What is the pipeline?
Every new medical device, therapy, treatment, and drug—including those for type 1 diabetes (T1D)—goes through the drug development pipeline. Getting a new therapy or device from the earliest stages of research eventually into the hands of people with T1D is a complicated process. Science takes time (from years to decades!), money (from hundreds of millions to billions!), and brainpower (lots and lots of brilliant scientists, doctors, researchers, and more)—and lots of it.
That’s what drives us and our work in the pipeline: people with T1D doing better.
This process is complex, to say the least. There are safety checks at every step of the way. Data are scrutinized, and preclinical and clinical testing must meet ethical standards. In fact, many new drugs and devices don’t make it very far in the pipeline—and those that do take a long time to get there.
Breakthrough T1D is unique in that we work across the entire pipeline—from start to finish—for every promising therapy or device that we invest in. Between Research, Advocacy, and Medical Affairs, we work at every single step to accelerate progress and get new treatments to people with T1D faster than ever.
That’s our value proposition. That’s what makes supporting us different than supporting an individual researcher, or a university, or a company.
Let’s dive a little deeper into the pipeline—and how we’re turbocharging it.
Time and money
Total money spent in the diabetes space in FY24:
$146 million
By Breakthrough T1D
$521 million
Total T1D research support, including by Breakthrough T1D
$160 million
By the Special Diabetes Program
$412.9 billion
In healthcare
Total investments in new drugs and devices:
12 to 15 years
Estimated time it takes a new drug to get to the clinic
$1 billion
Estimated total cost to bring a new drug from discovery research to the clinic
3 to 7 years
Estimated time it takes a new medical device to get to the clinic
$522 million
Estimated total cost to bring a new medical device from discovery research to the clinic
The pipeline in action: Automated insulin delivery systems
Automated insulin delivery systems vs. artificial pancreas systems
At the very beginning, these devices were called artificial pancreas (AP) systems. Today, they are called automated insulin delivery (AID) systems. We’ll be referring to them as AID systems going forward.
The process at a glance:
$171 million
The amount of money Breakthrough T1D spent on AID system-related research from 2005 to 2024
12 years
The amount of time it took for next-generation AID systems to go from discovery research to clinical adoption after Breakthrough T1D became involved
Hundreds of millions of dollars
Total investment in AID systems from all stakeholders
60+ years
The amount of time it took for AID systems to become a reality, starting with the first experimental AP system in 1964
A deeper dive into the process:
Breakthrough T1D x AID systems
Breakthrough T1D has played a significant role in the evolution of AID systems. Doug Lowenstein, a long-time Breakthrough T1D volunteer and supporter, detailed the history of AID systems from the very beginning, and how we accelerated progress at every step of the way.
Discovery research
It’s the early 2000s. I’m a new AID system, but I don’t exist yet—I’m just an idea. I live in the minds of some scientists and researchers who think that I have the potential to one day become a reality. But, turning an idea into reality can be hard. It’ll take a lot of people, time, and effort for me to exist—but it’s not impossible. The question is: how? Answer: it starts with funding.
2005: Breakthrough T1D launches the Artificial Pancreas Project
Breakthrough T1D dedicates funds to scientists and researchers who have compelling ideas to turn AID systems into a reality, marking the start of the decades-long Artificial Pancreas Project (APP). These investments were key in jump-starting research into all the components needed to make an AID system work.
“[The goal was] to keep people alive and healthy until we find a cure. We were losing people…overnight of low blood sugars. If we could automatically dose insulin and have everybody go to sleep and all wake up, that was an incredible victory.” -John Brady, member of Breakthrough T1D Executive Committee in the early 2000s, former Chair of Breakthrough T1D’s International Board of Directors, and father of a son with T1D
Translational research
It’s 2008. Scientists are making progress on the three key parts that need to work in harmony for me to become a reality: a continuous glucose monitor (CGM), an insulin pump, and an algorithm that lets them talk to each other. But, like most new ideas, before I’m allowed to be tested on humans, I need to be tested in animal models first. Lucky for me, I skipped this step because someone made a tool that could simulate how I would act if I was attached to a human being.
2008: Breakthrough T1D-funded scientists create simulator tool to bypass animal studies
The simulator tool, developed from the initial Breakthrough T1D grants, allowed scientists to model how an AID system would respond to real-life scenarios, like eating a certain amount of carbs or exercising, and how this would translate to blood sugar outcomes like time in range or hypoglycemic events. The FDA accepting the use of this tool was a major win—without animal studies, AID system development was accelerated by years.
“The simulator saved at least five years of animal studies because we didn’t require an algorithm to be tested in an animal model to be deemed safe and effective before going into human studies. That entire chunk was eliminated.” -Sanjoy Dutta, Ph.D., Breakthrough T1D Chief Scientific Officer
Clinical trials
It’s 2012. Scientists have come up with different versions of my components that are ready to be tested in humans. For the next four years, I’ll be attached to people with T1D around the world who courageously volunteered themselves to test if I actually work. Turns out, I do a pretty good job at managing blood sugar—and I’m safe!
2012 to 2016: AID systems make headway in clinical trials
While clinical trials for AID systems started in earnest in 2008, they kicked into high gear in 2012, when investigators started conducting trials using different AID components and algorithms in real-life settings. Progress moved quickly, and results from numerous studies supported the idea that AID systems are both safe and effective. Breakthrough T1D funding—along with the Special Diabetes Program—helped move these trials forward.
“Getting involved in AID system trials to me was my chance to pay it forward for somebody else. I have lived 45 years with T1D…I think there’s something comforting in knowing that my body was used for something that not only had the potential to make me healthier, but really was for other people. I do think there’s something to be said for doing good, feeling good, and this is what it felt like being part of trials.” – Alecia Wesner
Regulatory approval
Flashback to 2009. While scientists are busy figuring me out, people at Breakthrough T1D are already thinking about and planning for my future—and how to work with the decision-makers at the FDA who will ultimately decide my fate. The FDA has also given their two cents about the best ways researchers can test me in clinical trials to get the data needed for me to get approved. Fast forward to 2016, it finally happens: I get FDA approval!
2009 to 2016: From APP roadmap to FDA approval
In 2009, Breakthrough T1D published the AP Roadmap, detailing what the future of AID systems will look like—and how we plan to get there. Two years later, we worked with the FDA on clinical trial design for AID systems so that there was a clear path to approval. After human clinical trials, the FDA approved Medtronic’s hybrid closed-loop MiniMed 670G—officially marking the first AID system to be available in the U.S.
“I do give [Breakthrough T1D] credit for pushing, for saying there’s a real need for this.” -Jeff Shuren, M.D., Head of the Center for Devices and Radiological Health at the FDA at the time
Access
Flashback to 2008. At this time, people were still unsure if one of my main components—a CGM—was a reliable way to measure blood sugar. This all changed when a first-of-its-kind clinical trial showed that CGMs are better than finger pricks and glucose meters, and they were covered by insurance shortly after. This decision paved the way for my future: after my approval in 2016, insurers began offering to cover me.
2008 to 2017: Insurance coverage evolves
The landmark Breakthrough T1D-funded clinical trial in 2008 provided the data to convince private insurers to cover CGMs. Nearly a decade later, Breakthrough T1D launched its “Coverage2Control” campaign to advocate for insurance coverage of T1D treatments, therapies, and devices—including AID systems—ultimately resulting in all major private insurers offering coverage of AID systems by the end of 2017, followed by Medicare shortly after.
