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 to make a difference for members of the T1D community every single day. Here are some examples of how far we’ve come during the past year toward creating a world without T1D:
First Disease-Modifying Therapy Gets Approved
In a historic moment for T1D—and one that Breakthrough T1D had a hand in from the beginning, supporting research from the 1980s on—the U.S. Food and Drug Administration (FDA) approved Tzield™ (teplizumab-mzwv) for use in delaying the onset of clinical disease in at-risk individuals aged 8+. For the first time in history, Tzield will treat the autoimmune process behind T1D, altering the course of the disease. This is the first disease-modifying therapy—treatments that can slow, halt, or reverse the course of the disease—for T1D to be approved, but it won’t be the last. This breakthrough and others like it put us on the pathway to finding cures and, one day, preventing T1D entirely.
Making Insulin Affordable and Accessible for All Americans
With Breakthrough T1D and healthcare organizations’ support, Civica—a nonprofit pharmaceutical company—will manufacture and distribute three biosimilar insulins at $30 a vial or $55 for a box of 5 pens starting in 2024, regardless of insurance status. This will significantly lower the cost for millions of Americans and—most importantly—save lives. In addition, Breakthrough T1D advocates played a role in getting the Inflation Reduction Act signed into law, which caps the cost of insulin at $35 per month and removes insulin from the annual deductible for people on Medicare insurance.
Accelerating Cures with Stem Cell-Based Therapies
Joining forces in the quest for cures, Vertex has acquired ViaCyte, bringing together two of the biggest companies pursuing stem cell-based therapies for diabetes and allowing them to combine their resources, technologies, and more. Breakthrough T1D has been funding stem cell research advanced by both companies since the early 2000s. Vertex is now advancing a stem cell-derived islet replacement therapy for T1D. Grounded in the work of Breakthrough T1D-funded researcher Douglas Melton, Ph.D., it’s in human clinical trials and showing amazing results, with one participant being off insulin entirely.
T1D Index: A First-of-its-Kind Lifesaving Tool
Breakthrough T1D and other T1D-related organizations launched the T1D Index, a first-of-its-kind data simulation tool that offers the most accurate estimate of T1D ever created. The Index measures and maps how many people live with this condition in every country, the healthy years of life it takes from people living with T1D, the number of people who would still be alive today if they hadn’t died prematurely from type 1 diabetes complications, and our global strategy to reduce the impact of T1D.
Regulatory Approval of Several T1D Therapies and Technologies
Breakthrough T1D funds research to facilitate the development of new therapies and technologies to make day-to-day life with T1D easier, safer, and healthier. In the past year, we had a lot to be thankful for:
- Insulet Omnipod 5, the first tubeless artificial pancreas system, for ages 2+
- Dexcom G7® continuous glucose monitor (CGM) system for ages 2+
- Abbott FreeStyle® Libre 3 continuous glucose monitoring (CGM) system for ages 4+
- Senseonics Eversense® E3 CGM system, the first long-term implantable CGM, for ages 18+
A New Tool to Accurately Diagnose Type 1 in Adults
Misdiagnosing adults with T1D as having T2D is an all-too-common problem that can have tragic consequences, so Breakthrough T1D and IQVIA teamed up to develop an algorithm using artificial intelligence to identify people with T1D but misdiagnosed as T2D. The model can look at medical records and identify individuals who are diagnosed with T2D but actually have T1D, which could be used in real time to correct misdiagnoses, offering the potential for future development into a clinical decision support tool.
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 2023!
Today, Dexcom announced that the U.S. Food and Drug Administration (FDA) cleared the Dexcom G7® Continuous Glucose Monitor (CGM) system for ages 2+. People with diabetes will now have a smaller and more accurate CGM to help manage their blood-sugar levels.
“Breakthrough T1D is thrilled that the Dexcom G7 was cleared by the FDA,” says Breakthrough T1D Director of Research, Jonathan Rosen, Ph.D. “Rigorous research has shown many times over that CGM devices improve glucose control and other health outcomes. The Dexcom G7 features many notable improvements that are aligned with Breakthrough T1D’s goal of people with type 1 diabetes having access to effective, convenient therapies.”
G7 Enhancements
Smaller Profile, Easier Insertion
The G7 is 60% smaller than the G6 and has a simpler, one-step insertion process. The G6 has a transmitter that is reused for several weeks and inserted into each new sensor; the G7 is one disposable unit.
Shorter Warmup Time
A warmup period is required after the insertion of the sensor. During that time, the user does not have access to their blood-sugar levels. The warmup for the G6 is 2 hours, but only 30 minutes for the G7. That’s an extra 90 minutes per 10-day use sensor that the user has access to data with which to make decisions.
