Leading researchers gathered in Long Beach, California, for the 16th annual meeting of the Network for Pancreatic Organ Donors with Diabetes (nPOD), which took place from February 19 through 22. nPOD is now the world’s largest tissue bank dedicated to the study of the human pancreas in type 1 diabetes (T1D), and researchers, clinicians, people with T1D, and other leaders in the diabetes space attended—more than 200—to hear results from the latest advances using nPOD samples.

Here are some of the highlights:

• Breakthrough T1D staff Esther Latres, Ph.D., vice president of research at Breakthrough T1D, and Josh Vieth, Ph.D., director of research focusing on disease-modifying therapies, co-chaired a session on the cellular mechanisms in and around T1D:
• • JDRF-funded Tim Tree, Ph.D., presented on islet-specific immune responses, with the goal of developing a tool to measure them in clinical trials. He discovered that islet-specific immune cells have distinct characteristics and pointed to the potential for correlation of immune cell characteristics with (i) age of onset, (ii) clinical progression, and (iii) genetic protection.

• • Melanie Shapiro, Ph.D., who has a Breakthrough T1D postdoctoral fellowship, identified an immune cell receptor pattern in blood moving throughout the circulatory system (as opposed to blood in a specific organ, like the pancreas) that was augmented in T1D, compared to blood that was non-T1D. This pattern was used to run multiple analyses, and all of the associations showed increased frequency of this pattern and gene mutations for T1D.

• • Carla Di Dedda, Ph.D., presented on her Breakthrough T1D grant on the glucose transporter GLUT1. Seven to eight percent of pancreas transplant recipients have a recurrence of T1D without rejection of their organ donation, and Dr. Di Dedda focused on GLUT1 as a culprit. She found that in people with T1D, immune cell proliferation was significantly reduced when GLUT1 was blocked, which will be instrumental in future research on the roles of GLUT1 in T1D.
• Miguel Medina-Serpas, who is a graduate student with Todd Brusko, Ph.D.—who received early-career scientist grants from 2008 through 2017 from Breakthrough T1D and three grants since—presented on visual-spatial gene expression on paired pancreas and lymph node slices. He found that it could reliably identify functional compartments of the pancreas. This could help to validate gene targets for therapeutic use.
• Esra Karakose, Ph.D., from the laboratory of Andrew Stewart, Ph.D., at the Icahn School of Medicine at Mount Sinai, focused on the action of beta cell regenerative drugs and which subtypes are responsible for treatment. Her lab found that the most responsive is the cycling alpha cell, which cluster between alpha and beta cells. She explained that cycling alpha cells become “beta-like cells” in response to treatment with the drugs DMSO and harmine, which may restore the beta cells that are lost in people with T1D.

Since being established in 2007 with a $7 million grant from Breakthrough T1D, nPOD has collected and processed more than 50,000 tissue samples from organ donors who had or were at increased risk for T1D. nPOD is conducting more than 250 studies to unlock the mysteries of the human pancreas. For more information on nPOD, you can visit their website here.

You are helping us advance toward preventing, treating, and—one day—curing T1D. Find out more about Breakthrough T1D here.

Leading researchers from around the world will gather for the 16th annual meeting of the Network for Pancreatic Organ Donors with Diabetes (nPOD), taking place from February 19-22 in Long Beach, California. The latest advances—using nPOD samples—will be discussed, including:

• Enhanced T Cell Receptors: There are several presentations on T cell receptors (TCRs)—which recognize a foreign substance and cause the T cell to attack—to restore immune tolerance in T1D. Immunocore, a company with an investment from the Breakthrough T1D T1D Fund, will present on ImmTAAI, a TCR that binds to the beta cell with an antibody that down-regulates the immune system. Also with support from the T1D Fund is Abata Therapeutics, which will present on their TCR that will restore immune tolerance by bringing regulatory T cells to the islet cells and promote immune suppression.

Since it was established in 2007 with a $7 million grant from Breakthrough T1D, nPOD has collected and processed more than 50,000 tissue samples from organ donors who had or were at increased risk for T1D, and has provided, without cost, these tissues to researchers around the world.

