Partners in clinical trials

Clinical trials are key to bringing new treatments, therapies, and devices for type 1 diabetes (T1D) from the lab to the clinic. Pharmaceutical and biotech companies, which conduct research and help develop and manufacture new therapies, are a critical player in accelerating this process. Companies often partner with clinical researchers at medical centers and hospitals to test their new therapies through clinical trials. These collaborative partnerships are essential for new drugs to move through the pipeline and get to people with T1D.

Spotlight on the CATT1 clinical trial

The CATT1 clinical trial is investigating whether cadisegliatin (TTP399), a glucokinase activator, can reduce hypoglycemic events (low blood sugars) in people with T1D when used alongside insulin therapy. Read on to learn more about the people making the CATT1 clinical trial happen, the science behind cadisegliatin, and how you can get involved.

Breakthrough T1D x vTv Therapeutics

Breakthrough T1D has a long-standing relationship with vTv Therapeutics. After partnering with Breakthrough T1D in 2017, vTv pivoted from type 2 diabetes to T1D. With Breakthrough T1D’s support, vTv launched a phase 2 clinical trial (SimpliciT1) investigating cadisegliatin as an adjunctive therapy for T1D, showing that it improved blood glucose control. Eager to keep the momentum going, the T1D Fund has supported vTv from early 2024 onwards, most recently participating in the company’s latest round of financing to continue to support the ongoing phase 3 trial for cadisegliatin in T1D.

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“Breakthrough T1D has long been a supporter of adjunctive therapies, meaning medicines that can be taken alongside insulin to improve glucose control and other outcomes. Previous clinical trials have demonstrated the potential for cadisegliatin to reduce hypoglycemia and improve HbA1C in people with T1D, and we are excited to support the phase 3 program to advance this therapy toward the clinic where it can be used to address major unmet clinical needs in our community.”

Jonathan Rosen, Ph.D., Director of Research at Breakthrough T1D

Meet the team at UNC

Within the UNC Medical Center, the EnDO CRU is a hub for endocrinologists, clinical researchers, and other experts who work together to lead clinical studies at cutting edge facilities that help bring new transformative therapies to the people who need them most. Within the EnDO CRU, Dr. Klara Klein and Alex Kass are taking the lead on T1D clinical trials—a passion they both share for different reasons.

T1D has been on Dr. Klein’s mind since she was a little girl. “I grew up hearing about diabetes—my mom is an endocrinologist, and it was a frequent topic at the dinner table,” she said. After following in her mother’s footsteps and becoming an endocrinologist herself, Dr. Klein is shocked that insulin—which was discovered over 100 years ago—is still the gold standard for T1D management. In this sense, not much has changed since she was sitting at the dinner table with her parents.

This sentiment inspires her work. “I’ve always been struck by the daily challenges people with T1D face. Even with incredible advances in technology, managing T1D is a constant effort—every meal, every workout, every illness,” she explained. Her true passion is bringing new therapies to fruition that can ease the daily burden of living with T1D until everyone has access to cures. “Being part of research that could improve the lives of people living with diabetes in meaningful ways is both exciting and deeply rewarding.”

Dr. Klein is supported by a passionate and experienced team composed of five endocrinologist sub-investigators, a nurse coordinator, and a research assistant. She also works closely with Kass, who leads the operational side of many different trials within the EnDO CRU.

Kass is one of a few other staff on the team who is also living with T1D, giving him an inside perspective and inspiring his career to help people with diabetes live better lives. “Having type 1 diabetes myself has fueled my passion for both patient care and finding better treatment options,” he explained. “Together, our team’s mission is simple: to run high-quality studies that give people with diabetes access to promising therapies and make their day-to-day lives easier. This shared passion in our group inspires me!”

The team is working hard behind-the-scenes to recruit and care for participants of the CATT1 clinical trial, which is just one of the many studies they are running to help people with T1D.