“Seeing the artificial pancreas go from concept to reality…is what makes Breakthrough T1D and all of the advocacy volunteers—who sent an email, made a call, signed an action alert, or met with their Member of Congress—very proud of this historic achievement and the impact that these will have on the individual lives of those with type 1 diabetes.” -Cynthia Rice, former Chief Mission Strategy Officer at Breakthrough T1D
Adoption
It’s present day. There are tons of iterations of me, and even more coming. People get to choose which version of me they like best. I’m covered by most health insurance. I’ve come a long way since I was just another thought in the minds of a few scientists who had a vision… and now I’ve come to life! Even so, not everyone has chosen to use me yet—and I will continue to evolve and grow until I can make the lives easier of as many people with T1D as possible.
2017 and on: More and more AID systems come to life
After the first hybrid closed-loop AID system was approved, the flood gates were opened. More and more systems are coming to market each year, and they keep getting better. They’re smaller, easier to use, and better at managing blood sugar. They’re covered by both government and private insurance plans. They’re an integral part of routine discussions between people with T1D and their healthcare providers, and people have options to choose which system is best for them. This is a future that was difficult to imagine two decades ago—and now it’s a reality. Even so, the work continues until AID systems are a reality for more and more people with T1D.
“What we brought to bear is resulting in a safer and easier life for hundreds of thousands, and soon millions, of people with T1D, including my son, that is going to keep them safe until something like a cure comes along,” -Jeffrey Brewer, one of the APP founders
The final stage: Cures and improved lives
It took tons of time, money, people, and effort to get us where we are today, but we’re not at the finish line yet. “The end game for AID systems,” says Breakthrough T1D CEO Aaron Kowalski, Ph.D., “is to have multiple compatible pumps, glucose sensors, and algorithms, so that patients can mix and match what they prefer.”
The end game for T1D as a whole, however, is cures. AID systems have greatly improved the lives of those with T1D—and will continue to do so now and in the future—while we continuously work toward cures that are one day available to everyone with the condition.
The path followed for AID systems is a roadmap for other therapies coming down the pipeline. Breakthrough T1D’s Project ACT is taking a page from the AP roadmap and applying it to cell therapies, so that functional cures can get to people with T1D who want them as quickly and safely as possible.
While I’m proud of my work as a scientist at Breakthrough T1D on AID systems (and my brother and I currently wear AID systems that are derived from Breakthrough T1D-supported work), more than anything else I want to take off my diabetes devices and achieve what our founders set out to do—find cures for T1D.”
Breakthrough T1D successfully took an idea and turned it into a reality—and we’ll do it again and again until T1D is a thing of the past.
Analysis compiled by Avalere Health and supported by Breakthrough T1D (formerly JDRF) finds that research funded by the Special Diabetes Program (SDP) has yielded more than $50 billion in federal healthcare savings.
Created by Congress in 1997 and administered by the National Institutes of Health (NIH), the SDP provides federal funding to support research to prevent, treat, and ultimately cure type 1 diabetes (T1D).
The Special Diabetes Program (SDP) is set to expire soon! Ask your Members of Congress to renew the SDP!
Working closely with the SDP’s champions in Congress—Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH) and Diana DeGette (D-CO) and Gus Bilirakis (R-FL)—Breakthrough T1D leads advocacy efforts supporting continued funding for the SDP.
The SDP has directly supported many of the most important innovations that have changed how T1D is managed—including continuous glucose monitors (CGMs) and automated insulin delivery (AID) systems.
Today, these technologies are the standard of care and are used more broadly, including by people with type 2 diabetes (T2D) contributing to improved health outcomes for people with T1D and T2D.
Understanding the SDP’s Economic Impact
To better understand the program’s economic impact, Avalere Health conducted an analysis of estimated federal cost savings associated with SDP-supported technologies.
The analysis focused on direct medical expenditures and modeled the savings resulting from the use of CGM and AID systems including savings to the tax-payer supported public insurance programs like including Medicare, Medicaid, and the Department of Veteran’s Affairs.
Avalere Health’s findings indicate that CGMs and AID systems alone have generated at least $50 billion in federal healthcare savings through improved glucose management and reduced diabetes-related complications.
The actual federal savings and total economic impact of these technologies is likely higher as the analysis does not account for indirect cost savings—such as improved productivity (such as, not having to take time off work to treat a low, etc.), reduced disability, or long-term prevention of complications.
CGM and AID 2024 utilization and savings, total federal savings from start of SDP
| Technology | Population Using Technology (2024) | Annual Savings Per Patient (2024) | Federal Savings By Diabetes Type (1998-2024) | Total Federal Savings (1998-2024) |
|---|---|---|---|---|
| Continuous Glucose Monitors (CGMs) Without AID | T1D: 749,700 T2D: 1,738,600 | $5,502 | T1D: $10.9 Billion T2D: $21.2 Billion | $32.1 Billion |
| Automated Insulin Delivery System (AID) | T1D: 780,300 T2D: 1,856,400 | $5,306 | T1D: $5.4 Billion T2D: $12.9 Billion | $18.3 Billion |
T1D therapies on that are on the market or currently in development have benefited from SDP-supported research in numerous ways, including:
- Clinical trials and technology validation for CGMs and AID systems
- Development of disease-modifying therapies, including Tzield, the first therapy approved by the FDA to delay the onset of insulin therapy dependence in T1D
- Development of advanced therapies for diabetic eye disease
- Early-stage beta-cell replacement research, including Lantidra, the first therapy approved by the FDA to place insulin-producing cells back in the body and ultimately reduce or eliminate the need for insulin therapy
The SDP’s Future
This study and existing literature confirm that the SDP has demonstrated a strong return on investment—both clinically and economically. The SDP has also made life with T1D more manageable. AID systems are now standard of care and they are leading to better outcomes with less disease burden.
Ongoing support for diabetes research and treatments will be essential to realizing the full potential of emerging innovations for individuals with diabetes
Disruptions in SDP funding may hinder clinical research infrastructure, delay scientific advancement, and slow patient access to therapies that reduce complications and lower overall costs.
As policymakers evaluate the future of the SDP in the debate over government funding stakeholders should consider how funding decisions will maintain or interrupt momentum in diabetes research, bringing advanced therapies to market, and how that will impact continued cost savings from improved health outcomes for people with diabetes.
Read the Insights & Analysis report and the full white paper on the Avalere Health website.
Editor’s note: Content for this story drawn from Avalere Health’s Insights & Analysis report.
Written by author and dedicated Breakthrough T1D supporter, advocate, and volunteer Moira McCarthy, pictured above with her daughter, Lauren
It’s now part of my morning routine, but not in the way most type 1 diabetes (T1D) parents would expect.
I grab my phone, open the continuous glucose monitor (CGM) app, and squeal with delight while wiping a strange salty substance from my eyes.
Because, just about every morning, I see something I thought would never be possible in my daughter’s 28 years of living with T1D: a perfectly straight line, totally in range.
It feels—and I not only don’t use this word lightly, but I’ve also never actually used it for a diabetes breakthrough before—transformational.