• Change the Current Staging Model: In a Breakthrough T1D-support-bonanza, going back to 1992 with a postdoctoral fellowship to Alberto Pugliese, M.D.—who is now the co-director of nPOD—we will hear from several investigators who will debate on when T1D begins and whether we should modify the current staging model. The current staging model has three parts: Stage 1 is the presence of 2+ autoantibodies—antibodies against one’s own body—but blood sugar is normal; Stage 2 is 2+ autoantibodies and the blood sugar is abnormal; Stage 3 is the onset of clinical symptoms. We can’t wait to hear the outcome of this discussion!
• Clinical Trials: Breakthrough T1D staff Esther Latres, Ph.D., vice president of research at Breakthrough T1D, and Josh Vieth, Ph.D., director of research focusing on disease-modifying therapies, are co-chairing a session on clinical trials. Breakthrough T1D-funded Tim Tree, Ph.D., will present on a test to determine islet-specific T cells; Melanie Shapiro, Ph.D., who has a Breakthrough T1D postdoctoral fellowship, will discuss immune risk and changes to the TCR repertoire; Carla Di Dedda, Ph.D., will present on her Breakthrough T1D grant on the glucose transporter GLUT1; and Guido Sebastiani, Ph.D., will discuss microRNAs—which play an important role in regulating gene expression—associated with T1D.

Keep up with the latest updates and exciting news from the nPOD annual meeting on Facebook (@myJDRF), X (formerly Twitter) (@JDRF), and LinkedIn.

We have many reasons to celebrate in the type 1 diabetes (T1D) community. First and foremost, we celebrate YOU. Your support of our efforts is inseparable from the tremendous progress we’ve seen in accelerating cures, improving lives, and advocating for people with T1D and their loved ones.

We celebrate the impact and influence that you have made in research and advocacy. All will make a difference for members of the T1D community. Here are 10 advances over the past year that Breakthrough T1D is proud of.

1. Disease-Modifying Therapies: New Options for New-Onset T1D

In several Breakthrough T1D-supported clinical trials, disease-modifying therapies—treatments that can slow, halt, or reverse the course of the disease—demonstrated that they could slow progression in new-onset T1D. Compared with placebo, participants had significantly greater stimulated C-peptide levels (a measure for insulin secretion), improved blood-sugar variability and time-in-range, and lower insulin doses. This is clinically significant as better beta cell function in new-onset T1D is associated with better long-term outcomes and lower risk of diabetes-related complications and low blood-sugar events.

2. Approval of the First Cell Replacement Therapy

In a historic moment for T1D, the U.S. Food and Drug Administration (FDA) approved Lantidra™, the first cell therapy to be authorized in the United States. It is approved for the treatment of adults with T1D who are unable to approach average blood-sugar levels due to current, repeated episodes of severe low blood sugar, called severe hypoglycemia. Lantidra is made from cadaveric donor islets, which are in short supply, and requires immunosuppressive drugs to prevent transplant rejection—all which Breakthrough T1D is working to overcome through its cell therapy program.

3. Transplantation, One Without the Need for Immunosuppression 

Vertex Pharmaceuticals—which acquired Semma Therapeutics in 2019 and ViaCyte in 2022, both of which had Breakthrough T1D or Breakthrough T1D T1D Fund support—is making major headway in its goal of developing stem cell-derived replacement therapies for T1D. It has a clinical trial of VX-880—it’s first cell therapy for T1D, with immunosuppressive drugs—with three out of six people being off insulin entirely, and VX-264, using a protective device which averts the need for immunosuppression.

Vertex is now collaborating with the company Lonza to build a dedicated facility that will support the manufacture of Vertex’s cell therapy portfolio for T1D—further investing in cures for the disease.

4. Making Insulin Affordable and Accessible for All Americans

Breakthrough T1D and partners are supporting nonprofit pharmaceutical company Civica, which will launch three biosimilar insulins—glargine (Lantus®), lispro (Humalog®), and aspart (Novolog®)—that will cost no more than $30/vial or $55/box of five pens, regardless of insurance status. Civica plans to file for FDA approval of the first of these insulins in 2024.

In another big advance, the top three insulin manufacturers—Eli Lilly, Novo Nordisk, and Sanofi—announced major cuts to their insulin prices. A major catalyst, in addition to Civica, was the Inflation Reduction Act (IRA), which caps insulin costs at $35/month for people covered by Medicare. Breakthrough T1D did not stop fighting when the IRA passed, continuing to pressure these companies to lower their prices.