Everything you need to know about the CATT1 clinical trial

The phase 3 CATT1 clinical trial is investigating whether cadisegliatin can reduce moderate to severe low blood sugar (hypoglycemic) events when used alongside insulin therapy over a period of six months. Hypoglycemia is the most common short-term complication of T1D, and we need to do more to help people with T1D manage their blood sugar to reduce dangerous lows. This clinical trial is trying to do just that.

Based on observations from previous clinical studies, cadisegliatin may be able to lower the risk of hypoglycemia. Participants in the phase 2 SimpliciT1 study showed clinically meaningful improvements in blood sugar control in addition to a 40% reduction in hypoglycemic events compared to the placebo. Nearly 600 participants have received cadisegliatin so far—it’s been well-tolerated and hasn’t increased the risk of diabetic ketoacidosis (DKA).

Dr. Klein, Kass, and their team are actively recruiting for the CATT1 trial over the next three or so months.

Some key eligibility criteria are:

• Minimum of five years since T1D diagnosis
• At least one moderate to severe hypoglycemic event (Level 2 or 3) in the last two months prior to screening
• 18 years of age or older
• HbA1c levels < 9.5%
• Use of a continuous glucose monitor (CGM) for at least three months prior to screening (excluding closed-loop systems)

Clinical classification of hypoglycemic events

Participants, investigators, and care providers will all be unaware of whether the participants are receiving cadisegliatin or the placebo, which will both be given orally. Participants can expect a combination of in-person and virtual visits over a 26-week period. During these visits, the clinical research team will check blood sugar levels, perform other lab tests to assess safety, and provide top-tier T1D care.

At UNC, for the entire length of the trial, participants will have access to a dedicated study team including a nurse coordinator, research assistant, and diabetes specialists. The clinical research team will guide participants through every step of the process—answering questions, reviewing results, providing support—so that people with T1D and their families can feel confident that they are in good hands.

The science behind cadisegliatin

We know that cadisegliatin has been shown to reduce the risk of hypoglycemia in people with T1D (SimpliciT1 study). The next question is: how?

The answer to this question lies in the liver. The liver plays a major role in blood glucose control by taking up excess sugar from the blood and storing it until it’s needed again. To facilitate this, an enzyme called glucokinase in liver cells is activated in response to higher levels of insulin (indicating high blood sugar). This allows liver cells to remove glucose from the blood, bringing blood sugars down to a normal range.

Some of the glucose in the liver is also converted into glycogen, a storage form for glucose. This way, the liver can help increase blood sugar levels when needed, such as in between meals, overnight, or during exercise, to avoid low blood sugar. In this way, glucokinase helps reduce both hyperglycemia and hypoglycemia.

In people with T1D, the pancreas produces little to no insulin, and injected insulin doesn’t reach the liver the same way insulin from the pancreas does. So, glucokinase doesn’t get the signal that allows liver cells to respond to high blood sugar—making hyperglycemia and hypoglycemia worse.

This is where a glucokinase activator like cadisegliatin comes in. It keeps glucokinase in an active state, which restores the ability of liver cells to respond to (and reduce) high blood sugar. Then, in response to low blood sugar, the liver can release some of the sugar it has stored as glycogen into the blood stream. This is why cadisegliatin is being studied in people with T1D— it has the potential to improve blood glucose control in the liver and reduce the risk of highs and dangerous lows, with the goal of easing the daily burden of living with the disease.

Make a difference for yourself and others by participating in clinical trials

The clinical research team at UNC encourages trial participation as an opportunity to contribute to the body of research that may improve T1D care not only for yourself, but for the T1D community. Participants receive continued support at every step of the way—and safety is the highest priority.

By choosing to participate in a trial, people with T1D may gain access to research treatments, drugs, or devices that may make daily life with T1D easier, while receiving top quality diabetes care delivered by renowned medical centers. The data generated from these trials—thanks to the courageous and brave T1D community members who choose to participate—will shape the treatment landscape for future generations of people with T1D. Dr. Klein is one of many investigators who finds the dedication of the T1D community inspiring. “…I am consistently amazed and moved by the generosity of our participants who dedicate their time and energy to help move science forward,” she explains.

