People living with type 1 diabetes (T1D) need to check their blood sugar levels on a regular basis. Without regular checks during both the day and night, blood sugars may get too high (hyperglycemia) or too low (hypoglycemia). While some people opt to monitor their blood sugar (glucose) levels through finger pricks, others choose to use technology like continuous glucose monitors (CGMs).

CGMs are wearable devices that measure glucose levels every one to five minutes and help people with T1D determine if they need to take immediate action to manage their diabetes. CGMs can also help to identify long-term patterns in glucose levels that can be used to adjust diabetes management plans. Through connected apps, CGMs can often generate a full picture of a person’s glucose trends, from current and average levels to increasingly important metrics like time in range. Read on to learn about the power of time in range—what it is, why it matters, and future applications.

What is Time in Range?

Time in range is used by people with T1D and their care teams to see how often glucose levels are within the recommended range. Current standards of care recommend that most people with T1D aim for the following targets:

While each person has different glucose targets, most people living with T1D should aim to have their glucose levels in the recommended range, which is considered safe and healthy for most. People with T1D should work closely with their healthcare teams to review CGM data and create personalized high and low alerts, which often change based on time since T1D diagnosis, age, complications, hypoglycemia unawareness, pregnancy, and more.

CGMs also produce 24-hour graphs (as shown in the figure below), which show whether glucose levels are in, above, or below range at different time points throughout the day. Since glucose levels can change day to day, healthcare teams generally review patterns over a 14-day period. Percentage of time spent in, above, or below range coupled with the 24-hour graph are especially helpful in identifying glucose patterns according to time of day.

Why Time in Range is Important?

The most important feature of time in range (and CGM data) is that it can provide people living with T1D with an extensive overview of how and when their glucose levels change throughout the day. Blood sugars can change based on exercise, meals, stress, hormones, and more—and time in range can help people understand how lifestyle factors come into play for their personal blood sugar management.

“Time in range helps people with T1D better understand glucose patterns that are not captured by HbA1c,” explains Brynn E. Marks, M.D., MSHPEd, Senior Director of Medical Affairs at Breakthrough T1D. “Additionally, CGM can help people to review their glucose patterns in between visits with their diabetes team and allow for more frequent adjustments to their insulin doses.  Reviewing and acting on time in range data and glucose patterns identified by CGM can empower people to manage their T1D and to avoid the roller coasters of managing high and low blood glucose that negatively impact quality of life.”

Spending more time in range is becoming increasingly associated with a lower risk of developing complications, although further research is needed to better understand this connection. Time in range is also often used as an outcome measurement in clinical trials to help researchers understand if a new therapy or treatment is improving blood sugar management. So, the benefits of time in range go beyond personal blood sugar trends, and as we continue to improve our understanding of this metric, its applicability in research and beyond will continue to broaden.

What’s Next for Time in Range

Time in Tight Range

Time in tight range, which is also sometimes referred to as time in normal glycemia, is defined as the percentage of time spent with glucose levels between 70 to 140 mg/dL. People without diabetes have a time in tight range of about 96%. As diabetes therapies and technologies continue to advance, we are just beginning to understand the potential clinical benefits of  aiming for a narrower glucose range in people with T1D. Researchers suspect that fluctuations outside in time in tight range may be a better predictor of complications risk. Yet, before we integrate time in tight range into clinical decisions, more research is needed to uncover the benefits of this metric and advance therapies and technologies that will allow people to achieve this narrower target without creating additional undo burden. 

Automated Insulin Delivery Systems in Clinical Trials

Diabetes technology has advanced tremendously in the past few decades, largely driven by Breakthrough T1D. Right now, we have automated insulin delivery (AID) systems that can automatically increase or decrease insulin delivery based on CGM readings. These AID systems help to improve time in range and time in tight range while decreasing high and low blood sugar levels, but meal announcements are still required. Fully closed loop systems in the pipeline will not require mealtime announcements. This next-generation technology has the potential to help people achieve time in range targets while using less effort to manage T1D. Breakthrough T1D is funding studies to drive innovation in fully closed-loop systems and bring newer generations to the T1D community quickly and safely.

Non-Insulin Therapies

Therapies used alongside insulin and AID systems have the potential to improve both blood sugar levels and metabolic health. Breakthrough T1D is funding studies investigating treatments that can address insulin resistance, weight management, hypoglycemia, and long-term complications. The goal is to customize treatment approaches and ensure that the T1D community can choose from multiple drugs that may best manage blood sugars and overall health.

