They’re all over the news: Ozempic ®. Trulicity ®. Jardiance ®. Mounjaro ™. And more.

These drugs are all approved for glucose control in type 2 diabetes (T2D). Some of them also have additional indications reflecting their demonstrated benefits for cardiovascular disease, kidney health, and obesity.

None of these drugs are currently approved for people with type 1 diabetes (T1D). However, a recent consensus report addressed the growing interest in GLP-1 receptor agonists as an adjunctive therapy for T1D and their “potential to improve glycemic and metabolic outcomes without increasing the risk of severe hypoglycemia or diabetic ketoacidosis.”

Let’s examine GLP-1 therapies and SGLT inhibitors and consider how drugs like Ozempic may one day help people with type 1 diabetes.

GLP-1 therapies

GLP-1 (glucagon-like peptide-1) receptor agonists work in multiple ways to control blood glucose and obesity. They block the release of glucagon, stimulate insulin production, slow the rate at which your stomach empties, and increase the sensation of feeling full. They are usually injected, but oral versions are available.

In people with T2D, this class of drugs lowers blood sugar levels and, for most people, causes weight loss. GLP-1 therapies have also been shown to reduce the risk of long-term cardiovascular complications often experienced by people with T2D, such as heart attack and stroke.

GLP-1 drugs include Ozempic/Rybelsus/Wegovy (semaglutide), Trulicity (dulaglutide), Victoza (liraglutide), and Mounjaro (tirzepatide), among others.

When GLP-1 treatments hit the market in the early 2000s, Breakthrough T1D and others funded several clinical trials to test whether GLP-1 receptor agonists, in addition to insulin, improved outcomes for people with type 1 diabetes. While some of these studies showed that the addition of GLP-1 therapies to insulin led to improvements in HbA1c, total insulin dose, and weight, the benefits were relatively modest and accompanied by some side effects like hypoglycemia. As a result, these studies did not lead to GLP-1 receptor agonists being highly adopted for use by people with T1D.

However, these trials were done with older GLP-1 drugs. We are investigating whether the newest, most advanced GLP-1 therapies (like Ozempic) will improve the health of people living with type 1 diabetes. (See below!)

SGLT inhibitors

SGLT (sodium-glucose co-transporter) inhibitors are oral medications for people with T2D that lower blood sugar by preventing the kidneys from reabsorbing glucose, leading to the excretion of sugar through the urine.

In addition to improving blood sugar for people with and without T2D, these drugs also provide benefits such as weight loss, blood pressure reduction, and transformative benefits to the heart and kidneys.

SGLT drugs include Jardiance (empagliflozin), Farxiga (dapagliflozin), and Invokana (canagliflozin), among others. Despite demonstrating improved glucose control for people with type 1 diabetes, SGLTs have not been approved for people with T1D in the U.S. Increased risk of diabetic ketoacidosis (DKA) in this population limits the use of these therapies. A key Breakthrough T1D priority is to find ways to mitigate this risk so people with T1D can also take advantage of the SGLT cardiovascular and renal benefits.

Breakthrough T1D-funded research in GLP-1 and SGLT therapies

Breakthrough T1D has a long history with GLP-1 medications like Ozempic. In the 1980s, Breakthrough T1D-funded researcher Pauline Kay Lund, Ph.D., was the first to clone the hormone glucagon and discover two new hormones, one of which was GLP-1.

Today, there is real-world evidence of GLP-1 receptor agonists improving the lives of people with type 1 diabetes.

Evidence demonstrates that semaglutide (Ozempic) or tirzepatide (Mounjaro) have the potential to lower A1c, increase time-in-range, and reduce the amount of daily insulin needed in people with T1D. More research is needed in this area. That’s where Breakthrough T1D comes in!

Breakthrough T1D-funded research on GLP-1 and SGLT therapies is investigating the benefits of these drugs for people with T1D, including reducing the risk of common complications of type 1 diabetes like cardiovascular disease and kidney disease.

Snapshot of active clinical trials in GLP-1 and SGLT therapies

Here are a few examples of Breakthrough T1D-funded clinical trials in GLP-1 and SGLT therapies that are currently underway:

Our commitment to improving lives

Breakthrough T1D strives to improve health outcomes in people living with type 1 diabetes. Insulin therapy alone is often not enough for people with T1D to achieve glucose and metabolic control. The use of adjunctive drugs that complement insulin therapy can help. Since the FDA has already approved these medications for treating other conditions, positive results from these clinical trials could speed up the adaptation of these therapies for people living with T1D.

