The U.S. Food and Drug Administration (FDA) cleared the iLet® Insulin-Only Bionic Pancreas System, which is designed to autonomously determine and deliver insulin doses to control blood-sugar levels, for people 6 years of age and older with type 1 diabetes (T1D). It includes an algorithm and an integrated infusion pump, which communicates directly with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), enabling it to be an artificial pancreas, or automated insulin dosing (AID), system.

What’s new about this system? Ease-of-use. The iLet system is designed to have users enter only their weight for the iLet to initialize therapy. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver additional insulin for meals or corrections. (Users do have to say whether the amount of carbs in a meal is small, medium, or large, but the algorithm learns over time in response to their individual insulin needs.)

The submission was based on a multi-center randomized insulin-only iLet Bionic Pancreas pivotal trial, which tested the insulin-only configuration in 440 adults and children 6 years and older with T1D. The trial met all key endpoints, demonstrating improved outcomes over standard of care for people living with T1D:

There are now multiple artificial pancreas systems on the market: The Medtronic 670G (2016), Tandem Control-IQ™ (2019), Medtronic 770G (2020), Insulet Omnipod 5 (2022), Medtronic 780G (2023), and, now, the iLet® Insulin-Only Bionic Pancreas System. (Tidepool Loop, an app that contains an algorithm that automates insulin dosing, has also been approved, but it has not yet announced its insulin pump manufacturer.)

Breakthrough T1D Impact

Breakthrough T1D started the Artificial Pancreas Project over 15 years ago to ensure people with T1D have better, more innovative ways to manage their type 1 diabetes until there are cures. Our goal was to ensure life-changing options for people with T1D and a competitive ecosystem that drove continuous innovation. To date, Breakthrough T1D has funded more than $140 million in artificial pancreas research.

Through these grants, Breakthrough T1D supported the development of the algorithm and preclinical and early clinical research—in partnership with the Helmsley Charitable Trust—through grants to:

This is a win for the T1D community and provides people with T1D another option to improve daily blood-sugar management, until cures are found.

The Food and Drug Administration (FDA) recently approved the Medtronic MiniMed™ 780G artificial pancreas system for use in individuals 7 years and over. It provides automatic adjustments and corrections to blood-sugar levels every 5-minutes, and also correction doses, as part of its meal detection technology.

This is an evolution of the 670G, the world’s first artificial pancreas system, which was approved in 2016, and an updated version, 770G, which was authorized in the United States in 2020. (The 780G was approved in Europe in 2020.)

In the pivotal clinical trial:

The 780G is approved for use with the Medtronic Guardian 4 continuous glucose monitor (CGM). Unlike its predecessor, the Guardian 3, the Guardian 4 does not require fingerstick calibrations.

The 780G is also approved for use with the Medtronic Extended Infusion Set (EIS), which can be used for seven consecutive days (most infusion sets can be used for 3 days).

Per Medtronic, individuals will be able to pre-order the device on May 15 with an expected delivery in June.

Breakthrough T1D Impact

Breakthrough T1D’s strategy focuses on improving lives and cures through research and advocacy to accelerate therapies through the pipeline. Through these efforts, Breakthrough T1D developed a roadmap for artificial pancreas development with projections for next generation versions of the artificial pancreas. Manufacturers embraced the roadmap to guide their own research and development programs.

Breakthrough T1D has funded over $140 million to date in artificial pancreas research.

This is a win for the T1D community and provides people with T1D another option to improve daily blood-sugar management until cures are found.

Cynthia Rice, Breakthrough T1D’s Chief Mission Strategy Officer, will leave behind quite a legacy once she steps down from her role at Breakthrough T1D at the end of March 2023.

“In her time with Breakthrough T1D, she has led with strategic purpose and passion,” read Breakthrough T1D CEO Aaron Kowalski’s December 2022 memo announcing Cynthia’s decision to leave. “She has been an incredibly valuable partner to me, as well as staff and volunteers throughout the organization.”

During her tenure at Breakthrough T1D, she has helped bring the artificial pancreas project to life, has driven efforts to renew the Special Diabetes Program, and was a key player in Breakthrough T1D’s response to and handling of COVID-19—all with the partnership of our strategic staff and vast network of volunteers, who are the bedrock of our advocacy efforts.

“It’s possible—while challenging—to impact the research and development (R&D) ecosystem to improve options and outcomes for people living with chronic diseases like type 1 diabetes,” says Cynthia. “Defining goals, tapping into strengths, building capacities, and remaining determined in the face of obstacles are critical.”