Starting a new T1D tool
My daughter, Lauren, diagnosed with T1D at age 6 and now almost 34, was late to the game when it came to automated insulin delivery (AID) system adoption. But, about three months ago, she–as her amazing adult endocrinologist kept telling me she someday would when she was ready–decided to give it a try. She chose one of the new, snappy automated insulin delivery systems as her newest tool after a seven-year pump break using pens and a CGM.
She was nervous. She’d experienced some tough years of burnout in the past and had long connected that with using a pump. She was hopeful, but skeptical.
It took her about 24 hours to realize this was truly worth it. And it took me about as much time to feel saved. Saved!
And here’s the cool thing: As long-time JDF, then JDRF, and now Breakthrough T1D volunteers, we absolutely saved ourselves.
That’s because, raising our hands from nearly the start (we attended our first Walk a year after her diagnosis), we were able to not only dream of what could be, but also make it happen.
There’s power and beauty in that, at a level I didn’t anticipate. And that’s the story I want to share. How we, just an average American family impacted by T1D, were able to lead, push, advocate, and win our way to access to smart devices like automated insulin delivery systems. We helped create a solution.
I should preface this with a fact: I’ve never been one to worry about my daughter. I attribute that to having raised her before technology and before the internet. We learned to trust and know that sometimes things go awry, but we can fix them.
But all T1D parents worry. Me? I worried about way, way down the road. Would she be okay in her midlife and later? I wasn’t sure.
Fueling breakthroughs from the ground up
Nearly 20 years ago, I was at an International Board of Directors meeting when then member Jeffrey Brewer had what I call his “pound the shoe on the table” moment. He offered $1 million with the stipulation that we, as an organization and as people passionate about a cure, also focus on creating technology to help people live better with T1D.
I was all in.
As National Advocacy Chair at the time, I helped our organization find funding and people for the original CGM trials. (Did you know no one else would do it, so we just did it ourselves with such great success that industry jumped on board?) We also fought for coverage—we literally found a person in every major insurance plan and filled out paperwork to get the first person covered in each, setting the precedent and swinging the doors open for all (well, almost all; insurance is a work in progress).
We did the Walks—our team, “Got Islets,” was one of the most successful in the nation. Then my daughter and I did the Rides, with our many friends continuing to donate after decades of us asking. Being directly involved gave me a voice in where funding went and how we focused our efforts. To me, tools that lessen the daily, hour-by-hour burden just made sense.
But, until a few months ago, it lived only in my imagination. While we’d always been early adopters (Lauren was the first young child in our state to go on a pump and one of the first in America to go on a CGM), as I said, it took time for her to be ready for this.
Little victories add up to big outcomes
Friends, it’s not a fever dream. This is real, and it’s spectacular. My daughter’s A1c fell quickly to nearly non-diabetic range. Her other labs are, as her endocrinologist said, “those of a person without diabetes.”
But more than that: She feels great! “Mom,” she told me the other day, “this sleeping all night thing? It’s pretty great!”
She feels more focused and refreshed—and since she works in advocacy fighting for coverage and treatments for Duchenne Muscular Dystrophy, that matters.
A Soul Cycle and Pilates enthusiast, she’s finally solved her workout dilemma. Before the automated insulin delivery system, her pattern was this: work out hard, crash low, eat all the carbs on the planet, marinate in remorse. Now? Activity mode works like a charm for her. No more blood sugar crashes, and way more workout satisfaction. Post-workout, she marinates in the feeling of success. The little things are the big things.
Finding our voice for powerful change
When we talk about my daughter’s improvements (and they’re such a big deal, we talk about them a lot!), we always go back to how we helped make this happen.
Like any long, long-term relationship, the organization and I have had our ups and downs. But I realize this: Had I not stumbled upon that Walk in 1998 (thank you, Marshall’s employee, for asking me if I wanted to give a dollar to help cure diabetes. Look what you did!), we may not have found our power, our voices, and our ability to bring positive change. And that feeling of having been a part of bettering her life firsthand? It’s incredible. We found power in what felt like a powerless future.
By the way, that “we” is more than my family. Every time I bump into friends who are long-time donors to this cause, I click on my phone, show them her in-range chart, and cry as I tell them, “YOU did this for us. YOU made this happen. I promised you every time you donated, I’d never just let your money go into a black hole. Here’s the proof. You did this for my kid.”
And me? An average suburban mom, given what seemed on day 1 to be an unbearable burden? Rather than give in to that, Breakthrough T1D helped me rise from it.
If you see me around, ask me to show you the graph I looked at that morning. When that salty substance leaks down my cheeks, know those are tears of joy.
And of thanks. We did what every parent dreams of: me, my friends, and Breakthrough T1D changed my child’s life for the better. This mom is over the moon. I cannot wait to see what the next generation of T1D parents and people living with T1D make happen. Because it’s truly in our hands.
We are our own solution. And from this view, that feels pretty darn great.
Your story matters
Living with T1D looks different for everyone. We want to hear your story: the highs, the lows, the challenges you’ve overcome, and the people who have supported you on your journey.
Continuous glucose monitors, or CGMs, have become increasingly popular with people who do not live with type 1 diabetes (T1D) as a way to observe the impact of activity and food on their blood-glucose levels.
While increased visibility of T1D technology can help normalize an advanced way to manage what is often an invisible condition, can wearing a CGM benefit people without T1D? Breakthrough T1D takes a look.
What are continuous glucose monitors?
Continuous glucose monitors are small, wearable devices that continuously measure a person’s blood-glucose levels. They are primarily used in place of glucose meters and finger pokes. A sensor just under the skin measures the glucose levels in real time. The levels are then relayed to a receiver, smartphone, watch, or insulin pump, which displays the readings.
How do CGMs benefit people living with T1D?
Continuous glucose monitors have been transformative for daily type 1 diabetes management. They have proven to:
- Lower HbA1c levels
- Reduce episodes of hypoglycemia (low blood sugar)
- Reduce the risk of complications associated with chronic hyperglycemia (high blood sugar)
- Increase time-in-range
Breakthrough T1D has played a pivotal role in the development and accessibility of CGMs for improved health outcomes in people living with type 1 diabetes.
In 2008, a Breakthrough T1D-funded clinical trial demonstrated the efficacy of CGMs in helping to manage blood sugar, with lower HbA1c levels and reduced rates of severe hypoglycemia in people living with T1D. This led to broader health insurance coverage and, ultimately, broader use of CGMs in the T1D community. The expansion of Medicare coverage of CGMs in 2022 also helped increase their use.
CGMs also have remarkable benefits during pregnancy with T1D. A 2017 study co-funded by Breakthrough T1D and the Canadian Institutes of Health Research showed that CGM use before and during pregnancy improves the health outcomes for both mothers and babies while reducing costs for neonatal hospitalization.
Today, eight CGMs are available in the U.S., and several are used in automated insulin delivery systems.
Unlocking access
Though T1D therapies like continuous glucose monitors are approved for use in the U.S., that isn’t enough. Breakthrough T1D tirelessly advocates for insurance coverage and the adoption of these therapies so that the entire T1D community can benefit from them.
Are there benefits to using a CGM if you don’t have type 1 diabetes?
For people without diabetes, CGM use is still considered investigational. “Early studies suggest CGMs may help detect abnormal blood sugar patterns in those with elevated risk—such as individuals who are overweight, have a strong family history of diabetes, or show borderline lab values—sometimes revealing glucose variability that standard tests might miss,” said Amin Ghavami Nejad, Senior Research Scientist at Breakthrough T1D.