Learn more about clinical trials and how they are advancing breakthroughs for the T1D community.

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: 

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! 

Update – November 22, 2024

This morning, Lexicon Pharmaceuticals, Inc. (Lexicon) announced they received a “deficiencies preclude discussion” letter from the FDA regarding this drug application. The FDA is not approving sotagliflozin for use in glucose control in people with T1D and CKD and there will be no further discussion in regards to this application. 

As a result, Lexicon announced that they will stop pursuing sotagliflozin for use in glucose control in people with T1D and CKD.

Breakthrough T1D is extremely disappointed with this decision. Our funded research exploring the use of sotagliflozin in people with T1D will continue, and we will continue to push on multiple fronts for therapies, like this one, that can help address the burden and unmet needs of the T1D community. 

Read out full statement.

There is a deep unmet need for therapies in addition to insulin for glucose control in people with T1D. This is especially true for those with additional complications like CKD. Today, a U.S. Food and Drug Administration (FDA) advisory committee recommended against the agency approving Lexicon’s sotagliflozin for blood glucose control in individuals with T1D and CKD. Breakthrough T1D believes this drug has benefits for people with T1D and those benefits outweigh the risks.

The case for more therapies

For over 100 years, insulin therapy has been the main treatment for T1D. Better insulin options and new technologies, like continuous glucose monitors and automated insulin delivery systems, have improved health and quality of life for many people with T1D. There is nothing that people with T1D cannot accomplish. But, by nearly every health-related quality of life metric, people with T1D score lower than individuals without T1D. This includes general health, mental health, vitality, physical functioning, social functioning, and others.

If you look specifically at T1D metrics, a similar picture appears. Only 26% of individuals with T1D achieve an HbA1c level under 7%, the American Diabetes Association’s recommended HbA1c target to reduce the risk of long-term diabetes-related complications like cardiovascular and renal disease and diabetic retinopathy.

Despite the significant advances that Breakthrough T1D has been instrumental in realizing, people with T1D are not doing well enough. We need tools that make it easier to do better.

What is sotagliflozin?

Sotagliflozin is an SGLT (sodium-glucose co-transporter) inhibitor. SGLT inhibitors are oral medications originally developed for people with type 2 diabetes (T2D). They lower blood sugar by preventing the kidneys from reabsorbing glucose, leading to the excretion of sugar through the urine.

In addition to improving blood sugar, this class of drugs provides transformative benefits and have been approved for heart and kidney health in people with T2D and people without diabetes. In addition, they promote weight loss and blood pressure reduction.

Benefits of sotagliflozin for people with Chronic Kidney Disease

It has long been recognized that maintaining tight glucose control is crucial for preventing chronic kidney disease (CKD) in individuals with T1D. Recent data indicate that for those with T1D who already have CKD, there is a significant correlation between high HbA1c levels and an accelerated loss of kidney function. Therefore, effective glucose management is vital for individuals with both T1D and CKD to avert serious health complications.

In addition to improving glucose control, sotagliflozin has shown improvement in CKD outcomes in large trials of people with T2D. It is reasonable to expect these benefits would also be seen in those with T1D who also have CKD. While we do not yet have data on long-term kidney outcomes associated with sotagliflozin in T1D, we are encouraged by data demonstrating that sotagliflozin improves key biomarkers of kidney function in people with T1D.

The risk of diabetic ketoacidosis

There is one key consideration for the safe use of sotagliflozin: the risk of diabetic ketoacidosis (DKA).

Using SGLT inhibitors can increase the risk of DKA in people with T1D, so it’s important to monitor and manage this risk. In 2018, experts came together to address these concerns. Their findings led to an international agreement in 2019 on how to reduce the risk of DKA in people with T1D who are using SGLT inhibitors.

However, DKA is a risk for everyone with T1D, not just those taking SGLT inhibitors. It’s important to be aware of DKA as a regular part of managing T1D.

Breakthrough T1D has long supported research to advance safe, effective use of SGLT inhibitors in T1D

Breakthrough T1D’s Improving Lives program supports the development of SGLT inhibitors for T1D; this includes trials to assess benefits and risks of this drug class in T1D, as well as device-based and other strategies for DKA risk mitigation. SGLT inhibitors are FDA approved for T2D and certain non-diabetic populations such as those with CKD or heart failure, and they are used by some people with T1D off-label. Our work supports studies to build a body of evidence that will allow people with T1D to improve health outcomes through safe and effective use of SGLT inhibitors.