And for nearly two decades, she has done just that at Breakthrough T1D.

“Leverage—enlisting others to our cause—is critical to our success and core to our organizational DNA, whether it’s engaging friends and families, company R&D heads, government officials, or foundation leaders,” Cynthia says.

The Artificial Pancreas Endeavor

From Left: Breakthrough T1D International Board of Directors member Claudia Graham, Ph.D., M.P.H.; Breakthrough T1D Chief Mission Strategy Officer Cynthia Rice; and Senator Susan Collins (R-ME). Left-click on image to slightly enlarge.

From Left: Breakthrough T1D International Board of Directors member Claudia Graham, Ph.D., M.P.H.; Breakthrough T1D Chief Mission Strategy Officer Cynthia Rice; and Senator Susan Collins (R-ME). Left-click on image to slightly enlarge.

Cynthia came to Breakthrough T1D in September 2005. Real-time continuous glucose monitors (CGMs) were in the early stages of development, with one approved just months prior.

Aaron Kowalski, Ph.D., who had come to Breakthrough T1D a year before and is now the CEO, and Jeffrey Brewer, a member of Breakthrough T1D’s International Board of Directors at the time, had just spent six months interviewing academic scientists, corporate executives, and other like-minded players to figure out whether Breakthrough T1D wanted to take on the development of an artificial pancreas. There were many barriers, and companies were very wary of getting involved.

In the interviews, it became clear that despite the hesitation among companies, there was significant potential benefit for the T1D community in pursuing artificial pancreas technologies. The leadership—needed to foster a therapy roadmap, research funding, regulatory pathway, and health care access—just wasn’t there.

Breakthrough T1D changed that. We made it a priority, bringing not only our research funding, but also our powerful advocacy forces, to speed the development of these devices.

“The goal of multiple artificial pancreas systems, with ongoing innovation, drove our strategy,” says Cynthia, “and we took actions early on with that goal in mind, utilizing our strengths, building new capacities and relationships, and battling doggedly to overcome obstacles.”

Overcoming the Obstacles

Among the first obstacles was that the benefits of continuous glucose monitoring in the management of T1D had only been shown in small studies. In 2008, a Breakthrough T1D multi-site randomized control clinical trial showed that people with T1D who used the devices experienced significant improvement in blood-sugar control. This was instrumental to CGM coverage and laying the groundwork for the artificial pancreas system to come to fruition and be covered by the healthcare system.

Another obstacle was linking together the two main components of a closed-loop artificial pancreas system—the glucose sensor and an insulin pump. Breakthrough T1D established the Artificial Pancreas Consortium, which connected researchers from several different laboratories to develop the computer algorithms so that the machines could “talk” to each other and then be commercialized, as necessary.

A third obstacle—perhaps the most challenging of them all—required engaging government, regulatory, and health care groups.

Breakthrough T1D worked with researchers, insurance companies, the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), Medicare, and Congress on regulatory and coverage issues. When the first artificial pancreas system came on the market in 2016, the T1D community was more than ready for the life-changing T1D management it offered.

“Seeing the artificial pancreas go from concept to reality, which is helping so many people keep their blood-sugar management in control, is what makes Breakthrough T1D and all of the advocacy volunteers—who sent an email, made a call, signed an action alert, or met with their Member of Congress—very proud of this historic achievement and the impact that these will have on the individual lives of those with type 1 diabetes,” Cynthia adds.

The Special Diabetes Program (SDP)

The Special Diabetes Program

Cynthia Rice (far right, fifth row from the back), Breakthrough T1D volunteers, and Delegates at Children’s Congress 2013 with then-Vice President of the United States Joseph R. Biden (center). Left-click on image to slightly enlarge.

In 1997, with the bipartisan leadership of White House Chief of Staff Erskine Bowles and Speaker Newt Gingrich, Congress created the Special Diabetes Program (SDP), which annually allocates $150 million for T1D research at the NIH. Breakthrough T1D is the chief advocate of the SDP.

The SDP has been instrumental to some of the greatest advancements in the history of T1D—including research that led to artificial pancreas systems and the recent FDA approval of the first-ever drug that can delay onset of T1D, Tzield™ (teplizumab-mzwv).

Since its inception, the SDP has invested $3.4 billion into T1D research. The program’s success and continued renewal is the result in part of hundreds of Breakthrough T1D advocates meeting with their Members of Congress each year to discuss the importance of the SDP.