There is also interest in using CGMs among athletes to monitor for exercise-related hypoglycemia and in exploring how blood sugar fluctuations may relate to cardiovascular risk. However, CGMs are not FDA-approved for individuals without diabetes, and there is no established clinical framework for interpreting the data in this population. More research is needed before CGM use in people without diabetes can be broadly recommended.
The role of continuous glucose monitoring in type 2 diabetes (T2D), however, continues to grow. The American Diabetes Association (ADA) 2025 Standards of Care recommended CGM use for adults with T2D who use insulin based on evidence that they improve glucose control, reduce hypoglycemia, and help patients make more informed daily decisions. The recent launch of Dexcom’s over-the-counter CGM, Stelo, also reflects rising interest in expanding access for people with T2D not using insulin and those with prediabetes, though this remains an evolving space and is not yet fully supported by clinical guidelines.
Breakthrough T1D will continue to support research in this area to accelerate therapies and access that can benefit those living with T1D and beyond.
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.
Adjunctive therapies and complications
There was significant focus on GLP-1 receptor agonists (GLP-1RAs) and SGLT inhibitors (SGLTi) in reducing long-term complications and improving glycemic control in people with T1D.
GLP-1 receptor agonists
Glucagon-like peptide 1 receptor agonists mimic the hormone GLP-1, which elevates insulin and regulates appetite. Examples include Ozempic® (semaglutide) and Mounjaro® (tirzepatide), which acts on both GLP-1 and a similar target, GIP.
SGLT inhibitors
Sodium-glucose cotransporter inhibitors target kidney cells to prevent them from reabsorbing glucose into the blood so it gets excreted as waste. Examples include Farxiga® and Zynquista®.
While SGLTi and GLP1-1RAs have proven effective for heart and kidney disease in type 2 diabetes (T2D) and in people without diabetes, people with T1D have often been excluded from critical trials. Thanks to years of advocacy and support from Breakthrough T1D, T1D trials are ongoing—and real-world evidence suggests that GLP-1RAs and SGLTi could be impactful in the T1D community as well.
Real-world evidence for GLP-1RA use in T1D
- 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.
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!
While we look back on 2024, we can reflect upon the incredible progress we’ve made in advancing breakthroughs toward cures and improving everyday life with T1D.
This wouldn’t have been possible without each and every one of you and your continued support of our mission as we drive toward cures for T1D.
Here are the top 11 advances that together, we made happen in 2024:
Breakthrough T1D announced the launch of Project ACT, an initiative aimed at accelerating breakthroughs in T1D cell replacement therapies that do not require broad immunosuppression. Recent advances, such as Vertex’s stem cell-derived islets, have been made possible by Breakthrough T1D’s Cell Therapies program as part of our drive toward cures. The goal of Project ACT is to push research, development, regulatory policies, access, and adoption to increase the rate at which cell therapies without the need for broad immunosuppressants will become available to people with T1D.
Why this matters: Immunosuppressive drugs are a barrier to access to cell replacement therapies because of their toxic side effects, which is why islet transplants are currently only available to people with severe low blood sugar (hypoglycemic) unawareness and episodes. By striving toward a future where we realize the benefits of cell replacement therapies without the downsides of the current regimen of immunosuppressants, we will make islet replacement therapies broadly accessible to the T1D community.
Vertex’s clinical trial of VX-880, a first-generation stem cell-derived islet replacement therapy for people with severe hypoglycemia (requiring the use of immunosuppressants), has transitioned into a phase 1/2/3, or pivotal, trial. This news comes after Vertex shared incredibly promising data in the earlier phases of the trial, including 11 of 12 participants reducing or eliminating the need for external insulin.
The upcoming trial will expand to 50 people who will get a single, target dose of VX-880. The primary endpoint will be insulin therapy independence without severe hypoglycemic events after one year. This is the final clinical testing stage before Vertex can seek FDA approval.
Breakthrough T1D has a decades-long relationship with Vertex and the leading scientists behind stem cell-derived islet therapies, an advancement that would not have been possible without Breakthrough T1D funding and support. The T1D Fund had invested in Semma Therapeutics, which was acquired by Vertex Pharmaceuticals in 2019, eventually leading to the active clinical development of VX-880 in T1D.
Why this matters: This is the first time a scalable cure for T1D is entering phase 3 clinical trials—a significant win and a huge step toward accelerating the delivery of cell therapies to members of the T1D community!
Tegoprubart: Transplant Survival Without Standard Immunosuppressive Drugs
Tegoprubart, an anti-CD40L immunotherapy that limits the immune response, is being tested in a Breakthrough T1D-funded study in people with T1D and severe hypoglycemia who have received deceased donor islets. Eledon Pharmaceuticals announced promising initial results in which two of three people achieved insulin therapy independence. According to the study, tegoprubart is safer for both people and transplanted cells in comparison to broad immunosuppressants, with milder side effects and greater islet survival. To further support this effort, the T1D Fund: A Breakthrough T1D Venture invested in Eledon.
Cell Pouch: A Home for Transplanted Islets
Breakthrough T1D has been supporting the development of Cell Pouch, an implantable device from Sernova that provides a safe, immune-protected environment for transplanted islet cells. In phase 1/2 clinical trials, all six people who received donor islets within the Cell Pouch achieved sustained insulin therapy independence with immunosuppressants, including long-term islet survival and function over five years without harmful side effects.
Why this matters: Standard of care immunosuppressive drugs that help avoid transplant rejection come with unwelcome side effects, such as increased risk of infection and malignancy and toxicity to kidneys, nerves, and islet cells themselves. Breakthrough T1D is focused on finding alternative ways to keep transplanted islet cells alive and healthy so that cell replacement therapies can become more tolerable and accessible.
In a major effort spearheaded by Breakthrough T1D, the first internationally recognized clinical guidelines for those who test positive for T1D autoantibodies have been published. These include guidance on monitoring frequency, education, and psychosocial support in addition to recommended actions for healthcare professionals (HCPs) when the risk of T1D progression is high. The guidelines were cooperatively developed with over 60 international experts spanning ten countries.
Why this matters: Previously, there had been no consensus on monitoring guidelines for people who test positive for T1D autoantibodies. Standardization of clinical recommendations means that individuals, families, and HCPs have tangible next steps to monitor early T1D progression and catch life-threatening complications sooner.
- Breakthrough T1D is leading a campaign to secure a recommendation for T1D screening from the U.S. Preventative Services Task Force (USPSTF), the main authority for preventative care. Approval would require T1D screening to be covered by insurance—an important step forward in expanding access.
- Driven by Breakthrough T1D’s advocacy efforts, The Centers for Medicare and Medicaid Services (CMS) established a unique ICD-10 code for stage 2 T1D. ICD-10 codes are used by HCPs to classify and document diagnoses, symptoms, and procedures. These codes provide a unified way for doctors and providers to indicate what diseases or conditions a person has in their electronic health record (EHR), empowering HCPs to document accurate diagnoses and provide the best possible care.
Why this matters: T1D early detection is critically important to prevent life-threatening complications at diagnosis and to give people necessary resources to make informed decisions about their health. Integrating T1D screening into the U.S. healthcare system will increase access to care.