What comes next?

Breakthrough T1D believes the benefits outweigh the risks for people with CKD and T1D and sotagliflozin should be approved. That’s why Sanjoy Dutta, Ph.D., Breakthrough T1D Chief Scientific Officer, delivered public comments in support of the drug’s approval today.

As the formal review process moves forward, Breakthrough T1D will continue to invest in research to develop therapies for kidney disease in T1D that can help people live longer and healthier lives. While the advisory committee’s recommendation plays a critical role, it is not the only consideration in the final decision of approval (or not). The overwhelming majority of people with diabetes and world-renowned healthcare providers who commented were in agreement with Breakthrough T1D that the drug should receive approval.

Read our full comments.

The FDA are required to make a decision by December 20, 2024.

Editor’s note: Written by guest blogger Matthew Tilton, D.O. In addition to being a physician, he is the father of  9-year-old Adalyn (pictured above), who lives with type 1 diabetes (T1D). Read his previous story for Breakthrough T1D.

As summer draws to a close and the back-to-school season begins, many parents are busy preparing their children for a new academic year. For many families, this requires a few more checkboxes on the list. My daughter Adalyn, who has type 1 diabetes (T1D), requires more than the usual school supplies and new clothes. Our back-to-school checklist includes items like insulin, glucose monitors, and an emergency care plan, all essential for her well-being.

As a parent of a child with T1D, the transition to a new school year brings a mix of emotions. There’s the usual excitement and straight-up anxiety. Will the teachers have questions? What will her classmates say? These are the questions that linger in my mind as the school year approaches. It turns out I am more anxious than she is.

The importance of a well-coordinated support system

Adalyn, however, is determined to approach the new school year with confidence. “I am a little nervous, but not much. I know my nurse is there to help me,” she said recently. Her words are a reminder of the importance of having a well-coordinated support system in place. Making sure the school nurse knows Adalyn’s care plan and is prepared to respond to any situation is a critical step in ensuring her safety.

Related content: School nurses have incredible impact

Additionally, we’ve worked closely with her teachers to make sure they’re aware of her condition and know how to take the right steps now to ensure her success later. This includes understanding the signs of high or low blood sugar and knowing when to allow her a break or snack. If you are looking for permission to be “that parent,” here you go. Be that parent. As a physician, occasional coach, and father, I have never once thought, “Oh, I really regret being too prepared for this.” I am sure I may be a headache, but it is this collaboration between parents, healthcare professionals, and educators that forms the foundation of a safe and supportive learning environment.

Creating an environment for thriving

Let’s not forget that continuous glucose monitors and insulin pumps have been life-changing. I’m thankful for the incredible advancements in medical technology that allow Adalyn to lead a relatively normal life. These tools enable her to do things she loves, like playing softball and other sports. But these tools are only part of the equation. The real challenge lies in creating an environment where she can thrive academically and socially, without constant worry. 

This is where awareness and education become crucial. Schools must be equipped with the knowledge to support students with T1D, with the necessary medical supplies, and foster an environment where every child feels safe and understood. I have it on good authority teachers aren’t trained on T1D and all that comes along with it. That is where we—the prepared parents—come in. Teachers, staff, and even fellow students need to understand what T1D is and how they can help. A simple understanding can go a long way in making sure children like Adalyn feel safe and supported.

Setting our schools—and kids—up for success

If there’s one thing I’ve learned, it’s that managing type 1 diabetes is a team effort. It requires not just the dedication of parents and medical professionals, but also the understanding and cooperation of educators and community members.

So, as we prepare for another school year, I want to make a call to action. Let’s set our schools—and our kids—up for success. Let’s ensure that our schools are prepared to support children with T1D and other chronic conditions. This means advocating for better training for school staff, ensuring that schools have the necessary medical supplies, and fostering an environment where every child feels safe and understood.

As we send our children back to school, let’s also commit to sending them into environments where their health needs are met with compassion and competence. Let’s work together to ensure that every child, regardless of their medical condition, has the opportunity to learn and grow in a safe and supportive setting. This is not just about managing a disease; it’s about empowering our children to live their fullest lives. And until there are cures, we parents and caregivers must be the advocates, the educators, and the support system they need.