More Accurate
The G7 is more accurate than the G6. Dexcom published data from their pivotal trial demonstrating the safety and efficacy of the device. Of note is the G7’s Mean Absolute Relative Difference (MARD), which is a key metric used to evaluate CGM accuracy. MARD calculates the average difference between the glucose reading on the CGM with a blood-glucose measurement measured via a blood sample. The MARD for the G7 is 8.2% for sensors placed on the upper arm. That means the reading from the Dexcom is, on average, 8.2% different than the reading on the glucometer. This is an improvement over the G6’s 9% MARD for sensors on the abdomen (the G6 is not approved for use on the upper arm).
Breakthrough T1D has played a pivotal role in novel CGM development, as well as access and adoption, including supporting a clinical trial that conclusively demonstrated that CGM use improved health outcomes for people with diabetes. Dexcom G7 is one of several commercially available CGM systems now, which gives people with T1D the freedom to choose the tools and systems that are right for them.
Breakthrough T1D will continue to monitor the field and push for meaningful technological advancements, and we won’t ever stop fighting for affordability, choice, and coverage on our path to a world without type 1 diabetes.
Breakthrough T1D and Dexcom have a history of mutual support. Breakthrough T1D awarded a grant to Dexcom in 2015 and Dexcom provides Breakthrough T1D-funded studies with supplies. Breakthrough T1D did not fund research into the development of the G7.
Per Dexcom, they are working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible.
Dexcom anticipates the G7 will be available in early 2023.
Today, the U.S. Food and Drug Administration (FDA) weighed the evidence for teplizumab to delay type 1 diabetes (T1D) in at-risk individuals, and the T1D community got a big win: Approved, under the brand name Tzield™! Tzield (teplizumab-mzwv) is the first disease-modifying therapy for individuals at-risk for developing T1D. (At-risk means that they exhibited 2+ T1D-related autoantibodies—antibodies against one’s own self—and their blood glucose is starting to be abnormal, but they have not yet become insulin dependent.)
For the first time in history, there is an approved therapy that addresses the autoimmunity behind T1D—not just the symptoms that it causes in 1.4 million Americans.
Aaron Kowalski, Ph.D., CEO of Breakthrough T1D, celebrated the decision—the first approved therapy that can slow, halt, or reverse the course of the disease—for T1D.
“A delay in the onset of type 1 diabetes will have a tremendous impact on the daily lives of people at risk for diabetes, their families, and the overall health system,” said Dr. Kowalski. “It would free them from the constant burden and stress of blood-sugar monitoring and insulin administration. It would free them from the worry and fear of short- and long-term complications, while giving them the opportunity to learn more about disease management. That is clinically meaningful.”
Tzield can start to address the stark unmet need for disease-modifying therapies and provide people at-risk for T1D and their families at least without the burden and complications this disease brings. Tzield and multiple potential disease-modifying therapies that Breakthrough T1D has invested research into put us on the critical pathway to finding cures and, one day, preventing T1D entirely.
Breakthrough T1D thanks the FDA for their thorough and thoughtful review of the evidence and data, showing that the benefits outweigh the risks to delay clinical T1D in at-risk individuals.
What It Means for the Community
A delay in onset will be a gamechanger for at-risk individuals. Dr. Cory Wirt has experienced this firsthand. She enrolled her daughter, Claire, who had biomarkers and was at-risk for developing T1D, in a clinical trial for Tzield 7 years ago. Today, she has yet to progress into clinical T1D.
“As a mom, I appreciate 83 months of not checking blood-sugars multiple times per day, worrying about life threatening lows, and balancing my child/teen’s independence with the importance of tight medical control,” said Dr. Wirt. “Not to mention the significant cost of supplies, office visits, and emotional stress. We don’t know how long the effects of the treatment will last, but every day without insulin has been a gift!”
Tracy Olsten is another parent who made the decision to enroll her daughter, Mikayla, in clinical trials for Tzield. “We know Mikayla has the biomarkers,” said Olsten. “We know the probability is high that she will develop T1D in her life. But a little bit more time to live her teenage, young adult, and adult years without injections and finger pokes.”
A Day Decades in the Making
The decision would simply not have been possible without decades of Breakthrough T1D work, from funding discovery research to clinical development to work with regulators. Breakthrough T1D had a hand in the development of Tzield from the very beginning:
- Breakthrough T1D gave a Career Development Award to Kevan Herold, M.D., who had just started his faculty-level career at The University of Chicago, in 1988-1990. He showed, in an early study, that he could prevent autoimmune diabetes with an anti-CD3 antibody (which, later, became a humanized version, Tzield). He has gone on to receive more than 15 grants from Breakthrough T1D 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. This was the first ever study in humans to show a delay in the onset of T1D.
- We funded clinical trials in recent-onset disease, which were published in 2002, 2005, and 2013, and a phase III trial run by MacroGenics (it was called MGA031 at the time). MacroGenics received a Breakthrough T1D Industry Discovery and Development Program grant from 2006-2011.
