Mary Tyler Moore would have been proud to have an award recognizing women who have made pioneering contributions to the fight against type 1 diabetes (T1D). Now, such an award exists!

Presented by Breakthrough T1D, the new award honors the legacy of trailblazer and cultural icon Mary Tyler Moore, who was diagnosed with T1D at the age of 33. As international chairman of Breakthrough T1D from 1984 to 2017, Moore used her influence to bring government, scientists, and people living with diabetes together to further T1D advocacy and innovation.

The award highlights the leadership of women who, like Mary, question the status quo, bravely take risks, and drive changes to improve the lives of those living with T1D.

The inaugural award goes to some of the most powerful women in the United States government who are fighting T1D: Senator Susan Collins (R-ME), Senator Jeanne Shaheen (D-NH), and Representative Diana DeGette (D-CO). Each has provided exemplary leadership, demonstrated the strongest allyship to the T1D community, and has championed and passed legislation that will improve the lives of those living with T1D. These include the Special Diabetes Program (SDP)—which funds $150 million to diabetes research per year—and insulin affordability, including a cap on the price of insulin at $35 per month for Medicare enrollees.

“When most of the world thinks of Mary, they immediately picture Laurie Petrie from ‘The Dick Van Dyke Show’ or Mary Richards from the ‘Mary Tyler Moore Show’ — or many of the numerous other roles she played,” said S. Robert Levine, M.D., her husband of more than 30 years and longtime leading Breakthrough T1D volunteer. “But the biggest role she took on was her profoundly effective advocacy for support for federal funding of research to find cures for T1D and its complications, and her commitment to the T1D community.”  

“I am truly touched that the inaugural award in her name celebrates three government leaders—Susan Collins, Jeanne Shaheen, and Diana DeGette—who partnered with Mary to assure more federal funding of T1D research, including the funding of critical research resources, consortia, and clinical trial networks to bring us closer to cures,” Dr. Levine added.

One of Moore’s most significant achievements as Breakthrough T1D international chairman was increased Congressional funding for the Special Diabetes Program (SDP) at the National Institutes of Health that has accelerated the pace of T1D research. This long-term investment in diabetes research has helped lead to significant scientific breakthroughs, including Tzield™ (teplizumab-mzwv), the first disease-modifying treatment for T1D which can delay the onset of the disease by more than two years.

“Thanks to the enduring efforts of Mary Tyler Moore, we are bringing new treatments forward and moving closer every day to cures for type 1 diabetes and its complications,” said Cynthia Rice, Breakthrough T1D’s chief mission strategy officer. “Senators Collins and Shaheen and Representative DeGette have been steadfast allies in Congress to the T1D community. Breakthrough T1D is proud to recognize their work as they carry Mary Tyler Moore’s legacy forward.”

Natalie Stanback isn’t new to fighting for the type 1 diabetes community. In 2019, she came to Washington DC with her daughter, Nadia to bring awareness to the importance of federal funding for T1D research. Last year, she briefed Congress on the real-world impact of the insulin affordability crisis.

That’s why she’s the perfect person to serve as Chair at the Breakthrough T1D 2023 Children’s Congress. She knows T1D; she knows Advocacy—and she knows how to get things done on Capitol Hill!

Along with her daughter, Nadia, who was a Breakthrough T1D 2019 Children’s Congress Delegate, and her husband, Isaiah, a former NFL wide receiver, Natalie will lead 165 Delegates from all 50 states, along with 5 countries, to tell Congress what it’s like to live with T1D, and what they need to do to help.

“I am so excited to be Chair of Breakthrough T1D 2023 Children’s Congress!” Natalie said. “Last time, we were awestruck by the event. We can’t wait to come back to Washington and continue this important work with all the Delegates.”

When Nadia was diagnosed with T1D at the age of 3, the diagnosis did not come out of the blue. Natalie’s brother, Michael, had been diagnosed 24 years prior. “Given my prior knowledge and experience, Nadia’s diagnosis was breathtaking but not as traumatic as it could have been,” Natalie said. Thankfully, Nadia is doing great. She’s active in sports and she is very involved in the daily management of her T1D.

Natalie still raves about Breakthrough T1D 2019 Children’s Congress. Seeing the impact and feeling the power firsthand is the main reason they are coming back to chair the event.

“It was the best whirlwind that we’ll forever remember,” Natalie said. “We loved the panels, the information and the ability to DO something,” she continued. “It was such a tangible validation and inspiration. I hope that such is the experience and take-away for all of the families and Delegates.”

Breakthrough T1D Children’s Congress is one of the most important things Breakthrough T1D does. Founded in 1999, this event is one of the key drivers that advances Breakthrough T1D’s Advocacy agenda. This event typically happens every other year, but it was canceled in 2021 due to COVID-19. Natalie and the Delegates are ready to make up for lost time!

This year, the focus will be on the Special Diabetes Program (SDP). This program currently provides $150 million annually to T1D research through the National Institutes of Health, the country’s premier medical research agency. The SDP also complements Breakthrough T1D’s research efforts, allowing Breakthrough T1D and the NIH to collaborate to advance T1D research as quickly as possible. This program is set to expire in September and renewing it is Breakthrough T1D’s biggest priority—and the #1 job for the Delegates.

“The SDP is vital,” said Natalie. “By spreading awareness in the halls of Congress and meeting with our lawmakers, we can ensure the research made possible by this program continues. We will make sure the needs of the T1D community are heard loud and clear!”