Together, we can make a difference

Breakthrough T1D offers a school guide to help parents advocate for their children’s needs. They also have resources to help educators understand the unique needs of students with T1D. Consult their T1D Resource Library for the school guide and other helpful life with T1D guides. 

The road ahead is challenging, but we are not alone. Together, we can make a difference. Just like Adalyn confidently steps up to every challenge, we, too, must step up, ensuring that every child with T1D has the chance to thrive, both in school and in life.

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.

1. 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.

vTv Therapeutics (vTv), a biopharmaceutical company developing an adjunctive therapy for type 1 diabetes (T1D), announced a $51 million financing round, including an investment from the Breakthrough T1D T1D Fund, Breakthrough T1D’s venture philanthropy arm.

vTv will use this financing to fund a phase III clinical trial of cadisegliatin (TTP399), an adjunct therapy to insulin for people with T1D. Per vTv, this trial is expected to begin in 2024.

Cadisegliatin is a liver-selective glucokinase (or GK) activator. GK in the liver and other organs acts as a critical regulator of sugar levels in the body. When blood sugar levels rise, activation of GK in the liver stimulates glucose utilization, lowering glucose levels in the blood. Cadisegliatin is administered as a tablet.

After completing several studies in participants with type 2 diabetes, vTv Therapeutics joined forces with Breakthrough T1D in 2017 to also test cadisegliatin in people with T1D. In the phase II clinical trial, called Simplici-T1, cadisegliatin significantly improved HbA1c in people with T1D. Additionally, trial participants who received cadisegliatin showed a reduction in insulin dose, reduced hypoglycemia (low blood sugar), and no increase in diabetic ketoacidosis (DKA).

Breakthrough T1D has funded studies into glucokinase since the early 1980s, including funding for Franz Matschinsky, M.D., who made the seminal discovery of glucokinase as the primary glucose sensor in the pancreas. With funding from Breakthrough T1D, he went on to collaborate with then-unknown scientists who today are leaders in the diabetes space, including Mark A. Magnuson, M.D., who is now the leading investigator on glucokinase activity, and Barbara Corkey, Ph.D., who is known for her pivotal work on obesity and diabetes.

Breakthrough T1D is excited that the Fund’s investment will continue this partnership and help move this promising therapy through the drug development pipeline into a phase III clinical trial.

Editor’s note: Written by guest blogger, Grace Bennett, Social Media Manager at Breakthrough T1D. The opinions expressed by the author are her own and are not necessarily those of  JDRF, its leadership, employees, or supporters.

Life with T1D means you don’t only observe your birthday, holidays, and anniversaries. You also usually in some way mark your “Diaversary” or the day your life with T1D began.

I’ve always felt a bit conflicted about my Diaversary. While I feel like I should do something to recognize a day that completely changed my life, it’s obviously not something I necessarily want to celebrate.

Who in their right mind would celebrate being diagnosed with a condition that adds significantly to one’s mental load (and that’s just the tip of the iceberg!)?

I tend to quietly acknowledge my Diaversary with my family and then move on.  That changed a few weeks ago, when I realized that life with type 1 diabetes (T1D) has taught me a lot of life lessons that I might not have learned otherwise. So, here are the 19 things I’ve learned over the 19+ years I’ve lived with T1D.

