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.
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.
Medical Affairs
Breakthrough T1D’s Medical Affairs program is bridging the gap between access to and adoption of therapies, treatments, drugs, and devices for T1D. To accomplish this goal, the Medical Affairs team is working on healthcare provider (HCP) education, development of clinical care guidelines, and clinical trial education and awareness.
Guidelines for cardiovascular and kidney disease in T1D
Presenter: Camila Manrique-Acevedo, M.D.; University of Missouri
Cardiovascular disease (CVD) risk has decreased in people with T1D over time, but it is still the leading cause of death in people with T1D, representing a critical unmet need.
Treatment recommendations and guidelines have largely relied on evidence from studies in T2D.
Dr. Manrique-Acevedo recommends lipid-lowering medication (like statins such as Lipitor®) to reduce LDL to target levels. Based on an observational study, this class of drugs can reduce CVD risk by 22% in people with T1D.
She also recommends lifestyle modifications, blood pressure management, weight management, and early and proactive screening for CKD.
Development of clinical guidelines is a priority of Medical Affairs. The guidelines presented here are not published and do not necessarily represent the consensus of experts in the field. However, Dr. Manrique-Acevedo started the conversation to standardize CVD clinical care for people with T1D, which currently remains an unmet need.
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.
Consensus guidelines highlight: Breakthrough T1D staff making an impact
Clinical adoption of CKM
Development and clinical adoption of CKM will be a crucial step toward preventing DKA in people with T1D. Thomas Danne, M.D., Ph.D., Chief Medical Officer, Global, convened an International Breakthrough T1D Consensus Group to report on the application and utility of CKM for people with T1D. The report was submitted for publication just before ADA 2025. During the Symposium titled “Continuous Ketone Monitoring – Innovations and Clinical Applications,” five members of the Breakthrough T1D Consensus Group chaired and presented on how the initiative will impact the clinical adoption of CKM. The presentations covered the basics of ketones, self-monitoring of ketone levels with CKM, new data emphasizing the potential of CKM impact, and the importance of shared decision-making between HCPs and people with T1D—all of which were outlined in the consensus document. Development of CKM consensus guidelines is a critical first step toward clinical adoption of CKM so the T1D community can benefit.
Scenes from the Symposium “Continuous Ketone Monitoring – Innovations and Clinical Applications”
Key takeaways
Guidelines for T1D management, especially clinical consensus guidelines that have been built by international experts, are key to advancing clinical adoption of the newest therapies, devices, and treatments for T1D and its complications. CKM consensus guidelines are coming soon!
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.
Education and awareness highlight: Breakthrough T1D staff making an impact
Supporting the role of women in the T1D clinical care team
Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, Vice President of Medical Affairs, participated in a panel discussion about women in diabetes professions. She gave an overview of her personal career journey, providing valuable insight into the benefits of mentorship, training initiatives designed for career growth, fostering leadership for women, and developing supportive networks. The panel highlighted disparities such as lower numbers of women attending conferences and occupying leadership roles in diabetes professions. By understanding barriers and amplifying the achievements of women in the diabetes workforce, we can foster a culture of inclusion, provide women with opportunities for visibility and leadership, and ultimately create a stronger care team for people with diabetes.
Precision medicine for T1D
Joshua Vieth, Ph.D., Senior Director of Research, co-hosted a panel discussion with Ulf Hannelius, Ph.D., MBA, Chief Executive Officer of Diamyd Medical, titled “Precision in Diagnosis, Power in Treatment: The Future of Type 1 Diabetes.” Stephen Karpen, Pharm.D., Senior Director of Regulatory Affairs, was a panelist. The panel also included Laura Jacobson, M.D. (University of Florida), Emily Sims, M.D. (Indiana University), Jason Gaglia, M.D. (Harvard University), and Alecia Wesner (person with T1D).
The panelists discussed a range of topics, including how precision medicine can change the treatment landscape for disease-modifying therapies and practical challenges that people with T1D will face, such as coverage of screening to determine eligibility for precision medicine-based therapies.
A significant focus of the panel discussion was clinical trial education and awareness. Recruiting for trials that may only work for a portion of people with T1D may prove difficult—and it’s critical that HCPs communicate why a certain therapy may or may not be a great fit for an individual. Additionally, the panelists suggested that clinical trial education should be built into training for diabetes specialists and endocrinologists so they can appropriately talk with patients and share the most important information. As Dr. Sims put it, we need a “precision approach to talking about precision medicine.”