Breakthrough T1D will not stop until everyone has access to insulin at a predictable, affordable price.

5. Regulatory Approval of Several Artificial Pancreas Systems

• Tandem Mobi, a miniature-sized insulin pump, for use with Tandem’s Control-IQ™ technology and a compatible continuous glucose monitor (CGM), 6+ years
• Medtronic MiniMed™ 780G artificial pancreas system, 7+ years
• iLet® insulin pump and algorithm, for use with a compatible CGM, to form the iLet Bionic Pancreas, 6+ years
• Tidepool Loop, an automated insulin dosing app, that will be used, eventually, with commercially available insulin pumps and CGMs, giving people greater potential to choose the technology that works for them

These technologies are leading to better health for people with T1D by reducing dangerous highs and lows, improving time-in-range, allowing for healthy pregnancies, and even leading to better sleep.

6. Could “Miracle” T2D Medications Work for T1D?

SGLT inhibitors (such as Jardiance®) and GLP-1 medications (such as Ozempic®) seem to be the modern “miracle” drugs for people with type 2 diabetes (T2D). They can lower blood-sugar levels, lead to weight loss, and lower the risk of major heart and kidney disease events. Breakthrough T1D is funding numerous studies to investigate whether these drugs can work for T1D without increasing the risk of dangerous highs or lows in blood sugar.

Breakthrough T1D has funded complications research since we were established, awarding one-third of our grants to find the underlying causes of and treatments for heart, kidney, eye, and other T1D-related diseases.

7. Pregnancy + T1D

Most women with T1D struggle to reach the recommended blood-sugar targets when they are pregnant. But according to a new study, an artificial pancreas system helped to substantially reduce maternal blood sugars throughout pregnancy—benefiting the mother and the baby. Published in The New England Journal of Medicine, the study authors say that—as a result of these findings—this technology should now be offered to all pregnant women with T1D to help improve maternal blood sugars.

8. Once-Weekly Insulin

Results from Novo Nordisk’s phase III ONWARDS 6 clinical trial were reported. This was the first and only large study to date to investigate once-weekly insulin in people with T1D. There were 582 participants, and Novo Nordisk’s weekly insulin icodec was comparable to degludec (brand name Tresiba®), Novo Nordisk’s ultra-long-acting daily insulin. There was, however, a significantly higher rate of low blood sugar in people receiving icodec. Many participants noted, though, that they preferred once-weekly insulin over once-daily insulin, citing “frequency of injections” (70%) and “ease of use” (52%).

9. Anti-Viral Drugs Against Enteroviruses

The first findings from the Breakthrough T1D-funded clinical trial (DiViD) to test two anti-viral drugs against enteroviruses—common viruses that cause cold-like symptoms and may be linked to the development of T1D—in children with new-onset T1D. Those who received the anti-viral medication maintained a higher level of insulin production after one year than those who did not take the medication, demonstrating that the treatment can slow the progression of T1D. The results were published in Nature Medicine.

10. The First Study to Show Correlation Between Time-in-Range and Complications

In a Breakthrough T1D-funded study, scientists analyzed CGM data; 92 people were without a diagnosis of diabetic eye disease and 71 of them were. People with diabetic eye disease had an average time-in-range of 52%, while the control group had a time-in-range of 62%—meaning that every 5% point decrease in time-in-range was associated with a 16% risk increase in diabetic eye disease. What does this mean? 1. It’s the first longitudinal study to demonstrate the association between CGM metrics and complications, and 2: Time-in-range could become closer to realizing its potential application in T1D management and clinical trials.

Go Forward

Your partnership is inseparable from these advances and many more. On behalf of our community, thank you for going forward—for more progress, more advancements, and more access—for everyone impacted by type 1 diabetes.

We are excited for the progress that awaits us in 2024!

In a Breakthrough T1D-funded clinical trial, published in the renowned New England Journal of Medicine, Thomas Kay, M.B.B.S., Helen Thomas, Ph.D., and others demonstrated that baricitinib—a JAK inhibitor, which is critical to signaling pathways within both immune cells and beta cells in type 1 diabetes (T1D)—preserved beta cell function in the disease.