• Pretending something isn’t happening is not going to make it go away. This was my approach to T1D management during my teenage years, 0/10 recommend. Also, sorry mom and dad!
• If you overpack extra supplies, you likely won’t need them. You know when you will? The one time you try to “pack light.”
• Most of the time, people who suggest homeopathic “cures” like cinnamon for your T1D mean well, even though they are misguided. Using these moments as an opportunity to educate instead of getting defensive will feel a lot better than jumping down someone’s throat.
• Just because your illness is largely invisible doesn’t mean it’s easy. You’ll hear a lot of “at least it’s T1D and not *insert scarier illness here*” but the truth is, no one “wins” in a contest of who has it worse. Any illness or health condition is difficult in its own way.
• I really do not care if people see my T1D tech. I promise when you look back on photos from your eighth grade dance, the tubing from your insulin pump being visible won’t be one of things you cringe at.
• Pack the number of low treatments you think you’ll need and then double it. You’ll thank me later.
• Don’t get caught up in comparison to other people living with T1D who seem to be doing better than you are.  This is the furthest thing from a “one size fits all” disease.
• Your blood sugar will get low at the MOST inconvenient times.
• Find community, whether it’s in-person or online. JDRF’s CEO, Dr. Aaron Kowalski says frequently that the T1D community is “the best club you never want to be a part of” and he is spot on.
• Don’t beat yourself up if you’re having a bad blood sugar day, especially an inexplicable one.
•  Speaking of, don’t forget that more than just carbohydrates and exercise impact blood sugar. Stress, having a cold or the flu, hormonal changes, and any other number of variables can also throw your HbA1c off kilter.
• Don’t be afraid to advocate for yourself and ask questions at your medical appointments. If something doesn’t feel or seem right to you, mention it!
• Don’t fall into the trap of defining your whole life as “good T1D days” and “bad T1D days.” If you tried your best, even if your blood sugar wasn’t exactly where you wanted it to be, remember your best is enough.
• The field of T1D research IS progressing faster than ever before in the most exciting ways. Working at Breakthrough T1D and getting to see not just the big milestones, but also the small pieces of progress being made is something that’s been an eye opener.
• Your friends and family who don’t live with T1D won’t ever fully understand how it feels, but that doesn’t mean they don’t want to. Try your best to keep that in mind.
• It’s in no way, shape, or form your fault that your body doesn’t do something it’s supposed to.
• There really is no such thing as a stupid question when it comes to T1D—if you aren’t sure about something, ask!
• T1D burnout is real and can look different for everyone. If you find yourself struggling, I promise that asking for help will make you feel a massive wave of relief.
• Feel your feelings; resentment, anger, frustration, joy, sadness, etc., are all part of life with T1D. There is no wrong way to feel about life with a chronic illness.

As Breakthrough T1D’s Social Media Manager, I can confidently say that the T1D community has a tremendous amount of wisdom about life with T1D to share beyond the points I’ve listed here. Don’t forget to go check out the comments on our Social Media channels for more advice from this incredible group of folks!

Semaglutide, brand names Ozempic®, Rybelsus®, and Wegovy®, is all over the news. It is FDA-approved to help people with type 2 diabetes (T2D) manage their blood glucose levels. It also decreases the risk of cardiovascular events and helps with weight loss. According to study results published in the New England Journal of Medicine [subscription required] by investigators at the State University of New York at Buffalo, it may also help newly diagnosed individuals with type 1 diabetes (T1D) make more insulin.

What Is Semaglutide?

Semaglutide is a glucagon-like peptide, or GLP-1. It helps people with T2D in various ways, including by stimulating insulin production. These drugs have been on the market since the early 2000s.

Thanks to decades of Breakthrough T1D-supported research, we know that people diagnosed with type 1 diabetes (T1D) still have functioning beta cells. They no longer make the amount of insulin needed by the body to function, but they do exist.

Preserving those beta cells, keeping them healthy and alive and, eventually, increasing their number and function through disease-modifying therapies is one of Breakthrough T1D’s key priority areas.

“The preservation of the remaining functional beta cell population is a critical component of developing disease-modifying therapies for patients with new-onset type 1 diabetes,” said Breakthrough T1D Director of Research, Joshua Vieth, Ph.D.

Study Results

The researchers in this study, who currently receive Breakthrough T1D funding to investigate the use of semaglutide later in disease to assist with glycemic control, administered the drug to 10 individuals. These individuals were between the ages of 21 and 39 in stage 3, or new-onset T1D. They began treatment with semaglutide within three months of diagnosis with the goal of preserving beta cell function. Nine individuals tested positive for GAD, an antibody which can indicate the presence of autoimmunity; one tested positive for IA-2, another autoantibody. Over the course of several months, all 1o individuals no longer had to administer insulin at mealtimes and six of the participants no longer needed basal insulin after six months. Additionally, participants saw an increase in c-peptide, which shows that their bodies were making more insulin after being on the therapy.

What Comes Next

These results are exciting, but much more work is needed.

“Overall, these are promising early results, suggesting it may be possible to extend the honeymoon period in early type 1 diabetes, and making it clear that further study is necessary into the mechanisms involved,” said Vieth.

According to Vieth, this study raises additional questions for researchers. In particular, what effect does using semaglutide to increase insulin production by the remaining beta cells have on these cells? It’s possible that this adds further stress on these cells. We need to determine what the effect of this stress will be beyond the length of this study. Will the beta cells continue to produce insulin or will insulin production decline? All of this must be investigated in a larger, follow-up study with a control group.

