Odometer Pivots from 2023 to 2024

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.

DrugMechanismSubjects (Drug/ Placebo)AgeDiagnosed WithinGivenFDA Approvals
Olumiant® (baricitinib)JAK—critical to signaling pathways in immune and beta cells—inhibitor89 (59/30)10-30100
Oral tabletRheumatoid arthritis, hair loss (alopecia), COVID-19
Tzield™ (teplizumab)Anti-CD3 antibody, targeting a receptor on immune cells328 (217/111)8-176
Daily infusion for two 12-day coursesStage 2 (no symptoms) T1D
verapamilCalcium channel blocker that relaxes the muscles of your heart and blood vessels88 (47/41)8-171
Oral tabletHigh blood pressure (hypertension), chest pain (angina), certain heart rhythm disorders

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 JDRF-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 T1D.

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