“The T1D community is incredibly generous with their time and motivated to help advance care—not just for themselves, but for the type 1 diabetes community and future generations of people who will live with type 1 diabetes. It’s really an honor to be able to work with them.”

-Klara Klein, M.D., Ph.D.

For Kass, it’s personal. By having T1D himself, he can form deeper connections with trial participants and their families. This allows him to keep conversations honest, participate in shared problem-solving, and understand the same day-to-day challenges of living with T1D—all a part of why he’s excited to be a member of the team providing top-tier diabetes care.

“Some of my favorite moments are when a participant or parent says, ‘You get it,’ and we can talk not just about the study, but about what it means to live well with diabetes. Whether it’s troubleshooting a CGM issue, celebrating a small win in blood sugar control, or simply being a dependable point of contact, I value the trust our participants place in us. That trust is what keeps me passionate about this work.”

-Alex Kass, MSN, MBA, RN, CDCES

Without clinical trials, progress wouldn’t be possible. All new therapies, devices, and treatments need to be tested to get from labs and into clinics as quickly and safely as possible. Thank you to every trial participant—in the past, present, and future—for helping us get closer to a world without T1D.

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!

Contact your U.S. Representative

Contact Your U.S. Senator

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

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.

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.

Learn more about CGMs.

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.

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.

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.

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.

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.

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

Menstrual cycles and type 1 diabetes (T1D) have a lot in common: they can be unpredictable, inconsistent from person to person, and physically challenging. For Women’s Health Month, Breakthrough T1D is taking a closer look at how periods and menopause may influence blood sugar.

What happens during the menstrual cycle?

Most girls get their first period around age 12. Then, each month, the ovary releases an egg; if it doesn’t get fertilized, it’s reabsorbed, and the lining of the uterus is shed as a period. This cycle continues unless the egg is fertilized, after which it implants into the uterine lining (and periods stop). At the end of a woman’s reproductive window between ages 45 and 55, known as menopause, periods stop permanently, and pregnancy is no longer possible.

These complex processes are driven by a conversation between a woman’s brain, ovaries, and uterus, which is controlled by different hormones released at different times. These hormones—such as progesterone and estrogen—may significantly impact blood sugar.

Life with T1D and periods

Women with T1D are more likely to experience longer and irregular periods. More than one-third of teenage girls with T1D—especially those diagnosed before their first period—may have abnormal menstrual cycles. Because 50-60% of people are diagnosed before the age of 15, many women and girls will experience this.

The hormonal culprits responsible for these irregularities affect blood sugar differently depending on the menstrual cycle stage. Progesterone, which is elevated leading to the next period, may increase insulin resistance and the risk of hyperglycemia, especially compared to after the period ends.

The role of estrogen is less clear: it may increase insulin sensitivity—especially when levels are rising post-period—or have no effect at all.

What about menopause?

On average, women diagnosed with T1D before their first period may have a three-year reduction in reproductive lifespan compared to women without T1D—meaning earlier menopause.

As if the barrage of symptoms—including mood swings, brain fog, and sleep issues—weren’t enough, women with T1D might encounter unpredictable blood sugar because of decreasing estrogen and progesterone. Even more, menopause and hypoglycemia can have overlapping symptoms, so special attention is needed to prevent dangerous lows.

Putting it all together

While further scientific studies are required to better understand how hormonal changes affect T1D, there are things you can do to manage your blood sugar more easily.

First, work together with your healthcare team to track blood sugar levels during different menstrual cycle phases or menopause to identify patterns and know what to expect. Women with T1D who take hormonal birth control may have different considerations.

Next, the usual: exercise, eat healthy, and get good sleep. Carefully consider your diet right before your period; while you may crave sugar and carbs, you may also be more susceptible to hyperglycemia, so proceed with caution.

Finally, be kind to yourself. Life with T1D can be hard. Periods and menopause can be hard. Just remember—you’re not alone!

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.