GLP-1’s Are a Priority for Breakthrough T1D

Breakthrough T1D has been a central player in the discovery and development of GLP-1’s for decades. In fact, a Breakthrough T1D-funded researcher named Pauline Kay Lund, Ph.D., was the first to discover GLP-1 and GLP-2. Since then, Breakthrough T1D has funded many studies to better understand this hormone, how it functions, and how it can be used to help people with T1D. In particular, Breakthrough T1D believes semaglutide has tremendous promise to improve glucose control and mitigate heart and kidney complications for individuals in stage 4, or established T1D.

That work continues today. There are several Breakthrough T1D-funded clinical trials to see how people with established T1D can benefit. This includes research led by Dr. Viral Shah at the Barbara Davis Center at the University of Colorado—and in collaboration with three other leading diabetes centers (Henry Ford Hospital, Iowa Diabetes, and the Oregon Health & Science University)—which is investigating ways semaglutide may benefit people with T1D and obesity who are using artificial pancreas (AP) systems

These drugs are also being explored by the Breakthrough T1D T1D Fund. T1D Fund portfolio company i2O Therapeutics is developing several products leveraging GLP-1s, initially for T2D, including a refillable, implantable GLP-1 device that delivers 6 month’s worth of the hormone, an oral form of long acting GLP-1, as well as a combined oral GLP-1 with Amylin (another important gut hormone).

Additionally, Code Bio, a T1D Fund portfolio company, has explored GLP-1 to target beta cells for targeted drug delivery.  

Read more about the potential benefit of these drugs in people with T1D here.

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 

Celebrating the Best of 2021 

What We Can Be Proud Of in 2020 

Top 10 T1D Breakthroughs of 2019 

Today, Dexcom announced that the U.S. Food and Drug Administration (FDA) cleared the Dexcom G7® Continuous Glucose Monitor (CGM) system for ages 2+. People with diabetes will now have a smaller and more accurate CGM to help manage their blood-sugar levels.

“Breakthrough T1D is thrilled that the Dexcom G7 was cleared by the FDA,” says Breakthrough T1D Director of Research, Jonathan Rosen, Ph.D. “Rigorous research has shown many times over that CGM devices improve glucose control and other health outcomes. The Dexcom G7 features many notable improvements that are aligned with Breakthrough T1D’s goal of people with type 1 diabetes having access to effective, convenient therapies.”

G7 Enhancements

Smaller Profile, Easier Insertion

The G7 is 60% smaller than the G6 and has a simpler, one-step insertion process. The G6 has a transmitter that is reused for several weeks and inserted into each new sensor; the G7 is one disposable unit.

Shorter Warmup Time

A warmup period is required after the insertion of the sensor. During that time, the user does not have access to their blood-sugar levels. The warmup for the G6 is 2 hours, but only 30 minutes for the G7. That’s an extra 90 minutes per 10-day use sensor that the user has access to data with which to make decisions.

More Accurate

The G7 is more accurate than the G6. Dexcom published data from their pivotal trial demonstrating the safety and efficacy of the device. Of note is the G7’s Mean Absolute Relative Difference (MARD), which is a key metric used to evaluate CGM accuracy. MARD calculates the average difference between the glucose reading on the CGM with a blood-glucose measurement measured via a blood sample. The MARD for the G7 is 8.2% for sensors placed on the upper arm. That means the reading from the Dexcom is, on average, 8.2% different than the reading on the glucometer. This is an improvement over the G6’s 9% MARD for sensors on the abdomen (the G6 is not approved for use on the upper arm).

Breakthrough T1D has played a pivotal role in novel CGM development, as well as access and adoption, including supporting a clinical trial that conclusively demonstrated that CGM use improved health outcomes for people with diabetes. Dexcom G7 is one of several commercially available CGM systems now, which gives people with T1D the freedom to choose the tools and systems that are right for them.

Breakthrough T1D will continue to monitor the field and push for meaningful technological advancements, and we won’t ever stop fighting for affordability, choice, and coverage on our path to a world without T1D.

Breakthrough T1D and Dexcom have a history of mutual support. Breakthrough T1D awarded a grant to Dexcom in 2015 and Dexcom provides Breakthrough T1D-funded studies with supplies. Breakthrough T1D did not fund research into the development of the G7.

Per Dexcom, they are working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible.

Dexcom anticipates the G7 will be available in early 2023.