The past year has seen some important advances in glucose management therapies and devices:
- Cadisegliatin, an activator of a blood sugar regulator in the liver, is being investigated in a phase 3 clinical trial (TTP399) as an adjunct therapy to insulin for people with T1D, although it is currently placed on clinical hold. vTv Therapeutics, the trial sponsor, is also a T1D portfolio company.
- The Omnipod 5 app is now available for the iPhone, making it easier to control the Omnipod without the need to carry a controller. It can also integrate with the Dexcom G6 continuous glucose monitor (CGM).
- Eversense 365 is the first FDA-approved year-round sensor that can easily integrate with automated insulin delivery (AID) systems. Other sensors require replacement after 10-14 days.
Why this matters: While advancements in glucose management have been pivotal in improving health outcomes for people with T1D, access remains a challenge. AID systems are globally underutilized, and not everyone has the necessary technology to connect devices. Breakthrough T1D is working to not only support advances in glucose management but also increase access.
Related content: While Breakthrough T1D consistently strives to improve the lives of those living with T1D, as an organization we have made incredible progress in the development of AID systems, also called the artificial pancreas systems. Read a historical perspective written by Breakthrough T1D volunteer Doug Lowenstein that covers conception to FDA approval of the first artificial pancreas systems, which changed the lives of people with T1D.
An inquiry spearheaded by the Breakthrough T1D affiliates in the U.K. uncovered risks of developing T1D eating disorders (T1DE), including bulimia, anorexia, or insulin restriction to lose weight. There is a significant gap in education and clinical guidelines for HCPs, a lack of internationally recognized criteria for T1DE diagnosis, and insufficient care integration, leading to preventable complications and healthy years of life lost. Breakthrough T1D recognizes the importance of spreading awareness and support for T1DE, and much work is needed to improve the lives of those living with T1DE.
Why this matters: There is an urgent need to change the way T1DE is approached, including integrated physical care with mental health services to get people with T1DE the access to care that they need.
In a study that included people with T1D, finerenone (Kerendia®) has been shown to improve cardiovascular outcomes in adults with heart failure. The drug is already approved in the U.S. to treat kidney and cardiovascular disease in people with T2D. Based on these results, Breakthrough T1D is supporting a clinical trial (FINE-ONE) in conjunction with Bayer to investigate the use of finerenone for T1D with the hopes of reducing kidney complications.
Why this matters: Kidney and cardiovascular disease remain significant challenges for those with T1D, especially given the FDA’s recent rejection of an SGLT inhibitor to lower blood glucose in people with T1D and chronic kidney disease. Yet, a new clinical trial (SUGARNSALT) will better assess the benefits versus risks.
Breakthrough T1D is advocating for the regulatory approval of C-peptide, a biomarker for insulin production by beta cells, to be used as an endpoint in clinical trials. An endpoint can accurately predict a meaningful benefit in clinical trials for disease-modifying therapies (DMTs; treatments that can slow, halt, or reverse T1D). To support this endeavor, Breakthrough T1D scientists and an expert consensus panel published research with evidence supporting C-peptide as an endpoint. Breakthrough T1D is continuing to engage with regulators, coordinate with industry, and assess more clinical trial data to drive this effort forward.
Why this matters: Current clinical trial endpoints (HbA1c, hypoglycemia, and complications) are not the best way to gauge the clinical benefits of T1D therapies. If C-peptide gets regulatory approval to be used as an endpoint, clinical trials could be smaller and shorter while still accurately assessing the advantages of a DMT. This means that drug development can move more quickly, and people with T1D will be able to access therapies sooner.
Related content: Two years ago, the T1D community received the incredible news that Tzield® had become the first FDA-approved disease-modifying therapy that can significantly delay T1D onset. Breakthrough T1D volunteer Doug Lowenstein recounts the life-changing drug’s journey nearly 100 years after the discovery of insulin.
The T1D Index is a data simulation tool that measures the global health impact of T1D, bridging gaps in our knowledge of public health statistics. T1D Index 2.0 has new and improved functionality, including advanced simulation capabilities, validation of data, and enhanced user experience. Breakthrough T1D contributed to both the development and improvement of the T1D Index.
Why this matters: The T1D index is critical in defining the intercontinental scope of T1D, driving us toward country-specific solutions and improved global health outcomes.
Earlier this year, JDRF rebranded to Breakthrough T1D. While our mission remains the same, our name needs to better reflect who we are and where we’re going. Our new brand aligns with our mission to accelerate life-changing breakthroughs for those of every age living with T1D as we work toward a world without it.
Why this matters: The proof is in the name—each day we strive to increase and accelerate breakthroughs in T1D, and it’s critical for our brand to accurately reflect our mission.
It’s certainly been an exciting year! While we still have more work to do, it’s crucial to celebrate our wins, both big and small, to see how far we’ve come in our push to make T1D a thing of the past.
Together, we’re accelerating breakthroughs for people with T1D, and the support of the T1D community drives our mission forward every single day, leading the way to lifechanging therapies and cures. Let’s see what 2025 has in store!
The American Diabetes Association’s 84th Scientific Sessions is here! Scientists will present the latest type 1 diabetes (T1D) research, from early detection to glucose control to complications, all with the goal of improving lives for the T1D community.
- In November 2022, the FDA approved Tzield™ (teplizumab-mzwv) for use in delaying the onset of clinical T1D. With the availability of a treatment option for people with Stage 2 T1D, the field has changed its outlook on delay and prevention and navigating pediatric T1D, especially in the early stages. Annette-Gabriele Ziegler, M.D., presented on several screening programs in Europe, including Fr1da, which has screened 200,000+ pediatric participants and found that it significantly reduces DKA onset at clinical diagnosis, and GPPAD, which identifies infants with an elevated genetic risk of developing T1D and enrolls them in primary prevention clinical trials. Andrea Steck, M.D., highlighted the value of CGM-based metrics in evaluating T1D risk and R. Brett McQueen, Ph.D., discussed the economics of early detection.
At-risk, or Stage 2 T1D, means that a person exhibited 2+ T1D-related autoantibodies—antibodies against one’s own self—and their blood glucose is starting to be abnormal, but they are not yet insulin dependent. When someone becomes insulin-dependent, they are in stage 3 T1D.
- We got updates on several automated insulin delivery (AID), or artificial pancreas, systems, including the:
- Medtronic MiniMed 780G, especially the importance of initiating it as soon as possible following diagnosis (which is now recommended in the ADA Standards of Care for both children and adults), citing the CLVer trial, which found clinically meaningful and sustained improvements in blood sugar management following early AID initiation.
- Medtronic MiniMed 780G in high-risk youth with T1D, with 80 participants aged 7-25 years, who demonstrated an average HbA1c reduction of 2.5% (from an average baseline HbA1c of 10.5% to 8%), improvement in time-in-range, and a reduction in low blood sugar events.
- Tandem Mobi among early pediatric and adult adopters.
- Sequel Med Tech’s twist AID system, which was FDA-cleared for people with T1D aged 2+ in March 2024. The system uses the DEKA Loop algorithm, which is based on the FDA cleared Tidepool Loop (iAGC) and is intended for use with compatible interoperable continuous glucose monitors (iCGMs). Sequel is Tidepool’s first publicly announced insulin delivery device partner with an FDA-cleared system that will integrate Tidepool Loop.