“Sustaining bipartisan support to renew again and again in challenging times in Washington is thanks to the amazing volunteer-staff partnership in advocacy,” says Cynthia. “This is now paying enormous dividends, not only in the artificial pancreas systems, but in cures therapies, including disease-modifying and cell therapy treatments.”

Breakthrough T1D’s Unique Strengths

“Breakthrough T1D has two strengths that are rare,” says Cynthia. “The first is scientific expertise, convening the best and brightest across fields and generating ideas to solve the biggest problems. The second is community passion, to influence R&D priorities, regulatory pathways, and health care access and enlist government leaders to take action for our cause.”

She adds: “Breakthrough T1D has harnessed these strengths and organized the community, leading to our higher-level power: Influence.”

“It’s not only possible but realizable for a small band of determined people, starting with our founding moms, to tackle and overcome big obstacles,” says Cynthia. “As long as we organize ourselves well, deploy smart strategies, and develop an advocacy message that people can get around, Breakthrough T1D will continue to have the impact that has historically been the pillar of our advocacy work.”

“More broadly, strong patient advocacy strengthens our health system and our society and helps align incentives in research, development, and health policy to benefit the people affected by the disease,” says Cynthia. “All of us as leaders should be thinking about what else we can do to help strong, independent patient communities come together and thrive as advocates, which I hope to do when I return to the health sector in 2024 after a sabbatical.”

A Legacy of Women Leaders

Breakthrough T1D was founded by women, has mostly women staff and volunteers, and counts numerous successful and influential women among its current and past leaders and supporters.

Women who, like Cynthia Rice, share Breakthrough T1D’s vision for a world without T1D and who will stop at nothing to turn that vision into reality.   

“From the majority staff and volunteer base, to our women founders, to our international chair Mary Tyler Moore, to our advocates, fundraisers, and scientists,” says Cynthia, “Breakthrough T1D, as an organization, shows the power women can have to impact their world.”

Members of Breakthrough T1D's Grassroots Leadership Team (GLT)

Members of Breakthrough T1D’s Grassroots Leadership Team (GLT) along with members of Breakthrough T1D’s Advocacy Team, including Cynthia Rice (ninth person in from the right) at Breakthrough T1D Government Day 2023. Left-click on image to slightly enlarge.


Cynthia Rice at Government Day 2023.

Cynthia Rice at Government Day 2023. Left-click on image to slightly enlarge.

The U.S. Food and Drug Administration (FDA) authorized the Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D). The Loop is, essentially, an algorithm that can, eventually, be used to work with commercially available insulin pumps and continuous glucose monitors (CGMs). The goal of the interoperable design: Provide flexibility for users and their healthcare teams to choose the compatible components that work best for them in managing their care.

It will be available as an app on iOS, to enable insulin delivery from a compatible Apple Watch. Tidepool has not yet announced its initial launch device partners, but the company has a development partnership with Dexcom and additional yet-to-be-named medical device companies for future inclusion of their components with the Tidepool Loop platform.

Breakthrough T1D Impact

Breakthrough T1D started the Artificial Pancreas Project over 15 years ago to ensure people with type 1 diabetes have better, more innovative ways to manage their T1D until there are cures. Our goal was to ensure life-changing options for people with T1D and a competitive ecosystem that drove continuous innovation. To date, Breakthrough T1D has funded more than $140 million in artificial pancreas research.

Through these grants, Breakthrough T1D supported the development of the algorithm and other open source programs—in partnership with the Helmsley Charitable Trust—through grants to Tidepool.

This is a win for the T1D community and provides people with T1D another option to improve daily blood-sugar management, until cures are found.

Here is Aaron J. Kowalski, Ph.D., announcing the approval, highlighting Breakthrough T1D’s role in the research and regulatory process, and reiterating that people with T1D should connect with their physician about the treatments best for them:

To learn more, visit the Tidepool Loop website.

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 T1D 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:

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 T1D.

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:

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: 

“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. 

Learn more at Abbott.   


After nearly 500 meetings with Members of Congress, Breakthrough T1D 2019 Government Day has officially come to a close. Over the course of four days, 175 grassroots leaders from across the country came to Washington, D.C. to advocate for the top issues affecting the type 1 diabetes (T1D) community. These issues, outlined in the Breakthrough T1D 2019 Advocacy Agenda, include renewing the Special Diabetes Program (SDP), insulin affordability, healthcare principles, and strong funding for the National Institutes of Health (NIH) and Food and Drug Administration (FDA).