While exciting advancements in treatments and devices are coming down the pike, many people living with T1D are still unable to reach time in range goals with the tools currently available. Access to improved technologies and non-insulin therapies that can help people with T1D achieve optimal glucose targets will make it possible to use time in tight range goals as the standard of care. Because glucose targets are personalized, time in tight range may not be the right metric for everyone, and more research is needed to see which populations may benefit the most. In the meantime, Breakthrough T1D is working tirelessly to improve the lives of the T1D community, help people achieve the best blood sugar management possible with the options available now, and accelerate the next breakthroughs through the pipeline.

“In the future, I think we will see greater use of time in range in T1D management by people with T1D and care providers as adoption of CGM continues to increase. A growing body of evidence suggests that greater time in range, like low HbA1c, is associated with a lower risk of developing long-term complications. These data might not only support CGM use and attention to time in range in clinical decision-making, but may also impact the way new therapies are evaluated. Today, time in range is widely accepted as a means to evaluate AID systems, but we are not there yet when it comes to evaluating new drugs. Finally, there is a lot of ongoing research to understand time in tight range and how this will help us with clinical guidance and therapy development in the future.”

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

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 glucose control in 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 (low blood sugar). 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. The SGLT inhibitors empagliflozin and dapagliflozin are approved to treat chronic kidney disease and heart failure, regardless of diabetes status.

Yet, increased risk of diabetic ketoacidosis (DKA) in people with T1D limits the use of these therapies to improve blood sugar management or reduce the risk of complications. A key Breakthrough T1D priority is to find ways to mitigate this risk so people with T1D can also take advantage of the benefits of SGLT inhibitors.

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!

Most recently, the Breakthrough T1D-funded ADJUST-T1D clinical trial showed that, in people with T1D and obesity or overweight using an automated insulin delivery system, Ozempic can help manage both weight and blood sugar.

Additional 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.

Reporting live from New Orleans, LA! Breakthrough T1D is on site at ADA 2026 with leading scientists, clinicians, healthcare professionals, industry partners, and more to hear about exciting updates in type 1 diabetes (T1D) research—including work supported by Breakthrough T1D.

Read on for everything you need to know from the first two days ADA 2026, including key takeaways from panels and sessions featuring Breakthrough T1D staff and noteworthy highlights from Breakthrough T1D-funded researchers—both past and present—whose work was front-and-center.

Cell Therapies: Breakthrough T1D Staff at the Forefront

Sanjoy Dutta. Ph.D., Chief Scientific Officer, participated in a panel discussion about advancing manufactured islet cell therapies for widespread clinical use. A major theme was that eligibility requirements for clinical trials are too narrow—which means that less people have the chance to benefit and trials don’t progress as quickly. Patient-reported outcomes will be important to demonstrate to regulators that many people with T1D can and want to benefit from islet cell replacement therapy, and we need established, systemic methods in place to take the T1D community’s opinions into account.

The panelists also discussed the current challenges surrounding immunosuppression, which is one of the barriers to clinical trial participation, and ongoing efforts to develop novel cell protection strategies. Immunotherapies in development for early-stage T1D may be applicable in islet cell transplant settings, including approaches that retrain the immune system to ignore beta cells—an area that Breakthrough T1D is invested in.

To accelerate progress in manufactured islet cell therapies, the panelists agreed that the top priorities are:

• More companies exploring novel approaches
• Expanding eligibility criteria for trials—and incoporating the perspectives of the T1D community into regulatory decisions—so we can build more evidence around the safety and efficacy of manufactured islet cell therapies
• Additional frameworks to help guide the field, like our cell therapies roadmap and upcoming publications from Breakthrough T1D staff around manufacturing and preclinical considerations
• Optimizing manufacturing processes to reduce costs and ensure access for people who want these therapies
• Optimizing cell therapy products by reducing or eliminating the need for immunosuppression and finding the best transplant site for survival

Brynn Marks, M.D., Senior Director of Medical Affairs, chaired a session about the promise and perspective of islet cell replacement therapies for kids with T1D. Notably, Melena Bellin, M.D. (University of Minnesota) spoke about insights from children with pancreatitis who require full pancreas removal and receive transplants of their own healthy islet cells into their livers. In comparison to adults, children who receive this type of dual transplant have higher rates of islet survival and function and are more likely to stop needing external insulin. Laura Jacobsen, M.D. (University of Florida) spoke about practical clinical expectations for cell therapies and DMTs based on the data we have in adults and what this might mean for kids. Finally, Jane Speight, Ph.D. (The Australian Center of Behavioral Research in Diabetes) closed out with a talk about psychosocial considerations for pediatric islet cell transplantation.