- In therapy, the full INHALE-3 results demonstrated the non-inferiority of inhaled insulin (Afrezza) used with insulin degludec compared to usual care. Baseline HbA1c was 7.6% across groups, and, on average, HbA1c in both groups remained stable from baseline to 17 weeks. Overall, 30% of the inhaled insulin group reached <7.0% A1c at 17 weeks compared to only 17% of the usual care group.
As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with the condition better while driving toward cures. We won’t stop until the condition is a thing of the past.
That means powering research to cure, prevent, and better treat T1D and its complications and ensuring that the entire T1D community has access to the tools they need to thrive.
Breakthroughs past, present, and future
For more than 50 years, Breakthrough T1D has played a pivotal role in nearly every major T1D breakthrough—from how HbA1c came to be more than 40 years ago to recent advancements like advanced T1D management devices, such as artificial pancreas (AP)/automated insulin delivery (AID) systems. Our work has also ensured that people have access to these advances.
Let’s have a look at some of the biggest breakthroughs we’ve advanced that are improving lives right now and those that promise to improve lives in the future.
The first disease-modifying therapy for T1D
In 2022, the FDA approved Tzield™ (teplizumab-mzwv) for use in delaying the onset of clinical T1D. This was the first disease-modifying therapy (DMT) for T1D to be approved. These are treatments that can slow, halt, or reverse the course of a condition. It took decades of Breakthrough T1D research for Tzield to reach approval.
Beginning with basic research by Kevan Herold, M.D., in the 1980s to preclinical and early clinical trials to a strategic investment from the T1D Fund: A Breakthrough T1D Venture that brought Provention Bio—the company that launched Tzield—into T1D for the first time, in 2017.
“The story with the clinical use of teplizumab began with a Breakthrough T1D grant to support a trial in patients with new-onset type 1 diabetes more than two decades ago. The success of this initial study planted a seed that led to further studies and support from the NIH.”
Kevan Herold, M.D.
Yale School of Medicine
But there’s a personal story, too.
Andy Drechsler and his wife Moira are the parents of four children; three of them have T1D. They have been involved with Breakthrough T1D since their son was diagnosed at the age of 22 months in 2005.
Andy’s professional life intersected with his personal life when he helped start Provention Bio in 2017.
“Everyone living with T1D provides us with great inspiration. We also appreciate the parents and caregivers of T1Ds. We are so happy to see the improvements in pumps and CGMs for those living with T1D. We are also thrilled to see therapies to delay the onset. Ultimately, we are confident that therapies will allow many to live without T1D someday.”
Andy Drechsler
Board of Directors President
Breakthrough T1D New Jersey Metro and Rockland County Chapter
We are moving ever closer to a world without this disease. Tzield is one gigantic step along the way, and others are right behind it. Read about the other disease-modifying therapies in our pipeline to learn about the drugs that could become the “next Tzield.”
T1D management devices—decades in the making
For 20+ years, Breakthrough T1D spearheaded efforts to develop artificial pancreas (AP) systems—also called automated insulin delivery (AID) systems. We would go on to fund more than 150 grants, including 50+ clinical trials, funded by us and backed by our Artificial Pancreas Consortium, to make the artificial pancreas system a reality.
Thanks to Breakthrough T1D research and advocacy efforts, approximately 15 FDA-approved T1D management devices are on the market today—more than half of them AP systems and the remainder, advanced CGMs and insulin pumps.
Read about the different AID systems that the U.S. Food and Druge Administration has approved in recent years.
“Witnessing the progression of T1D breakthroughs over the years has been nothing short of remarkable. When I first started insulin injections, it was a cumbersome routine, requiring multiple injections a day. Today, thanks to advancements in insulin pump technology, managing T1D has become more streamlined and efficient, improving my quality of life.”
Princess Padmaja Kumari Parmar
Breakthrough T1D Global Ambassador
Early detection empowers families, helps advance research
T1D develops in stages over time. Early detection identifies people who have early-stage T1D, but no symptoms, by a simple blood test. It looks for markers in their blood called autoantibodies. These autoantibodies signal that the body’s immune system is attacking the insulin-producing cells in the pancreas.
Autoantibodies also have value in identifying individuals who would later develop T1D, providing a new staging for presymptomatic T1D. The presence of two or more means that your lifetime risk of getting T1D is nearly 100 percent.
Early detection gives families time to plan and prepare before the onset of the condition, prevents life-threatening complications and hospitalization at the onset of symptoms. Critically, it also identifies at-risk people who can take advantage of preventive therapies—including disease-modifying therapies such as Tzield—or participate in clinical trials for T1D therapies being developed.
NFL Super Bowl Champion Orlando Brown, Jr., knows all too well how dramatically T1D can impact families, as his late father and his younger brother were both diagnosed with T1D.
In his role as Breakthrough T1D ambassador, the Cincinnati Bengals offensive tackle strives to educate people about T1D and the importance of T1D early detection and research. He also uses his platform to advocate for insulin affordability and policies like the Special Diabetes Program (SDP). Last summer, he was one of 10 Celebrity Role Models at Breakthrough T1D Children’s Congress.
Learn about our program, Breakthrough T1D Early Detection.
“The sudden loss of my father to diabetic ketoacidosis and my younger brother’s type 1 diabetes diagnosis at just 11 years old brought us face-to-face with uncertainty and the stigmas surrounding this condition. However, as we learned about diabetes devices and treatments to help manage the disease, we discovered a renewed sense of peace and hope. With more research, we believe we can ultimately end this disease. Knowledge is power and I’m sharing my family’s story to educate and inspire others who are living with type 1 diabetes.”
Orlando Brown, Jr.
NFL Super Bowl Champion
Breakthrough T1D Ambassador
Breakthrough in progress: stem cell-derived replacement therapies
Cell therapies replace beta cells in the bodies of people with T1D so that they can again produce their own insulin.
Biotech powerhouse Vertex Pharmaceuticals is making major headway in its goal of developing stem cell-derived replacement therapies for T1D. This work being advanced by Vertex has been supported by Breakthrough T1D for decades.
Vertex launched its clinical trial of VX-880, a stem cell-derived islet therapy in T1D for individuals with hypoglycemia unawareness, in combination with immunosuppressive therapy to protect the cells from rejection. Several people who have received VX-880 have been able to stop taking insulin.
This work was pioneered by Doug Melton, Ph.D., whose years of Breakthrough T1D-funded research led to successfully transforming stem cells into beta cells in 2014. A catalytic investment from the T1D Fund in Semma Therapeutics—the biotech company Melton founded to develop a stem cell-derived islet therapy for T1D—was followed years later by Vertex acquiring Semma. Vertex also acquired ViaCyte, which like Semma, had received support from Breakthrough T1D and the T1D Fund for its cell therapies research.
See the timeline of Breakthrough T1D’s support of stem cell-derived islet replacement therapies.
“My lab research has been for more than a decade or two, trying to cure type 1 diabetes. That might sound like an overly ambitious project, but I believe it’s a solvable problem. Our lab worked for years to figure out how to turn stem cells into functional beta cells. We can now make billions of functional beta cells.”
Doug Melton, Ph.D.
Vertex Pharmaceuticals Research Scholar
We are Breakthrough T1D
Breakthrough T1D is knocking on the door of something big. Giant leaps are happening nearly every day. You have gotten us to where we are today—and you can help us get to the finish line faster. So that you, your loved ones, and people everywhere can enjoy a world free from the burden of T1D. A world where people don’t have to manage their diabetes—don’t take insulin, don’t have blood sugar highs and lows, and don’t develop complications. With your ongoing support, we won’t stop until this condition is a thing of the past.