Speaking on behalf of the perspective of people with T1D, Ms. Wesner stressed the importance of educating not only HCPs but the T1D population about clinical trials, including those based on precision medicine. She discussed the impact of communicating the emotional side of clinical trial participation to people with T1D and how their decision to volunteer could benefit the T1D community as a whole.
DiabetesMine #DData ExChange event
This event brought together researchers, industry partners, clinicians, and regulatory specialists to discuss a range of diabetes topics. Esther Latres, Ph.D., Vice President of Research, hosted a panel discussion with industry titled “Headway and Hurdles: How can Diabetes Cell and Gene Therapy Succeed?” The panelists discussed the promise of cell therapies and role of Breakthrough T1D’s Project ACT (Accelerate Cell Therapies) in making these therapies a reality for people with T1D, especially those that do not require immunosuppression. Getting the word out about our work toward curative cell therapies—and discussing solutions to the challenges we’ll face bringing them from labs and into clinics—is a cornerstone of Breakthrough T1D’s Medical Affairs strategy.
Esther Latres, Ph.D., Vice President of Research (right) hosts a panel discussion on cell therapies for T1D.
Breakthrough T1D Advocacy shout-out
Marjana Marinac, Pharm.D., Associate Vice President of Regulatory Affairs, participated in a panel titled “Influencing Health Policy in 2025: A New World Order?” The discussion focused on the policy and regulatory environment surrounding funding for diabetes research, including the critical importance of continued renewal of the Special Diabetes Program. The panel also discussed the need to emphasize the voices of people with T1D in developing cures.
Marjana Marinac, Pharm.D. (second from left) speaks on panel about health policy in diabetes.
Key takeaways
Education and awareness—from HCPs, to people with T1D, to researchers—is essential for clinical adoption of new therapies that can benefit the T1D community. At multiple events that Breakthrough T1D staff led or participated in, diverse audiences learned about precision medicine, health policy, cell therapies, and supporting women on T1D care teams.
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
Presenter: Hiddo Heerspink, Ph.D.; University Medical Center Groningen
Finerenone has proven effective in preventing progression of chronic kidney disease (CKD) in T2D.
The phase 3 FINE-ONE clinical trial, which is testing whether finerenone can prevent progression of CKD in people with T1D, is nearly complete. The treatment period is only six months.
The primary endpoint is change in urinary albumin-to-creatinine ratio (UACR), an indicator of kidney damage. UACR is being used as a bridging biomarker for this trial based on demonstrated effectiveness of predicting finerenone-driven kidney benefits in T2D.
This has reduced the treatment time—and therefore clinical trial length—by a significant amount. Shorter clinical trials mean people may be more inclined to participate, and HCPs need to effectively communicate this to interested volunteers.
This is also an important lesson in clinical trial design and the benefits of repurposing drugs for T1D that have already shown benefits in T2D.
Key takeaways
Shortening clinical trial timelines will be critical to getting groundbreaking therapies from clinical testing to people with T1D faster. We can learn lessons from treatments that work in T2D and repurpose them for T1D to make this possible. Encouraging HCPs to discuss shorter clinical trial options with interested trial participants will be essential to recruitment, which in turns moves trials along even faster.
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.
Cures
Breakthrough T1D’s Cures program focuses on early detection, disease-modifying therapies, and cell therapies with the goal of working toward effective cures for T1D.
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
Presenter: Michael Rickels, M.D. (University of Pennsylvania)
Zimislecel (VX-880) is a manufactured islet therapy that requires immunosuppression, infused into a vein in the liver in people with T1D who have impaired hypoglycemic awareness and severe hypoglycemic events.
The phase 1/2 clinical trial, which is part of the pivotal phase 1/2/3 FORWARD-101 trial, is complete. Twelve participants received a single infusion of a full dose of cells and were followed for at least one year.
All 12 participants achieved the primary endpoint, which was elimination of severe hypoglycemic events and HbA1c levels less than 7%. 10/12 (83%) participants are insulin independent.
All 12 participants demonstrated sustained insulin production as measured by C-peptide, reduced external insulin therapy use, and achieved greater than 70% time in range.
There were no serious adverse events. Mild to moderate adverse events were consistent with the immunosuppression regimen, infusion procedure, and complications from T1D.
Breakthrough T1D’s support for Doug Melton, Ph.D.—whose proprietary lab-created beta cells are now being advanced by Vertex—goes back decades, both via research grants and an investment from the T1D Fund: A Breakthrough T1D Venture.
6-month update on Sana Biotechnology’s immune-evasive islets
Sana’s donor-derived islet therapy engineered with Hypoimmune (HIP) technology can evade the immune system without immunosuppression.