In 60 newly diagnosed children and young adults, baricitinib:

• Preserved insulin production, as estimated by C-peptide
• Improved blood-sugar variability and time-in-range, using a continuous glucose monitor (CGM)
• Decreased the requirement for external insulin
• Was well tolerated

The effect of baricitinib was achieved using a single daily oral tablet, and it’s the first immunotherapy trial to suggest a benefit on CGM measures. (Verapamil, a once-a-day tablet, also preserved beta cell function, but without improvement in CGM measures or insulin requirement.)

What Comes Next?

Baricitinib is not an FDA-approved therapy for people with T1D, but Breakthrough T1D has multiple lines of inquiry to make sure that this and other disease-modifying drugs get to the hands of people with the disease. There are several clinical trials that Breakthrough T1D is exploring to see if baricitinib can be effective if used in conjunction with other therapies, such as Tzield™ (teplizumab-mzwv) or verapamil, in presymptomatic disease, or in longer duration.

But this adds to the armamentarium of potential curative therapies, and Breakthrough T1D is excited to be a part of the team that made this advance possible.

Leading diabetes researchers gathered for the annual conference of the International Society for Pediatric and Adolescent Diabetes (ISPAD), which took place from October 18-21 in Rotterdam, The Netherlands, and had more than 1,600 attendees—its largest-ever audience.

More than 45 studies were presented by Breakthrough T1D researchers, funded now or in the past, working to find cures for type 1 diabetes (T1D) and improve the lives of those living with the condition today. Here are some of the highlights:

• Presented by Kevan Herold, M.D., and published in the New England Journal of Medicine, the phase III PROTECT clinical trial investigated whether Tzield™ (teplizumab-mzwv) can slow the loss of beta cells and preserve beta cell function in newly diagnosed (stage 3 T1D) children and adolescents ages 8-17. Per the study results, it can. Participants treated with Tzield had:
  • Significantly greater stimulated C-peptide levels (a measure for insulin secretion) compared with placebo
  • Tended to use lower insulin doses to meet glycemic goals
  • Experienced higher rates of predefined clinical remission, defined as participants who achieved HbA1c ≤6.5% and insulin daily dose ≤0.25 U/kg/day
  • Conclusion: Tzield has the potential to slow the progression of Stage 3 T1D and improve clinical parameters in newly diagnosed individuals.

Dr. Herold has been supported by Breakthrough T1D since the late 1980s. In his research, he showed that he could prevent autoimmune diabetes with an immune-modifying antibody (which, later, became a humanized version, Tzield) and was the lead on the clinical trial that demonstrated that Tzield could delay the onset of T1D in people almost certain to develop the disease. In November 2022, Tzield was approved by the FDA to delay the onset of the disease (Stage 3) in at-risk (Stage 2) individuals ages 8+.

• In a joint ISPAD-Breakthrough T1D symposium about global pediatric diabetes development, we heard from Tom Robinson, who heads the T1D Index. The Index leverages machine learning models to estimate the incidence of T1D around the globe. According to the Index, in access to care and quality of life most significantly affect low- and middle-income countries. Robinson pointed to four key areas of intervention to address the global T1D crisis, which ISPAD and Breakthrough T1D are working to address:
  • Increasing diagnosis and screening efforts
  • Access to insulin and strips, as well as proper coaching for use
  • Device access
  • Facilitating prevention and cures

• Manuela Battaglia, Ph.D., discussed impediments in the T1D therapy research and development pipeline and how INNODIA—an international public-private partnership, with Breakthrough T1D and others support—is addressing the problem. Established in 2015, INNODIA was launched to accelerate the development of new disease-modifying therapies for T1D by fostering the creation of centers of excellence and by building a global network of members and experts. INNODIA now has four intervention clinical trials, paving the way for the development of novel treatments to prevent and find cures for T1D.
• In the complications space, Farid Mahmud, M.D., a Breakthrough T1D grantee since 2017, presented on the need for better blood biomarkers to earlier identify diabetic kidney disease. In his Breakthrough T1D-funded ATTEMPT clinical trial, which examines the impact of SGLT2 inhibitors (such as Jardiance®) on adolescents and young adults with T1D, he is investigating whether  decreasing how much  glucose is absorbed by the kidney is beneficial in diabetes-related complications. The study has already enrolled 98 out of 100 participants and is set to complete in mid-2024.

The next conferences we’ll be covering are the:

• Network for Pancreatic Organ Donors with Diabetes (nPOD), from February 19-22, 2024, in Long Beach, California
• Advanced Technologies & Treatments for Diabetes (ATTD), from March 6-9, 2024, in Florence, Italy (and online)

Stay tuned for a precap and recap of these terrific meetings!