Learn More About Our New Brand.
Learn More About Our Organization.
JDRF’s vision is a world without type 1 diabetes (T1D) and in the past fiscal year, through many top type 1 diabetes advances, we’ve made incredible progress toward that goal.
Your support of our efforts is inseparable from the top type 1 diabetes advances we’ve seen in accelerating cures, improving lives, and advocacy wins for people with T1D and their loved ones.
As we approach the end of fiscal year 2023 (FY23), let’s highlight the many top type 1 diabetes advances we’ve seen.
Top Type 1 Diabetes Advance 1: First T1D Disease-Modifying Therapy
In a historic moment for T1D—and one that Breakthrough T1D had a hand in from the beginning, supporting research from the 1980s on—the U.S. Food and Drug Administration (FDA) approved Tzield™ (teplizumab-mzwv) for use in delaying the onset of clinical disease in at-risk individuals aged 8+.
For the first time in history, Tzield will treat the autoimmune process behind T1D, not the symptoms, altering the course of the disease.
Among our top type 1 diabetes advances, this is the first disease-modifying therapy—treatments that can slow, halt, or reverse the course of the disease—for T1D to be approved, but it won’t be the last.
Additionally, months after Tzield’s FDA approval, Sanofi acquired Provention Bio, the manufacturer of Tzield.
The acquisition brings the first T1D disease-modifying therapy available in the U.S. into the portfolio of a global leading pharmaceutical company, representing an endorsement of the potential of these types of therapies and, we hope, the opportunity to bring this life-changing therapy and others in the pipeline to more people faster.
Tzield and breakthroughs like it put us on the pathway to finding cures and, one day, preventing T1D entirely.
Top Type 1 Diabetes Advance 2: A Blood Pressure Drug Preserves Beta Cell Function
A Breakthrough T1D-funded study found that children and teens newly diagnosed with T1D who took verapamil—a drug already approved to treat high blood pressure—were making more insulin one year after diagnosis than those on placebo. In other words, in the children and teens who took verapamil, more beta cells were healthier one year post T1D diagnosis than those in the children and teens who took the placebo.
This was the second trial that found the drug can preserve beta cells in the newly onset period.
Additional studies may be needed to further validate the results, as well as identify all benefits and potential side effects of the drug. Breakthrough T1D has the strategy to answer these and other questions.
The finding brings us closer to our goal of having numerous disease-modifying therapies widely available for people with type 1 diabetes.
Top Type 1 Diabetes Advance 3: Affordable Insulins for Everyone
Breakthrough T1D and partnering organizations are supporting nonprofit pharmaceutical manufacturer Civica Rx to produce biosimilar insulin that will cost no more than $30 a vial/$55 a box of five pens, regardless of insurance status.
One year after the Civica announcement, Eli Lilly, Novo Nordisk, and Sanofi all announced reductions to the prices of their insulins—including the most used insulins, such as Humalog, NovoLog, and Lantus.
Another big win for insulin affordability was the $35 monthly out-of-pocket co-pay cap for those on Medicare included in the Inflation Reduction Act that Breakthrough T1D fought hard to secure.
In April, the Senate Diabetes Caucus Co-Chairs, Jeanne Shaheen (D-NH) and Susan Collins (R-ME), introduced the INSULIN Act of 2023, another key step toward achieving affordable insulin for all who need it.
The bill seeks to limit out-of-pocket insulin costs by ensuring that people with commercial insurance pay no more than $35 or 25 percent of the net price per month for at least one insulin of each type and dosage form, and includes other important provisions to help make insulin more affordable and accessible.
You can contact your members of Congress and encourage them to support the INSULIN Act of 2023.
Top Type 1 Diabetes Advance 4: Turbo Boosting Cell Therapies
Breakthrough T1D is working to develop and deliver life-changing therapies that place healthy, insulin-producing beta cells back into the bodies of people with T1D. There was a lot of progress in FY23.
Vertex, which previously acquired Semma Therapeutics, also acquired ViaCyte, bringing together the leading companies developing stem cell-based therapies for diabetes.
Vertex is advancing a stem cell-derived islet replacement therapy for T1D. It’s in human clinical trials and showing amazing results, with one participant being off insulin entirely.
Vertex also started a trial with a new product using encapsulated stem cell-derived islets as replacement therapy, and is exploring gene-edited stem cell-based therapies—both with the goal of eliminating the need for immunosuppressive drugs.
Just this past April, Aspect Biosystems—an industry leader in 3D bioprinting technology—and Novo Nordisk announced a partnership to expand the development of a new class of treatments for diabetes and obesity, using Aspect’s bioprinting technology and Novo Nordisk’s expertise in stem cell and cell therapy development.
The Aspect-Novo Nordisk partnership’s initial focus will be on developing bioprinted therapies for transplant that would be designed to maintain normal blood-sugar levels without the need for immunosuppression. This could represent a transformative treatment for people living with T1D.
Additionally, the U.S. Food and Drug Administration (FDA) approved CellTrans’s Lantidra™, the first cell therapy to be authorized in the United States, for use in adults unable to approach average blood glucose levels due to current, repeated episodes of severe low blood sugar. This therapy, which requires the use of immunosuppressive drugs, takes deceased donor islets and places them into people with T1D suffering from repeated severe low blood-sugar, called hypoglycemia, events. This is an exciting first.
Approved! Numerous T1D Management Technologies
Breakthrough T1D funds research to facilitate the development of new therapies and technologies to make day-to-day life with T1D easier, safer, and healthier. In the past year, we saw:
Newly-Approved Artificial Pancreas (AP) Systems and Algorithms
- iLet® Insulin-Only Bionic Pancreas System for ages 6+
- Medtronic MiniMed™ 780G AP system for ages 7+
- Tidepool Loop, an algorithm that will allow for interoperability of continuous glucose monitors (CGMs) and insulin pumps
Newly-Approved Continuous Glucose Monitoring (CGM) Systems
- Dexcom G7® CGM system for ages 2+
A New Tool to Accurately Diagnose Type 1 in Adults
Misdiagnosing adults with T1D as having T2D is an all-too-common problem that can have tragic consequences. Breakthrough T1D and IQVIA teamed up to develop an algorithm using artificial intelligence to examine medical records and identify individuals who were diagnosed with T2D but actually have T1D. This could be used in real time to correct misdiagnoses, offering the potential for future development into a clinical decision support tool.
A First-of-its-Kind Lifesaving Tool: The T1D Index
Breakthrough T1D and other T1D-related organizations launched the T1D Index, a first-of-its-kind data simulation tool that offers the most accurate estimate of T1D ever created. The Index measures and maps how many people live with this condition in every country, the healthy years of life it takes from people living with T1D, the number of people who would still be alive today if they hadn’t died prematurely from T1D complications, and our global strategy to reduce the impact of T1D.
Go Forward
Your partnership has been crucial to these advances and many more. On behalf of our community, thank you for moving us forward and ever closer to a world without T1D.
We are excited for the top type 1 diabetes advances that fiscal year 2024 (FY24) will bring!
Read Past Blogs about Top Type 1 Diabetes Advances:
What We Can Be Proud of in 2022
What We Can Be Proud Of in 2020
Top 10 T1D Breakthroughs of 2019
Cynthia Rice, Breakthrough T1D’s Chief Mission Strategy Officer, will leave behind quite a legacy once she steps down from her role at Breakthrough T1D at the end of March 2023.