Disease-Modifying Therapies

The Potential for a New and Improved C-Peptide

• Presenter: Samuel Sangqu Wu, Ph.D. (University of South Florida)
• C-peptide has the potential to be a validated endpoint for DMT clinical trials, and researchers like Dr. Wu are looking into new ways to help make this possible.
• Time to minimal residual C-peptide (TMRCP) is defined by how much longer people will have measurable C-peptide—meaning how long they will continue to make insulin.
• Dr. Wu applied this metric to six TrialNet studies and found that extrapolating TMRCP identified the same treatments as effective as each original analysis.
• TMRCP may be another metric to define the clinical meaningfulness of C-peptide, meaning it could be an alternative endpoint to consider for future DMT trials.
• Breakthrough T1D supported these efforts.

TEPLI-REAL: Evaluating Real-World Outcomes of People Treated with Tzield

• Presenter: Stephen Gitelman, M.D. (University of California, San Francisco)
• The purpose of this study was to understand populations who pursue treatment with Tzield and post-treatment outcomes through review of electronic health records.
• Diagnosis of T1D is heterogeneous, with people having either autoantibodies or dysglycemia (abnormal blood sugar) detected first, or others having both detected at the same time.
• These diagnostic pathways influence Tzield initiation. Those who had dysglycemia and autoantibodies detected at the same time had the shortest median time to start treatment.
• Most people who initiated Tzield were adolescents, and 94% of people who started treatment completed the full 14-day course.
• This study offers important considerations for healthcare professionals (HCPs) regarding how T1D diagnosis influences Tzield treatment in routine practice.

Decoding Immune Mechanisms and Engineering the Immune System in T1D

• Todd Brusko, Ph.D. (University of Florida) presented on spatial locations of different immune cells that contribute to the autoimmune process in T1D pancreases—and the underlying mechanisms that influence this.
• Kyle Gaulton, Ph.D. (University of California, San Diego) uncovered single-cell changes in pancreatic cells from T1D pancreases using advanced genomic methods.
• Mohammad Haj Dezfulian, Ph.D. (University of Pennsylvania) mapped T1D antigens contributing to autoimmunity by taking a closer look at T cells, which play a role in destroying insulin-producing beta cells.
• Remi Creusot, Ph.D. (Columbia University) presented on a different approach to retraining the immune system to ignore beta cells, starting with precursors to immune cells.
• Together, these studies are deepening our understanding of how and where the immune system attacks insulin-producing beta cells in T1D—and uncovering new ways to retrain it.

Early Detection

Clinical Implementation of Pediatric T1D Screening and Monitoring

• Presenter: Sarah Lydia Holly, BSN, RN (Children’s National Hospital)
• Six pediatric endocrinology centers worked together to increase T1D screening and monitoring rates in kids through quality improvement and operational strategies.
• Between June 2024 to February 2026, the teams implemented patient and HCP education strategies, integration of screening and monitoring in clinical workflows, defined pathways for follow-up, and multidisciplinary coordination.
• The teams exceeded their goal and screened 1700+ people. No cases of diabetic ketoacidosis (DKA) reported, 85% engaged in long-term monitoring, and 73% were offered Tzield.
• This study demonstrates the feasibility of screening and monitoring in routine pediatric care, and this can facilitate early intervention and DKA prevention.

Improving Lives

Discontinuation of Roche’s Dual GLP-1/GIP Receptor Agonist for T1D

• Presenter: Jeremy Pettus, M.D. (University of California, San Diego)
• Roche conducted a phase 2 clinical trial to evaluate changes in glycemic control in overweight or obese adults with T1D treated with their drug acmopatide (CT-868).
• People treated with acmopatide demonstrated reduced HbA1c levels, weight, insulin dose, and blood pressure compared to placebo.
• Despite these improvements, Roche decided to discontinue research into acmopatide and abandon plans for a phase 3 clinical trial.
• However, there are other companies studying GLP-1s in people with T1D. For example, Lilly has an ongoing clinical trial that is fully enrolled. Learn more below.

GLP-1 Receptor Agonists for Kids

• Presenter: Michelle Van Name, M.D. (Yale University)
• There is clear evidence in adults with T1D that GLP-1 receptor agonists can improve weight and glycemic control and reduce the risk of heart and kidney complications, and more clinical evidence is needed for the adolescent population.
• Adolescents with T1D could benefit from this class of drugs because they tend to have insulin resistance and live with overweight or obesity, and those who develop T1D earlier in life have a greater lifetime risk of long-term complications.
• Currently enrolling clinical trials (T1-DISCO and Obesity Complicating T1D: GLP-1 Analogue Anti-Obesity Treatment) in young adults living with T1D and obesity are investigating the impacts of GLP-1s on cardiovascular outcomes.
• Dr. Van Name’s mentor was Bill Tamborlane, M.D., a long-time champion for the T1D community and Breakthrough T1D supporter who recently passed away.