- In 2012-2019, we funded, with the National Institutes of Health (NIH), the Immune Tolerance Network—an international clinical research consortium—that did a clinical trial of Tzield and identified who is likely to respond to the drug.
- Breakthrough T1D has also been a longstanding and passionate advocate for the Special Diabetes Program (SDP), an NIH program funded by Congress that enabled the creation of TrialNet—the largest clinical network for T1D. In 2010, with NIH, Breakthrough T1D, and the American Diabetes Association funds, TrialNet ran the clinical trial of Tzield in at-risk individuals, led by Dr. Herold.
The Breakthrough T1D T1D Fund made a strategic investment in Provention Bio in 2017 that brought the company into T1D for the first time. That investment has helped catalyze hundreds of millions of dollars toward clinical development, regulatory work, and launch preparation that made this moment possible.
Dr. Kevan Herold is one of the pioneers who began this research. Here are his thoughts on this momentous day:
“The story with the clinical use of teplizumab began with a Breakthrough T1D grant to support a trial in patients with new onset type 1 diabetes more than 2 decades ago,” said Dr. Kevan Herold, Yale School of Medicine. “The success of this initial study planted a seed that led to further studies and support from the NIH.
“The recent decision represents a turning point in the field. First, it identifies a way in which an immune therapy to stop the disease process might be combined with cell replacements in those with type 1 diabetes. It also suggests that it is time to more broadly screen to identify those at risk for type 1 diabetes, since now there is a therapy that can change its course.”
The success of Tzield—the first disease-modifying drug for T1D—is something that the T1D community, Breakthrough T1D, and other like-minded nonprofits, companies, consortia, and regulators should be gratified and proud of—but our work to find cures continues full steam ahead. We have multiple cures therapies in the pipeline today whose path to market became a little clearer with this approval. We are moving ever closer to a world without this disease, and Tzield receiving approval is one gigantic step along the way.
It’s worth celebrating every time the FDA approves a device that makes is easier for people with type 1 diabetes (T1D) to manage their disease. The announcement fits that bill. The FDA cleared the Abbott FreeStyle Libre 3 continuous glucose monitor (CGM) for children and adults ages 4 and up with diabetes, giving people additional choice for devices.
Another Tool in the Toolbox
CGM technology has revolutionized the treatment and management of T1D. Ever since the landmark 2008 study, funded by Breakthrough T1D, that showed the benefits of CGM, their adoption has significantly increased in type 1 and is also increasing in type 2 diabetes. And, in that time, the devices have become increasingly accurate, easier to insert, more convenient to use, and covered by payers.
Tools like this will help people with T1D do better until cures are realized.
Specs
FreeStyle Libre 3 is an evolution of the FreeStyle Libre 2. It has many of the same features as its predecessor; it is approved for use on the arm, transmits data every minute to a smartphone via an app for both iOS and Android; and it features several notable improvements. This includes:
- A 70% smaller sensor. Per Abbott, this device is the size of two pennies stacked on top of each other.
- A Mean Absolute Relative Difference (MARD) of 7.9%. MARD is a key metric used to evaluate CGM accuracy by comparing CGM values to an established blood glucose test. Per Abbott, the Freestyle Libre’s MARD of 7.9% makes it the first CGM to have a MARD below 8%.
- Bluetooth range of up to 33 feet.
“Breakthrough T1D is thrilled that the Abbott FreeStyle Libre 3 received clearance from the FDA,” says Breakthrough T1D Associate Director of Research, Jonathan Rosen, Ph.D. “Rigorous research has shown many times over that CGM devices improve glucose control and other health outcomes. A major priority for Breakthrough T1D is for people with type 1 diabetes to have access to and choice of effective, convenient technology for glucose management, and this is a step forward in that direction.”
Breakthrough T1D—A Key Driver of CGM
Breakthrough T1D has played a pivotal role in novel CGM development, as well as access and adoption, including supporting a clinical trial that conclusively demonstrated that CGM use improved health outcomes for people with diabetes. Once it becomes available in the coming months, FreeStyle Libre 3 will be one of several commercially available CGM systems, giving people with T1D the freedom to choose the tools and systems that are right for them.
Breakthrough T1D will continue to monitor the field and push for meaningful technological advancements, and we won’t ever stop fighting for affordability, choice, and coverage on our path to a world without T1D.
Additionally, FreeStyle Libre 3 is the CGM component of an automated insulin delivery (AID) system, also referred to as artificial pancreas system, currently being developed in Europe by CamDiab and Ypsomed. Breakthrough T1D funded Roman Hovorka, Ph.D., of the University of Cambridge and Director of CamDiab, from 2006-2019 to develop the algorithm, which is approved in Europe and UK, in that system.