“In her time with Breakthrough T1D, she has led with strategic purpose and passion,” read Breakthrough T1D CEO Aaron Kowalski’s December 2022 memo announcing Cynthia’s decision to leave. “She has been an incredibly valuable partner to me, as well as staff and volunteers throughout the organization.”
During her tenure at Breakthrough T1D, she has helped bring the artificial pancreas project to life, has driven efforts to renew the Special Diabetes Program, and was a key player in Breakthrough T1D’s response to and handling of COVID-19—all with the partnership of our strategic staff and vast network of volunteers, who are the bedrock of our advocacy efforts.
“It’s possible—while challenging—to impact the research and development (R&D) ecosystem to improve options and outcomes for people living with chronic diseases like type 1 diabetes,” says Cynthia. “Defining goals, tapping into strengths, building capacities, and remaining determined in the face of obstacles are critical.”
And for nearly two decades, she has done just that at Breakthrough T1D.
“Leverage—enlisting others to our cause—is critical to our success and core to our organizational DNA, whether it’s engaging friends and families, company R&D heads, government officials, or foundation leaders,” Cynthia says.
The Artificial Pancreas Endeavor
From Left: Breakthrough T1D International Board of Directors member Claudia Graham, Ph.D., M.P.H.; Breakthrough T1D Chief Mission Strategy Officer Cynthia Rice; and Senator Susan Collins (R-ME). Left-click on image to slightly enlarge.
Cynthia came to Breakthrough T1D in September 2005. Real-time continuous glucose monitors (CGMs) were in the early stages of development, with one approved just months prior.
Aaron Kowalski, Ph.D., who had come to Breakthrough T1D a year before and is now the CEO, and Jeffrey Brewer, a member of Breakthrough T1D’s International Board of Directors at the time, had just spent six months interviewing academic scientists, corporate executives, and other like-minded players to figure out whether Breakthrough T1D wanted to take on the development of an artificial pancreas. There were many barriers, and companies were very wary of getting involved.
In the interviews, it became clear that despite the hesitation among companies, there was significant potential benefit for the T1D community in pursuing artificial pancreas technologies. The leadership—needed to foster a therapy roadmap, research funding, regulatory pathway, and health care access—just wasn’t there.
Breakthrough T1D changed that. We made it a priority, bringing not only our research funding, but also our powerful advocacy forces, to speed the development of these devices.
“The goal of multiple artificial pancreas systems, with ongoing innovation, drove our strategy,” says Cynthia, “and we took actions early on with that goal in mind, utilizing our strengths, building new capacities and relationships, and battling doggedly to overcome obstacles.”
Overcoming the Obstacles
Among the first obstacles was that the benefits of continuous glucose monitoring in the management of T1D had only been shown in small studies. In 2008, a Breakthrough T1D multi-site randomized control clinical trial showed that people with T1D who used the devices experienced significant improvement in blood-sugar control. This was instrumental to CGM coverage and laying the groundwork for the artificial pancreas system to come to fruition and be covered by the healthcare system.
Another obstacle was linking together the two main components of a closed-loop artificial pancreas system—the glucose sensor and an insulin pump. Breakthrough T1D established the Artificial Pancreas Consortium, which connected researchers from several different laboratories to develop the computer algorithms so that the machines could “talk” to each other and then be commercialized, as necessary.
A third obstacle—perhaps the most challenging of them all—required engaging government, regulatory, and health care groups.
Breakthrough T1D worked with researchers, insurance companies, the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), Medicare, and Congress on regulatory and coverage issues. When the first artificial pancreas system came on the market in 2016, the T1D community was more than ready for the life-changing T1D management it offered.
“Seeing the artificial pancreas go from concept to reality, which is helping so many people keep their blood-sugar management in control, is what makes Breakthrough T1D and all of the advocacy volunteers—who sent an email, made a call, signed an action alert, or met with their Member of Congress—very proud of this historic achievement and the impact that these will have on the individual lives of those with type 1 diabetes,” Cynthia adds.
The Special Diabetes Program (SDP)
Cynthia Rice (far right, fifth row from the back), Breakthrough T1D volunteers, and Delegates at Children’s Congress 2013 with then-Vice President of the United States Joseph R. Biden (center). Left-click on image to slightly enlarge.
In 1997, with the bipartisan leadership of White House Chief of Staff Erskine Bowles and Speaker Newt Gingrich, Congress created the Special Diabetes Program (SDP), which annually allocates $150 million for T1D research at the NIH. Breakthrough T1D is the chief advocate of the SDP.
The SDP has been instrumental to some of the greatest advancements in the history of T1D—including research that led to artificial pancreas systems and the recent FDA approval of the first-ever drug that can delay onset of T1D, Tzield™ (teplizumab-mzwv).
Since its inception, the SDP has invested $3.4 billion into T1D research. The program’s success and continued renewal is the result in part of hundreds of Breakthrough T1D advocates meeting with their Members of Congress each year to discuss the importance of the SDP.
“Sustaining bipartisan support to renew again and again in challenging times in Washington is thanks to the amazing volunteer-staff partnership in advocacy,” says Cynthia. “This is now paying enormous dividends, not only in the artificial pancreas systems, but in cures therapies, including disease-modifying and cell therapy treatments.”
Breakthrough T1D’s Unique Strengths
“Breakthrough T1D has two strengths that are rare,” says Cynthia. “The first is scientific expertise, convening the best and brightest across fields and generating ideas to solve the biggest problems. The second is community passion, to influence R&D priorities, regulatory pathways, and health care access and enlist government leaders to take action for our cause.”
She adds: “Breakthrough T1D has harnessed these strengths and organized the community, leading to our higher-level power: Influence.”
“It’s not only possible but realizable for a small band of determined people, starting with our founding moms, to tackle and overcome big obstacles,” says Cynthia. “As long as we organize ourselves well, deploy smart strategies, and develop an advocacy message that people can get around, Breakthrough T1D will continue to have the impact that has historically been the pillar of our advocacy work.”
“More broadly, strong patient advocacy strengthens our health system and our society and helps align incentives in research, development, and health policy to benefit the people affected by the disease,” says Cynthia. “All of us as leaders should be thinking about what else we can do to help strong, independent patient communities come together and thrive as advocates, which I hope to do when I return to the health sector in 2024 after a sabbatical.”
A Legacy of Women Leaders
Breakthrough T1D was founded by women, has mostly women staff and volunteers, and counts numerous successful and influential women among its current and past leaders and supporters.
Women who, like Cynthia Rice, share Breakthrough T1D’s vision for a world without T1D and who will stop at nothing to turn that vision into reality.
“From the majority staff and volunteer base, to our women founders, to our international chair Mary Tyler Moore, to our advocates, fundraisers, and scientists,” says Cynthia, “Breakthrough T1D, as an organization, shows the power women can have to impact their world.”
Members of Breakthrough T1D’s Grassroots Leadership Team (GLT) along with members of Breakthrough T1D’s Advocacy Team, including Cynthia Rice (ninth person in from the right) at Breakthrough T1D Government Day 2023. Left-click on image to slightly enlarge.
Cynthia Rice at Government Day 2023. Left-click on image to slightly enlarge.