Look out for another article soon wrapping up days 3 and 4 of ADA 2026!

The FDA has approved Tandem’s Control-IQ+ technology for use in pregnancy with type 1 diabetes (T1D). This is the first-ever automated insulin delivery (AID) technology cleared in the U.S. for pregnancy with T1D—a major milestone for the T1D community! 

What is an Automated Insulin Delivery (AID) System?

An AID system has three main components: an insulin pump, a continuous glucose monitor (CGM), and an algorithm that lets these components communicate with each other to determine the best insulin dose to help keep blood sugar in range. 

Automated insulin delivery systems: 

• Are used in place of multiple daily injections (MDI) of insulin 
• Continuously measure blood-glucose levels and adjust insulin delivery automatically 
• Give less insulin when blood sugar is low and more insulin when blood sugar is high 
• Still require user input for meals and snacks and troubleshooting (called hybrid closed-loop) 
• Have been shown to improve time-in-range 

Tandem’s Control-IQ+ algorithm can be paired with the Tandem Mobi System or t:slim X2 insulin pump and is compatible with Dexcom’s G6/G7 and Abbott’s Freestyle Libre 3 Plus CGMs. Consider speaking with your healthcare provider if you are pregnant or planning to become pregnant to see if these options may be a fit for you. 

Using Technology to Manage Type 1 Diabetes During Pregnancy

As your body changes during pregnancy, so does your T1D management. Technologies like automated insulin delivery systems can give you more real-time information about your blood-glucose levels and patterns, help keep you in a tighter range, and reduce the risk of hyperglycemia, hypoglycemia, and long-term complications. 

The FDA’s decision to approve Control-IQ+ for pregnancy was based on the results from the CIRCUIT clinical trial. Pregnant women with type 1 diabetes who used Tandem’s Control-IQ+ technology spent around 3 more hours per day in the recommended blood sugar range for pregnancy (63-140 mg/dL) compared to those using a CGM and their usual method of insulin delivery (MDI or insulin pump). Even more, participants using Control-IQ+ had fewer low blood sugar events and less glycemic variability, and they reported better sleep quality. 

Right now, less than half of pregnant individuals with T1D achieve 70% or more time in the pregnancy-specific blood sugar range. The approval of Control-IQ+ technology has the potential to change this—meaning healthier pregnancies for both babies and soon-to-be moms. 

“During pregnancy, Control-IQ+ was a game-changer.

It helped me achieve more time in range, more predictable outcomes, and experience fewer highs and lows. It also reduced much of the mental burden and T1D-related anxiety that comes with having to constantly monitor and make adjustments, which allowed me to focus more on my overall health and my baby’s well-being. I’m grateful for Control-IQ+ helping me feel more confident and in control during my pregnancy and the healthy, safe delivery of my baby boy.”

Liz Walsh, Living with T1D for 35 years

Other Tips for a Healthy Pregnancy with T1D

Maintaining a healthy lifestyle can benefit both you and your baby throughout your pregnancy. There are extra considerations for pregnant individuals with T1D because changing hormone levels and insulin sensitivity throughout different stages of pregnancy can have significant impacts on blood sugar. Your insulin dose will likely increase during pregnancy, and using an AID system can help make this transition easier. 

Work together with your healthcare team to track and manage your blood sugar levels and make the necessary lifestyle adjustments to have the safest and healthiest pregnancy possible—both before and during your pregnancy. This includes eating right, staying active, getting good sleep, monitoring for complications, and maintaining good mental health. 

T1D Pregnancy Guide

Get guidance and support on all stages of pregnancy, from pre-pregnancy planning to juggling T1D as a new mom. 

Visit our Pregnancy Guide

Accelerating T1D Research for Pregnancy and Beyond

Breakthrough T1D research grants supported the development of the Control-IQ+ algorithm, and our advocacy supported the Special Diabetes Program, which funded its clinical testing.

We continue to support research into fully closed-loop AID systems to remove the need for user input around meals and troubleshooting so blood sugar management can one day be easier than ever. The work doesn’t stop until pregnant individuals with T1D have more options and can choose the best AID system that works for them.

Right now, we’re funding a clinical trial that will adapt and evaluate the Loop algorithm (as part of the twiist AID system) for pregnant women with T1D. Another Breakthrough-T1D funded study is collecting data from pregnant women with T1D to better understand changes in insulin sensitivity throughout pregnancy. This will then be used to help develop AID systems capable of adapting to pregnancy-specific changes in insulin requirements. 

By Sandy Vogt, Ph.D., and Kara Sweet

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. Let’s take 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!

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!