These cells were implanted intramuscularly in a first-in-human study into a person with T1D with no measurable insulin production.
Six months post-transplant, this person is consistently making their own insulin, as measured by C-peptide levels. Yet, they still require external insulin therapy because they received a smaller dose of cells than the dose that would be required to achieve insulin independence. They did not experience any serious side effects, so the cells and procedure are safe and well-tolerated.
A Mixed Meal Tolerance Test (MMTT) confirmed that these cells are not only surviving but also responding to changes in blood glucose levels.
This is a promising first step toward a functional cure for T1D that does not require immunosuppression. Sana Biotechnology is planning on applying this technology to manufactured islets.
Sana has received support from the T1D Fund to advance their HIP technology in islets, and Breakthrough T1D continues to work closely with them.
A new transplantation site for autologous manufactured islets
Presenter: Hongkui Deng, M.D. (Peking University)
Cells derived from adipose tissue (fat) can be removed from a person and chemically induced in the laboratory to become islet cells.
Implantation of autologous manufactured islets into the sub-anterior rectus sheath in preclinical models of T1D improves glycemic control.
In humans, this implantation site is easily accessible by an ultrasound-guided needle.
In a first-in-human study, autologous manufactured islets were implanted into this site in a person with T1D. This person no longer needs external insulin therapy and has greatly improved blood glucose control. This person had also received a liver transplant and was taking immunosuppressants.
A new encapsulation device for immune protection of transplanted islets
Presenter: Nicolas Laurent, Ph.D. (Adocia)
Adoshell® is a novel islet cell encapsulation device that can shield islets from the immune system, meaning that immunosuppressants are not needed.
The hydrogel-based device is non-degradable, easily retrievable, and allows the exchange of glucose and insulin from the vasculature surrounding the device while excluding immune cells from encapsulated islets based on pore size.
This device showed promise in animal models, and human clinical testing is next.
Tom Bollenbach, Ph.D. presents on Breakthrough T1D-funded research at the Advanced Regenerative Manufacturing Institute.
Cell therapies highlight: Breakthrough T1D-funded research
Tom Bollenbach, Ph.D. (Advanced Regenerative Manufacturing Institute; ARMI) presented on challenges and solutions for large-scale manufacturing of islet cells. The goal is to generate scalable, automated manufactured islets that can be used by labs around the world to accelerate research progress using a unique, validated, and reliable cell source. Some challenges include ensuring the manufactured cells can survive shipment from the facility to research labs and maintain their insulin-producing capacity when they are used in different labs. ARMI is working with the Beta Cell Replacement Consortium to address these challenges.
Antonio Citro, Ph.D. (San Raffaele Hospital) presented his work on ensuring that transplanted islets have enough oxygen and nutrients (“vascularization”) to survive and function. Dr. Citro described an approach tested in animal models referred to as “natural scaffolds” in which all cells are removed from a donor organ, such as a lung, leaving behind blood vessel structures and other structural components. Islet cells can be injected and grafted onto this scaffold to create a mini organ of islet cells, which can then be tested for functionality before and after implantation.
Andrew Pepper, Ph.D. (University of Alberta) also presented vascularization strategies to increase the survival and functionality of transplanted islets. The implantation of a biomaterial under the skin will trigger the immune system and initiate a foreign body reaction, which results in the formation of blood vessels and structural components around the foreign object. Removal of the object leaves a hollow pre-vascularized core suitable for islet transplantation. This process can be optimized by using a biodegradable material, so no removal is required, and by the addition of “accessory cells” that help maintain a vascularized environment for islets.
Key takeaways
Cell therapies are making significant headway in clinical trials, and people receiving manufactured cells are becoming insulin independent. Researchers are tackling the biggest challenges for optimizing islet transplantation, including large-scale manufacturing, ensuring cell survival, and preventing detection by the immune system.
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
Presenter: Mia Smith, Ph.D., DVM (University of Colorado)
B cells are a type of immune cell that can activate destructive immune cells that facilitate autoimmunity in T1D.
B cells can become wrongly activated against insulin-producing beta cells due to converging dysregulation of factors that regulate immunity.
These cells represent another potential target for disease-modifying therapies in T1D.
Disease-modifying therapies highlight: Breakthrough T1D-funded research
Emrah Altindis, Ph.D. (Boston College) presented on the role of the gut microbiome in T1D. His studies found that people with T1D tend to have more inflammatory bacteria in their gut microbiome. Dr. Altindis and his team identified a particular bacterial population that can enhance T1D onset in animal models due to changes in immune cells that contribute to T1D autoimmunity. These studies provide insight into additional factors that can drive immune changes in T1D.