In the past year, we’ve seen a turning point for type 1 diabetes (T1D) treatments and technologies. In improving lives, we have new artificial pancreas systems and continuous glucose monitors (CGMs), which make living with T1D more manageable and convenient. In the area of cures for T1D, we have—in a historic moment for T1D—the first disease-modifying therapy, Tzield (teplizumab-mzwv), for use in delaying the onset of clinical disease in at-risk individuals.*

But what about the approximately 60,000+ people in the United States who are diagnosed each year with new-onset T1D?

Results from a new clinical trial suggest that Tzield has the potential to slow the progression of T1D for them.

Presented by Kevan Herold, M.D., and published in the New England Journal of Medicine, the PROTECT clinical trial investigated whether Tzield can slow the loss of beta cells and preserve beta cell function as measured by C-peptide in newly diagnosed (stage 3 T1D) children and adolescents ages 8-17. Per the study results just announced, it can.

In a press release issued by Sanofi (who acquired Provention Bio in April 2023), the data showed that:

• Tzield met the study’s primary endpoint, significantly slowing the decline of C-peptide levels, compared to placebo
  • C-peptide is a biomarker for beta cell function
• Numerical trends favoring Tzield were seen in key secondary endpoints, whilst statistical significance was not achieved
• On average, people on Tzield required numerically fewer insulin units and had numerically higher time in range, compared to those on placebo
• Tzield has the potential to slow the progression of Stage 3 T1D in newly diagnosed individuals

“Tzield demonstrating effectiveness in a study of newly diagnosed children and adolescents is outstanding news,” said Sanjoy Dutta, Ph.D., Breakthrough T1D chief scientific officer. “Preserving beta cell function in individuals diagnosed with type 1 diabetes is a critical step towards cures and, crucially, is helpful in type 1 diabetes management in these people. Breakthrough T1D has believed in this therapy for decades and is continuing to study its potential uses in type 1 diabetes.”

“Thanks to Provention Bio and Sanofi’s ongoing commitment and dedication to individuals with type 1 diabetes, we now know that Tzield can benefit a new subset of the T1D population. Breakthrough T1D applauds all efforts aimed at finding cures and improving therapies for individuals with type 1 diabetes.”

Tzield is not yet FDA approved for individuals with stage 3 T1D. In Sanofi’s press release they say that they look forward to discussing this new data with the scientific community and regulatory authorities around the world.

Breakthrough T1D has supported the development of teplizumab for nearly 30 years, which includes contributions through research grants, federal funding via the Special Diabetes Program, a strategic investment by the Breakthrough T1D T1D Fund that brought Provention Bio into T1D for the first time, and more.

Breakthrough T1D is also currently pursuing multiple therapeutic approaches to cure T1D, and the T1D Fund has over 20 active cures programs in development.

*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.

Leading researchers from around the world will gather for the annual meeting of the International Society for Pediatric and Adolescent Diabetes (ISPAD). At this year’s meeting, which will take place from October 18-21 in Rotterdam, The Netherlands, more than 45 studies will be presented by Breakthrough T1D researchers, funded now or in the past, working to find cures for type 1 diabetes (T1D) and improve the lives of those living with the condition today. Let’s have a look:

• The first findings from the PROTECT clinical trial, which tested the disease-modifying therapy Tzield™ (teplizumab-mzwv) in children with new-onset T1D. The findings are being presented by Kevan Herold, M.D.— who Breakthrough T1D has supported since the late 1980s. In his research, Dr. Herold showed that he could prevent autoimmune diabetes with an immune-modifying antibody (which, later, became a humanized version, Tzield) and was the lead on the clinical trial that demonstrated that Tzield could delay the onset of T1D in people almost certain to develop the disease. In November 2022, Tzield was approved by the FDA to delay the onset of the disease in at-risk individuals.
• In a joint ISPAD-Breakthrough T1D symposium on global pediatric diabetes development, we will hear from Tom Robinson, who heads the T1D Index, the first-of-its-kind tool that provides the most accurate and comprehensive picture of how many people live with T1D in every country in the world. Joining Tom will be Graham Ogle, MBBS, FRACP, who will discuss the Life for a Child Program, an international aid program that provides life-saving support to children and youth with diabetes in developing countries.
• In a presentation by Line Wisting, Ph.D., we will get an update on the Breakthrough T1D-funded clinical trial testing a virtual eating disorder prevention program for young women with type 1. They have recruited approximately three-quarters of their planned 240, and we will get results on the first 6 months of the study. About two-thirds of young women with T1D develop eating disorders in their lifetimes, so this is a very important and timely topic.
• In a symposium sponsored by Sanofi, we will hear from Breakthrough T1D chief scientific officer Sanjoy Dutta, Ph.D., Thomas Danne, M.D.—who were both Breakthrough T1D postdoctoral fellows when they were at the Joslin Diabetes Center—and Kimber Simmons, M.D., M.S., as they discuss general population screening for T1D and how we can work together to help individuals and their families prepare for and potentially delay this chronic health condition.