“This year, there is increased visibility on the issues facing the T1D community,” says Stefanie Sonico, National Chair, Grassroots Leadership Team. “We have the unique opportunity to advocate for priority issues, like the rising costs of insulin and renewing the Special Diabetes Program. We’re making sure these are priorities for our Members of Congress.”

Kicking Off the Special Diabetes Program Renewal Campaign

The campaign to renew the Special Diabetes Program is officially off and running. This groundbreaking program, which expires on September 30, 2019, directs $150 million to T1D research annually through NIH. Renewing this program is Breakthrough T1D’s top legislative priority, and paramount to achieving our vision of a world without T1D.

While on Capitol Hill, Breakthrough T1D Advocates called on their Members of Congress in the House and Senate to sign on to letters in support of the SDP– a critical first step in gaining support for its renewal.

“The SDP is responsible for incredible research,” says Randall Barker, Advocacy Team Chair for West Texas. “The one advancement I’m most excited about is the artificial pancreas, which my daughter has been lucky enough to use. Continued funding for this program will further advance more technology which will improve the lives of everyone with T1D–like my daughter.”

The Cost of Insulin

Everyone with T1D should have access to insulin at a reasonable, predictable cost, and Breakthrough T1D is committed to working with insulin manufacturers, health insurance providers, pharmacy benefit managers (PBMs) and employers to make this a reality.

Breakthrough T1D believes that rebates are a key factor in the soaring costs of insulin. Eliminating them both in government programs, like Medicaid and Medicare, and in private insurance has the potential to lower the costs and make insulin more affordable for the millions who need it.

Breakthrough T1D Advocates asked their Members of Congress to support both administrative and congressional actions that would eliminate rebates.

“I’m excited to be having the discussion around insulin affordability,” says Michelle Freedman, Grassroots Leadership Team member from Oregon. “Back home in our communities, we’ve been having this conversation with our families and friends for years. Having the opportunity to speak now with Congress is empowering, and we can make a difference.”

If you are struggling with the cost of insulin, Breakthrough T1D has identified several programs that can help. Check them out here.

Agency Funding and Healthcare Principles

Breakthrough T1D is the largest non-governmental funder of T1D research, but we can’t do it alone. Funding from the Federal Government is essential in achieving our mission. For years, the National Institutes of Health and U.S. Food & Drug Administration have played a pivotal role in delivering advancements that improve the lives of people with type 1 diabetes. It is crucial that these agencies continue to be funded at a high level.

Breakthrough T1D Advocates stressed the importance of this partnership and how critical this funding is to our continued success in years to come.

Additionally, Breakthrough T1D Advocates reinforced our healthcare principles, which are key to people with T1D having access to affordable insurance that meets the needs of their T1D.

There’s More Work to Do

Breakthrough T1D Government Day reminds us of the significant impact of grassroots advocacy, and the power we have when we speak as one. The legislation and policy that Breakthrough T1D’s advocates championed will make a difference in the fight against T1D–but there is more work to be done, and we you can help.  

You don’t have a travel to Washington D.C. to have your voice heard by Federal lawmakers. Sign up to be an Advocate, and look out for emails and texts from Breakthrough T1D Advocacy containing action alerts and simple ways for you to get involved and make a difference.

Today, Eli Lilly and Company announced it will begin selling a generic version of its most commonly prescribed insulin — Humalog® — for half the name-brand’s cost. The lower-priced version will be called Insulin Lispro.

What This Means for People with Type 1 Diabetes

While this is an important step forward, we know more must be done.

Breakthrough T1D will keep fighting until insulin is accessible and affordable to everyone who needs it. This week, Breakthrough T1D volunteers will head to Capitol Hill to meet with over 400 members of Congress to advocate for insulin affordability.  In the weeks and months ahead, we will continue to urge drug companies, health plans, employers and the government to take immediate actions to lower the price of insulin and cover insulin as the life-saving drug that it is.

Breakthrough T1D has called for an end to the drug rebate system, which drives up the list price of insulin and reduces choice. Several large health plans already have agreed to share rebates with people with diabetes, and in January, the government proposed ending the use of rebates in federally funded health programs.

Stay tuned for updates and read more here on the principles we will continue advocating to ensure that insulin is affordable and critical innovation continues.

Breakthrough T1D has an online resource with information about available help for insulin and diabetes prescription costs.