Laura Sanz Villanueva, MSc (St. Vincent’s Institute of Medical Research), who works in the lab of Breakthrough T1D-funded researcher Professor Thomas Kay, MBBS, Ph.D., presented on a mechanistic follow-up study to the BANDIT clinical trial. The Breakthrough T1D-funded phase 2 BANDIT study showed that baricitinib, a JAK1/2 inhibitor that prevents immune cell communication, can increase insulin production as measured by C-peptide in people with recently diagnosed T1D. The present study found that baricitinib can reduce the number of natural killer (NK) cells in the pancreas, which are involved in the autoimmune destruction of beta cells. These data provide valuable insight into the mechanism of baricitinib-mediated protection of beta cells.
Key takeaways
T1D is driven by dysregulation of the immune system, which results in an attack on insulin-producing beta cells. Researchers at ADA 2025 spoked about novel factors—including B cells, NK cells, and T1D autoimmunity triggers—that may contribute to immune cell dysfunction in T1D.
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
Presenters: Richard Oram, M.D., Ph.D. (University of Exeter), Leslie Lange, Ph.D. (University of Colorado), Aaron Deutsch, M.D. (Massachusetts General Hospital), Josep Mercader, Ph.D.(Massachusetts General Hospital) and Eimear Kenny, Ph.D. (Icahn School of Medicine at Mount Sinai)
Polygenic risk scores (PRS) estimate the risk a person has for developing a disease like T1D based on variations in different genes.
Ancestry is a major influence on PRS, particularly based on differences in genes that regulate whether the immune system can distinguish between “self” and “non-self.”
Most PRS models have been developed using data from European populations and have a limited ability to accurately determine risk in other ethnic groups, such as individuals of African and East Asian descent.
Potential applications of PRS include incorporation into screening to better understand T1D risk, ensure accuracy in diagnostic tests, and develop precision medicine-based therapeutic approaches.
Understanding how genetic diversity contributes to T1D
Presenters: Suna Onengut-Gumuscu, Ph.D. (University of Virginia), Dominika A. Michalek, MS (University of Virginia), Aaron Deutsch, M.D. (Massachusetts General Hospital), and Stephen I Stone, M.D. (Washington University School of Medicine), among others.
These talks highlighted several studies conducted in diverse populations to better understand the pathophysiology of T1D.
Work presented from Consortia, such as RADIANT, focused on rare and atypical forms of diabetes.
Controversies in CGM and benefits for early detection
Presenters: Peter Calhoun, Ph.D. (Jaeb Center for Health Research), Michael Kohn, M.D., MPP (University of California San Francisco), Nicole Ehrhardt, M.D. (University of Washington) and Tadej Battelino, M.D., Ph.D. (University of Ljubljana)
CGM use holds value in identifying progression in early stages of T1D prior to symptomatic onset.
There was a call to update the clinical guidelines so that the benefits of CGM can be maximized within the T1D community—including at early and later stages of T1D.
Integrating newer measures of blood glucose, like the glucose management indicator (GMI) and time in tight range (TITR), will be essential.
Contributions of CKM to early detection
Presenters: Ketan Dhatariya, MBBS, M.D., Ph.D. (Norfolk and Norwich University Hospitals), Lori Laffel, M.D., MPH (Harvard University), Jennifer Sherr, M.D., Ph.D. (Yale University), and Richard Bergenstal, M.D. (HealthPartners Institute).
It will be critical to explore whether ketone monitoring could help reduce the incidence of diabetic ketoacidosis (DKA) at stage 3 clinical T1D onset.
Early detection of rising ketones will be important for people with T1D to take action before DKA occurs.
Early detection highlight: Breakthrough T1D-funded research and awardees
Brigitte Frohnert, M.D., Ph.D. (Barbara Davis Center for Diabetes), co-investigator with Breakthrough T1D-funded researcher Andrea Steck, M.D., presented on the evolution of CGM patterns prior to stage 3 T1D. Their longitudinal approach, with CGM data collected at three-month intervals, successfully distinguished individuals who progressed to stage 3 T1D clinical onset from those who did not. This research suggests that CGM may be beneficial for predicting clinical progression of T1D.
Anette-Gabriele Ziegler, M.D. (Helmholtz Munich) was awarded the Harold Hamm Prize for Biomedical Research in Diabetes 2025, highlighting her important contributions on T1D screening in the pediatric population.
Barbara B Kahn, M.D. (Beth Israel Deaconess Medical Center and Harvard Medical School) received the 2025 Albert Renold Award, and her role model for women in science was highlighted at the Women’s Interprofessional Network of the ADA (WIN ADA).