Keep up with the latest updates and exciting news from the ISPAD annual conference on Facebook (@myJDRF), X (formerly Twitter) (@JDRF), and LinkedIn, with the hashtags #JDRFxISPAD and #ISPAD2023.

Leading researchers gathered in Hamburg, Germany, for the annual meeting of the European Association for the Study of Diabetes (EASD), which took place from October 2-6. Researchers, clinicians, and other leaders in the diabetes space from more than 120 countries attended—including experts from Breakthrough T1D and the Breakthrough T1D T1D Fund. The meeting featured more than 65 studies presented by Breakthrough T1D-funded researchers, funded now or in the past, working to find cures for type 1 diabetes (T1D) and improve the lives of those living with the disease today.

Research presented at this conference covered all areas of Breakthrough T1D’s research portfolio, from disease-modifying therapies to cell therapies to complications. Here are some of the highlights:

• Anti-Viral Drugs Against Enteroviruses: The first findings from the Breakthrough T1D-funded clinical trial (DiViD) to test two anti-viral drugs against enteroviruses—common viruses that cause cold-like symptoms and may be linked to the development of T1D—in children with new-onset disease were presented by Knut Dahl-Jorgensen, M.D., Ph.D. Those who received the anti-viral medication maintained a higher level of insulin production after one year than those who did not take the medication, demonstrating that the treatment can slow the progression of T1D. The results were published in Nature Medicine.
• Heart Disease: In an EASD/Breakthrough T1D symposium, co-chaired by our own CEO Aaron Kowalski, Ph.D., presenters shared their insights on cardiovascular risk in youth with diabetes. Janet Snell-Bergeon, Ph.D., MPH, who has received a Breakthrough T1D grant to examine insulin resistance in T1D, spotlighted novel biomarkers for heart disease. The “ABCs” of diabetes risk factor management are HbA1c, blood pressure, and cholesterol levels, however, decreasing HbA1c, for example, is oftentimes not sufficient to reduce heart disease in T1D. To further stratify youth, APOC3 and GDF-15 proteins could be used as heart disease biomarkers. Ongoing research is integrating these into existing prediction models to verify their use as biomarkers for youth with T1D. If we can detect heart disease earlier, we can do earlier interventions, which can lead to the reversal of the early indicators of issues. In short, biomarkers let us see it earlier and act earlier.
• Also presenting on heart disease—which causes approximately three out of every four deaths in people with T1D—were members of the SFDT1 study, a Breakthrough T1D-funded research program that will follow 15,000 people with T1D over 30 years to better understand the factors associated with heart disease complications in T1D. This will offer new opportunities to better advance diabetes management, leading to more personalized prevention and improved quality of life.
• Stem Cell-Derived Therapy: In the summer of 2021, Vertex Pharmaceuticals launched its clinical trial of VX-880, a stem cell-derived islet replacement therapy in T1D for individuals with hypoglycemia unawareness, in combination with immunosuppressive therapy to protect the cells from rejection. To date, six participants have received this therapy, and three are now insulin independent. The phase I/II study is on Part C,  where individuals receive a full dose of the therapy, and has opened multiple additional sites around the world.
• Once-Weekly Insulin: Novo Nordisk had results from its phase III ONWARDS 6 clinical trial, the first and only large study to date to investigate once-weekly insulin in people with T1D. There were 582 participants, and Novo Nordisk’s weekly insulin icodec was comparable to degludec (brand name Tresiba®), Novo Nordisk’s ultra-long-acting daily insulin. There was, however, a significantly higher rate of low blood sugar in people receiving icodec. Many participants noted, though, that they preferred once-weekly insulin over once-daily insulin, citing “frequency of injections” (70%) and “ease of use” (52%).
• Pregnancy + T1D: Most women with T1D struggle to reach the recommended blood-sugar targets when they are pregnant. But according to a new study presented by Helen Murphy, M.D., FRACP, an artificial pancreas system helped to substantially reduce maternal blood sugars throughout pregnancy. Published in The New England Journal of Medicine, the study authors say that—as a result of these findings—this technology should now be offered to all pregnant women with T1D to help improve maternal blood sugars.
• And, finally, congratulations to Breakthrough T1D-funded investigators:
• • Åke Lernmark, M.D., Ph.D., received the 55th Claude Bernhard Medal, the highest award in recognition of contributions to the advancement of knowledge in the field of diabetes, for his role in dissecting the genetic and environmental causes of T1D;
  • Yuval Dor, Ph.D., received the 17th Albert Renold Prize, given for a member’s outstanding achievement in research on the islets and their relationship to diabetes; and
  • Roman Hovorka, Ph.D., received the EASD-Novo Nordisk Foundation Diabetes Prize for Excellence, which awards an internationally recognized researcher who has contributed significantly to advances in the understanding, prevention, and treatment of diabetes and its complications. Dr. Hovorka has been at the forefront of artificial pancreas research, developing the algorithm in CamAPS® FX, which is now available in 16 countries and is used by over 16,000 people.

