, now the standard metric for assessing long-term glucose control in T1D trials. More recently, Breakthrough T1D-backed efforts influenced FDA approvals of teplizumab (Tzield) in November 2022, delaying T1D onset by an average of two years in at-risk individuals via T-cell modulation, and Lantidra in 2023, an allogeneic islet cell therapy achieving insulin independence in 21% of recipients at one year post-transplant. These milestones reflect progress in immunomodulation and beta-cell replacement, though sustained insulin independence remains limited to subsets of patients, underscoring ongoing challenges in scalability and durability. Advocacy for the SDP has secured over $3.5 billion in federal research funding by April 2024, amplifying direct investments and enabling large-scale trials that have advanced beta-cell regeneration and encapsulation technologies, with preclinical models showing restored insulin production in animal studies. While self-reported impacts dominate available data, external validations like FDA timelines and economic analyses confirm tangible benefits in management efficacy and cost offsets, despite no complete cure achieved to date.

Debates on Progress Toward Cure and ROI

Despite investing over $2.5 billion in type 1 diabetes research since its founding in 1970, Breakthrough T1D (formerly JDRF) has not developed a cure that restores insulin independence for patients, prompting debates on the pace of progress and return on investment (ROI). Critics, including the Juvenile Diabetes Cure Alliance (JDCA), contend that only a small fraction of funded projects advance toward a "practical cure"—defined as therapies enabling life without daily intensive management, potentially achievable within 15 years—with just 2% of active type 1 diabetes clinical trials targeting such outcomes as of 2023. The JDCA's analyses highlight that Breakthrough T1D's research grants, such as the 157 awarded in fiscal year 2024, rarely prioritize practical cure modalities like immune modulation combined with beta cell replacement, favoring instead longer-term or incremental management tools. Proponents within the organization argue that ROI is evident in leveraged funding and foundational advances, such as catalyzing over $449 million in additional public and private investments for therapy development in fiscal year 2024 alone, alongside contributions to continuous glucose monitors and automated insulin delivery systems that have improved daily management. However, skeptics question this framing, noting that in fiscal year 2023, only 44% of $224 million in revenue ($98 million) directly funded research grants, with significant undeployed reserves ($188 million in cash and investments) and a historical shift away from explicit "cure" promises in fundraising materials, dropping below 50% of events by 2025. The JDCA further critiques opaque practices in initiatives like the T1D Fund, launched in 2017 with over $100 million committed, where limited disclosure on investments and returns obscures measurable cure-oriented impact despite a venture philanthropy model aiming for royalties and reinvestment. Empirical challenges underpin the debate: type 1 diabetes involves autoimmune beta cell destruction, and while preclinical successes in stem cell-derived islets and immunomodulation therapies have accelerated—such as phase 1 trials showing insulin production restoration—scaling to durable, accessible cures remains elusive after decades, with patient frustration documented in clinical trial accounts. Community forums echo ROI concerns, with long-term patients decrying stagnant core outcomes despite management gains, attributing delays to research prioritization over aggressive cure pursuits. Breakthrough T1D maintains that high-risk investments in beta cell replacement and prevention are yielding "verge of breakthrough" results, but without independent audits tying expenditures to cure milestones, debates persist on whether reallocations toward practical cures could enhance efficiency.

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