Key takeaways
T1D arises in diverse ways across age groups and ancestries, complicating diagnosis and treatment. At ADA 2025, experts highlighted how genetic and clinical heterogeneity demands more inclusive strategies. Tools like CGM and CKM were highlighted for their potential to enhance clinical management in the early stages of T1D.
Jay Tinklepaugh, Ph.D., Senior Scientist, and Esther Latres, Ph.D., Vice President of Research, at Breakthrough T1D’s Islet Cells in T1D Workshop.
Breakthrough T1D’s Cures team making an impact
Sanjoy Dutta, Ph.D., Chief Scientific Officer, participated in a panel discussion titled “Encapsulation vs. Naked Cell Therapy—Immune Challenges and Beta-Cell Perspectives in Diabetes Treatment.” The panelists covered different approaches to preventing immune attack of transplanted islets, including gene-editing, in addition to pros and cons of different transplantation sites.
Esther Latres, Ph.D., Vice President of Research, and Jay Tinklepaugh, Ph.D., Senior Scientist, hosted a workshop immediately after ADA titled “Islet Cells in T1D.” Breakthrough T1D-funded researchers gathered from around the world to discuss cell therapy clinical trial updates, mechanistic insights into islet function, targeted delivery of therapeutics to beta cells, and optimization strategies for islet transplantation.
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.
Improving Lives
Breakthrough T1D’s Improving Lives program focuses on devices, insulins, adjunctive therapies, treatments for complications, and psychosocial interventions to improve the health and quality of life of people living with T1D.
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
Presenter: Ildiko Lingvay, M.D.; University of Texas Southwestern
People with T1D have self-reported that they decided to try GLP-1RAs for weight loss and improved glycemic control.
Real-world evidence suggests that GLP-1RAs have a clinically meaningful impact on weight and reduced insulin dose.
While GLP-1RAs are generally safe, some people have stopped use because of gastrointestinal side effects. These side effects are also seen in people with T2D and people without diabetes.
A review of SGLTi and GLP-1RAs in reducing chronic kidney disease (CKD) in T1D
Presenter: David Cherney, Ph.D.; University of Toronto
In the EMPA-KIDNEY trial that included non-diabetes participants and people with T1D or T2D, empagliflozin (SGLTi) improved kidney health in people with T1D.
In the ATTEMPT trial, dapagliflozin (SGLTi) improved time in range (TIR), reduced HbA1c levels, and had positive effects on kidneys in youth with T1D.
The Breakthrough T1D-funded enrolling phase 3 SUGARNSALT trial is testing whether sotagliflozin (SGLTi) can prevent progression of moderate to severe kidney disease in people with T1D, and it includes careful diabetic ketoacidosis (DKA) risk mitigation strategies.
The SEMA-AP trial found that semaglutide (GLP-1RA) increases TIR in people with T1D when used alongside an AID system.
The Breakthrough T1D-funded recruiting phase 2 REMODEL-T1D trial is testing if semaglutide (GLP-1RA) can improve kidney health in people with 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
Presenter: Klara Klein, M.D., Ph.D.; University of North Carolina
In the phase 1/2 SimpliciT1 study, people with T1D who received the GK activator TTP399 showed improvements in blood glucose with fewer hypoglycemic events.
A different study found that TTP399 does not increase the risk for DKA.
These studies were done in collaboration with vTv Therapeutics, a company with funding and support from Breakthrough T1D and the T1D Fund: A Breakthrough T1D Venture. The phase 3 CATT1 study for TTP399 is testing whether it can reduce moderate to severe hypoglycemic events in people with T1D.
Adjunctive therapies and complications highlight: Breakthrough T1D-funded research
Halis Kaan Akturk, M.D. (University of Colorado), Janet Snell-Bergeon, Ph.D., MPH (University of Colorado), and Viral Shah, M.D. (Indiana University) presented findings from the Breakthrough T1D-funded ADJUST-T1D clinical trial, which was recently published in the New England Journal of Medicine Evidence. The trial tested whether semaglutide (GLP-1RA) can improve glycemic and weight outcomes in adults with T1D and obesity who are using an AID system. 36% of people treated with semaglutide met the primary endpoints of TIR greater than 70%, time below range less than 4%, and weight loss of 5% or more compared to the placebo, and the drug was well-tolerated and safe. This trial represents critical evidence for use of a GLP-1RA as a potential way to manage both glycemic control and weight in people with T1D.