The next conference we’ll be covering is the International Society for Pediatric and Adolescent Diabetes (ISPAD) 49th Annual Conference, from October 18-21 in Rotterdam, The Netherlands. Stay tuned for a precap and recap of this terrific meeting!

Leading researchers from around the world will gather for the annual meeting of the European Association for the Study of Diabetes (EASD). At this year’s meeting, which will take place from October 2-6 in Hamburg, Germany, 65 studies will be presented by Breakthrough T1D researchers, funded now or in the past, working to find cures for type 1 diabetes (T1D) and improve the lives of those living with the disease today.

EASD Highlights

• The first findings from the JDRF-funded clinical trial to test two anti-viral drugs against enteroviruses—a common virus that causes cold-like symptoms and may be linked to the development of T1D—in children with new-onset disease, presented by Knut Dahl-Jorgensen, M.D., Ph.D.
• Vertex Pharmaceuticals will present an update on the cell replacement therapy VX-880. We learned at the American Diabetes Association conference in June that six people had been treated, with two achieving insulin independence. We’re excited to hear more information on this groundbreaking trial!
• Chairing a session is our own CEO Aaron Kowalski, Ph.D., on a very important topic—heart disease in T1D youth and how to best detect it before children reach adulthood.
• And, finally, congratulations to Breakthrough T1D-funded investigators:

• • Åke Lernmark, M.D., Ph.D., who will receive the 55th Claude Bernhard Medal, the highest award in recognition of contributions to the advancement of knowledge in the field of diabetes, for his role in dissecting the genetic and environmental causes of T1D;
  • Yuval Dor, Ph.D., who will receive the 17th Albert Renold Prize, given for a member’s outstanding achievement in research on the islets and their relationship to diabetes; and
  • Roman Hovorka, Ph.D., who will receive the EASD-Novo Nordisk Foundation Diabetes Prize for Excellence, which awards an internationally recognized researcher who has contributed significantly to advances in the understanding, prevention, and treatment of diabetes and its complications.

The Albert Renold Prize has been given out annually since 2007. A total of 15 recipients have received Breakthrough T1D funding prior to winning the prize, including six investigators who received Breakthrough T1D early-career scientist grants. (Dr. Dor was a Breakthrough T1D postdoctoral fellow from 2003-2005 and a Breakthrough T1D Career Development Award from 2005-2010 and has received many more awards since.)

Stay Updated

Keep up with the latest updates and exciting news from the EASD Conference on Facebook (@myJDRF), X (formerly Twitter) (@JDRF), and LinkedIn, with the hashtags #JDRFxEASD and #EASD2023.

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

What Is Semaglutide?

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

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

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

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

Study Results

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

What Comes Next

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

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

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

GLP-1’s Are a Priority for Breakthrough T1D

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

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

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

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

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