Ye Je Choi, MPH (University of Washington) reported on the CROCODILE study, which examined metabolic alterations in kidneys of people with T1D. She observed early structural and metabolic changes in kidneys that occurred before the onset of clinical kidney disease and associated structural damage. Her work could contribute to the development of biomarkers that can help predict the onset of kidney disease in people with T1D before it occurs.
Jeremy Pettus, M.D. (University of California at San Diego) conducted a phase 2 clinical trial to address insulin resistance in people with T1D. External insulin therapy can increase levels of insulin in the blood relative to glucose, which reduces sensitivity and may contribute to cardiovascular disease (CVD). Treatment with the glucagon receptor antagonist volagidemab, which prevents the liver from releasing glucose into the blood, reduces insulin requirements by 15%, resulting in improved glycemic control and insulin sensitivity without changes in bodyweight.
Schafer Boeder, M.D. (University of California at San Diego) worked with Dr. Pettus on a phase 1/2 clinical trial that tested whether the addition of SGLTi to the glucagon receptor antagonist volagidemab can further improve glycemic control in people with T1D. The combination of therapies increased TIR up to 86% from 70% and reduced daily insulin use by 27%. Further research is needed to better understand the safety profile of this regimen.
Justin Gregory, M.D. (Vanderbilt University) worked with Dr. Pettus and Dr. Boeder on the above study. He also presented on the use of GLP-1RAs and dual GLP-1/GIP receptor agonists for reducing complications in T1D.
Key takeaways
Clinical trials with GLP-1RAs and SGLTi are providing encouraging evidence about these therapies’ potential to improve long-term health in people with T1D. Breakthrough T1D is working toward a future where these drugs are an option for people with T1D to better manage their blood sugar and reduce complications.
Devices
Real-world insights from Automated Insulin Delivery (AID) systems
Presenter: David Maahs, M.D., Ph.D.; Stanford University
Based on published real-world evidence for AID systems in people with T1D, TIR is increased by an average of eight to 15% from baseline in a range of studies across various systems.
Youth with T1D have better glycemic control and reduced rates of DKA with AID systems. Those with lower TIR at the start of AID system use see the greatest improvements.
Real-world evidence: iLet Bionic Pancreas AID system
Presenter: Steven Russell, M.D., Ph.D.; Beta Bionics
The iLet Bionic Pancreas contains a continuously adapting algorithm that automatically determines insulin doses. No carbohydrate counting is required, and meals are only announced as breakfast, lunch, and dinner.
Data was collected from 16,000 users over two years.
Users achieved an average HbA1c level of 7.3%, down from 8.9%. This is accompanied by low rates of hypoglycemia and significantly improved self-reported quality of life.
Continuous ketone monitoring: Innovations and clinical applications
Presenters: Ketan Dhatariya, MBBS, M.D., Ph.D. (Norfolk and Norwich University Hospitals), Lori Laffel, M.D., MPH (Harvard University), Jennifer Sherr, M.D., Ph.D. (Yale University), and Richard Bergenstal, M.D. (HealthPartners Institute).
DKA rates are increasing in the U.S., but mortality rates from DKA are decreasing.
The history of continuous glucose monitoring (CGM) offers a roadmap for continuous ketone monitoring (CKM) development, showing how early skepticism gave way to broad clinical impact.
CKM could allow for earlier detection of rising ketones to prevent DKA. CKM also has the potential to identity infusion set failures, be a valuable addition to AID systems, help monitor early-stage T1D, and more.
Five new studies funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will develop CKM for safe and effective use of SGLTi in T1D.
Tandem, Beta Bionics, Sequel MedTech, and Ypsomed announced plans to integrate Abbott’s dual glucose ketone sensor into their AID systems.
Making the case for time in tight range
Presenter: Gregory Forlenza, M.D.; University of Colorado
Dr. Forlenza presented on the benefits and challenges of time in tight range (TITR), also known as time in normal glycemia (TING), defined as blood glucose levels between 70-140 mg/dL.
TITR will likely be more clinically beneficial than TIR as fluctuations outside of TITR may be better predictors of complications and offer a better therapeutic window for intervention.
More research is needed to advance therapeutics that will allow people with T1D to achieve TITR before it can be integrated into clinical decisions.
Devices highlight: Breakthrough T1D-funded research
Erin Cobry, M.D. (University of Colorado) presented the results of a Breakthrough T1D-funded clinical trial evaluating an artificial intelligence-powered AID algorithm designed to not require meal announcements. She showed that this algorithm (used without meal announcements) improved overnight TIR, and provided equivalent daytime TIR, compared to participants’ usual care. A major goal for Breakthrough T1D is to advance AID systems that do not require meal announcements to improve both glucose outcomes and quality of life for people with T1D.
Key takeaways
Devices have transformed how this disease is managed. Systems are becoming easier to use with less user input—and, critically, people with T1D are doing better. This is the dream Breakthrough T1D had when we launched the Artificial Pancreas project 20 years ago. We will continue to drive toward our goal of developing systems that provide superior health outcomes with minimal user burden.
Insulins
Inhaled insulin treatment for youth with T1D
Presenter: Michael Haller, M.D.; University of Florida
Afrezza® is an inhaled, fast-acting insulin that has proven to be effective in adults.
The phase 3 INHALE-1 study examined Afrezza® in youth with T1D. Users report greater treatment satisfaction and no increase in weight compared to injected rapid-acting insulin analogs.
Afrezza® is safe for youth with T1D. The most common adverse events were pulmonary-related, such as coughing.
Courtney Ackeifi, Ph.D., Senior Scientist at Breakthrough T1D speaks at the ADJUST-T1D trial update.
Breakthrough T1D’s Improving Lives team making an impact
Courtney Ackeifi, Ph.D., Senior Scientist, hosted an Improving Lives Happy Hour with Breakthrough T1D-funded researcher Jeremy Pettus, M.D. The discussion included research priorities for adjunctive (non-insulin) therapies for people with T1D and their healthcare providers. They also discussed the importance of industry partnerships and the role of Breakthrough T1D in driving these relationships, which can accelerate new T1D therapies toward the clinic.
Dr. Ackeifi also spoke at the ADJUST-T1D trial update, contextualizing the use of adjunctive therapies like GLP-1RAs for superior glucometabolic control in people with T1D.
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.
ADA’s 85th Scientific Sessions
This event is one of the largest diabetes conferences in the world, bringing together over 11,000 attendees to share and learn about cutting-edge research and advancements toward cures. Each year, Breakthrough T1D-funded researchers highlight their work, demonstrating the progress we’re making toward achieving our mission. Leading experts will present over 100 studies spanning cell therapies, disease-modifying therapies, diabetes technology, treatments, and more!
Sana Biotechnology’s phase 1 trial for UP421, a donor-derived islet therapy engineered to evade the immune system without immunosuppression
Strategies for improving islet cell manufacturing, transplantation, survival, and immune protection
Insights into immune mechanisms in T1D
Cures highlight: Breakthrough T1D-funded research
Several investigators from the Beta Cell Replacement Consortium will present updates on cell therapies research, and we’ll hear from Breakthrough T1D-funded researchers like Jeffrey Millman, Ph.D., on scaling up and optimizing manufactured islets.
Breakthrough T1D funded the phase 2 BANDIT study, which found that baricitinib, a JAK inhibitor, can preserve insulin production as measured by C-peptide. The team of Professor Thomas Kay, MBBS, Ph.D., will provide an update on what we learned from this trial.
Improving Lives
Adjunctive therapies, like GLP-1 receptor agonists, to improve blood sugar and reduce cardiovascular and kidney complications
Understanding risk factors, biomarkers, and underlying mechanisms of cardiovascular and kidney disease in T1D
Innovations in continuous ketone monitoring
Improving Lives highlight: Breakthrough T1D-funded research
Excitingly, we’ll hear the outcomes of the Breakthrough T1D-funded phase 2 ADJUST-T1D study, which tested whether the GLP-1 receptor agonist semaglutide (Ozempic®) can improve blood glucose control in people with T1D and obesity.
Breakthrough T1D-funded researchers will have a lot more to say about adjunctive therapies for T1D—including GLP-1 receptor agonists, SGLT inhibitors, and others—and how they can improve glucometabolic control and reduce complications. We’ll also hear updates from Erin Cobry, M.D., about an artificial intelligence-based fully closed-loop (no meal announcements) automated insulin delivery (AID) system in adults and youths with T1D.
Did you know that Breakthrough T1D had a hand in AID system development from the very beginning?
Check out this story from Breakthrough T1D volunteer Doug Lowenstein, who recounts the historical journey of AID systems becoming a reality for people with T1D.
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.
Breakthrough T1D leadership and staff paving the way
Sanjoy Dutta, Ph.D., Chief Scientific Officer, will co-chair a symposium with Mark Atkinson, Ph.D., titled “Cardiovascular Complications of Long-Term Diabetes: Type 1 vs. Type 2.”
Dr. Dutta will also participate in a panel discussion titled “Encapsulation vs. Naked Cell Therapy—Immune Challenges and Beta-Cell Perspectives in Diabetes Treatment.”
Esther Latres, Ph.D.,Vice President of Research, will host a panel discussion with industry partners titled “Headway and Hurdles: How can Diabetes Cell and Gene Therapy Succeed?”
Dr. Latres will also host a workshop titled “Islet Cells in T1D” after ADA, convening experts from around the world to dive deeper into cures research updates.
Joshua Vieth, Ph.D., Senior Director of Research, will co-moderate a panel discussion with Diamyd Medical titled “Precision in Diagnosis, Power in Treatment: The Future of Type 1 Diabetes.” Stephen Karpen, Pharm.D., Senior Director of Regulatory Affairs, will be a panelist.
Courtney Ackeifi, Ph.D., Senior Scientist, will speak at the ADJUST-T1D trial update.
Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, Vice President of Medical Affairs, will speak on a panel about women in T1D.
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!
Key Takeaways
Breakthrough T1D helped organize a meeting in European Parliament to bring the unmet needs of the type 1 diabetes (T1D) community to the forefront and discuss how we can accelerate cures, especially cell therapies, in the EU.
This meeting was attended by several Breakthrough T1D leadership and staff.
Building long-term partnerships with the European Union (EU) Institutions will allow us to work together toward global T1D cures.
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
“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
“International efforts to accelerate global adoption of T1D cures will become increasingly important as newer, emerging cell therapies become available to people with T1D. Conversations like these with EU policymakers is bringing this urgent need to the forefront.”
Thomas Danne, M.D., Ph.D.
Chief Medical Officer, Global
“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.
Project ACT
Scientific progress takes time, money, and effort. To accelerate islet replacement therapies faster than ever, Breakthrough T1D launched Project ACT (Accelerate Cell Therapies) to simultaneously advance research, development, regulatory policies, access, and adoption of manufactured islet therapies that do not require broad immunosuppression.
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
Key Takeaways
T1D leaders are working on a five-year roadmap for the clinical adoption of manufactured islet cell therapies.
It will include key criteria and evidence to help clinicians determine who is the best fit for manufactured islet cell therapies.
The guidelines are prioritizing shared decisions between people with T1D and their care team to optimize outcomes and maximize long-term health.
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
Key Takeaways
Centers of Reference are expert T1D care centers that are preparing to bring manufactured islet cell therapies to the T1D community.
This workshop was the first step to understanding what kind of education, training, and resources are needed for Centers of Reference to be effective.
Attendees discussed how to make sure people T1D who receive manufactured cell therapies at Centers of Reference will have the best clinical experience possible.
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.”
“We’re trying to solve access and awareness. There’s a definite gap between primary care endocrine diabetes specialists and transplant specialists…there’s so much more that we have to fill in for [people with T1D].”
Helen Nelson, BSN, RN, CCTC, CPTC
Program Manager, Organ Allocation/Clinical Triage and Pancreas Transplant Program 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
“There is amazing excitement around creating cell therapies. People are excited about it. We must ensure that organizations like Breakthrough T1D bridge the gap between research and the T1D population so that there is no difference between an individual’s reality and what therapies are available.”
James Shaw, M.D., Ph.D.
Transplant Endocrinologist and Professor of Regenerative Medicine for Diabetes at the Institute of Transplantation, Newcastle upon Tyne, United Kingdom
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
Despite major progress in T1D management, T1D still results in premature death, complications, and very significant daily burden.
Daily insulin use is a persistent challenge that comes with physical, emotional, social, and economic burdens.
New therapies and cures that can reduce or eliminate the challenges of living with T1D are closer than ever.
The entire T1D community (researchers, sponsors, clinicians, advocates, people with T1D, regulators) needs to work together to overcome scientific, drug development, and regulatory challenges to make cures for T1D a reality.
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.
Nearly 47% of Americans with T1D are enrolled in commercial health insurance followed by nearly 30% in Medicare, and 15% in Medicaid.
People with T1D who use diabetes devices have lower mortality rates than those who do not.
Most Americans living with T1D today are Non-Hispanic White people.
In the next 10 years, the Hispanic and African American populations with T1D are expected to grow the most, and the average age will increase from 47 to 49 years old.
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.
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 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.
I’ve never felt a culture of giving, togetherness, and dedication like I do from the people at this organization.”
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.
The world is changed by your actions, not by your words.”
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.
Visiting our site from Canada? Please click here to support Matt.
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.
“My advice to someone considering [the DIAGNODE-3] trial would be that, though the study is a commitment and an undertaking, they are taking part in discovering medical breakthroughs and T1D treatment research.”
Katie Howell
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.
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