The Delegates will also speak to the rest of Breakthrough T1D’s advocacy agenda, which includes our efforts around insulin affordability.

“I am looking forward to encouraging other parents to hold on to hope, to count their blessings and to seek the silver linings in this journey,” Natalie said. “That their voices and efforts are meaningful and greatly impact Breakthrough T1D’s progress and footprint. It will take all of us. We must keep going.”

Explore the Breakthrough T1D 2023 Children’s Congress website to learn more about the event, the issues, meet the Delegates from each state, and more!

Watch a 2021 video from ABC’s Good Morning America about the Stanback Family.

In January 2022, the National Clinical Care Commission issued its final report to Congress. The finding were just published in Diabetes Care Here’s what they said about diabetes and what it means.

What is the National Clinical Care Commission?

National Clinical Care Commission (the Commission or NCCC) is a commission formed in 2018 to evaluate and provide recommendations to improve federal programs related to complex metabolic or autoimmune diseases that represent a significant disease burden in the United States. This includes type 1 diabetes (T1D). There are many federal programs that touch healthcare, and the charter of this commission was to make specific recommendations on how the federal government can improve their programs to meet the needs of its citizens affected by these diseases.

Ellen Leake, past chair of Breakthrough T1D’s International Board of Directors, served on the NCCC as an appointed representative of Breakthrough T1D and the T1D community.

The final report outlines evidence-based, actionable recommendations to improve federal diabetes awareness, prevention, and treatment programs; the first guidance like this since 1975. It also calls on the government to improve access to care, address social determinants of health, and improve collaboration between different federal agencies.

What Were Their Recommendations?

The NCCC issued its final report to Congress in January 2022. It included several recommendations around diabetes. These recommendations happen to align with Breakthrough T1D’s Advocacy Agenda!

Here are some, but not all, of the specifics.

Renew the Special Diabetes Program For Longer at a Higher Level

The Special Diabetes Program (SDP) is a critical program that provides $150 million annually for T1D research at the National Institutes of Health (NIH), the country’s premier medical research agency. The SDP complements Breakthrough T1D’s research efforts. Together, they are leading to new insights and therapies that are improving the lives of people with diabetes and accelerating progress to cure, treat, and prevent T1D.

The SDP has provided over $3.4 billion to T1D research since its inception in 1997—and the investment has paid enormous dividends—funding research that has directly led to new therapies for the T1D community.

The SDP is set to expire in September, and much of the funding it has received in recent years has been short-term, sometimes in months-long increments. The NCCC realizes the significance of long-term funding and recommends the program be renewed in five-year increments and include annual increases in funding to at least  account for inflation costs. 

Breakthrough T1D strongly supports this recommendation.

Updates to Centers for Medicare & Medicaid Services

The Centers for Medicare & Medicaid Services (CMS) is the governing body that oversee Medicare and Medicaid, which are federal and state programs that provide health insurance and help with costs to millions of Americans. The NCC had specific recommendations for CMS, including update and regularly (at least every three years) evaluate eligibility requirements for various diabetes devices leading to appropriate coverage determinations. This is important because the landscape of T1D tech is rapidly changing; state of the art today may not be state of the art in three years. This recommendation ensures that the diabetes community will have access to the best tools and therapies. It also recommends that CMS consider patient-reported outcomes into their calculus—which is incredibly important and brings user-feedback into the process.

This recommendation is heartily welcomed by Breakthrough T1D. Breakthrough T1D led the fight to have Medicare cover CGM technology—and it took years for this vulnerable population to have access to lifesaving CGMs. This recommendation ensures that the current landscape is regularly evaluated.

Increasing Access to Improve Outcomes

Access to insulin and therapies like insulin pumps and CGMs can be a challenge in America. Insulin affordability is a crisis—even with the recent steps taken to put a cap on the cost of insulin for those on Medicare. For that reason, Breakthrough T1D is encouraged by two recommendations by the NCCC around cost and access.

One recommendation is that federal policies and programs remove cost barriers to ensure that insulin is affordable for all people with diabetes and that no one with diabetes who needs insulin cannot get it because of cost. Breakthrough T1D hopes Congress takes this recommendation seriously and works to address the issue.

Another is that the US Department of Health and Human Services (HHS) establish a process to determine and regularly reevaluate high-value diabetes services and treatments to be fully covered (pre-deductible) by health insurance based on their ability to prevent development or progression of diabetes complications. As therapies have improved, so have their abilities to keep individuals with T1D in range more of the time, which leads to fewer complications. Breakthrough T1D supports this as well.

What Happens Now?           

The NCCC’s work is officially done. Their report was delivered to Congress, and it is up to Congress to take these recommendations and implement them as they see fit. Breakthrough T1D has and will continue to share our strong support for these recommendations with Congress as part of our ongoing advocacy efforts to improve the lives of those with T1D and accelerate research to cure, treat and prevent T1D.

Breakthrough T1D is honored to have been involved in the Commission’s work through Ellen and we thank her for her continued commitment to advance research and care for those living with T1D. Breakthrough T1D also thanks the whole NCCC for their hard work and for making recommendations that will improve the lives of the diabetes community in the US.

One of Breakthrough T1D’s top legislative priorities has been achieved with the enactment of a three-year renewal of the Special Diabetes Program (SDP). The program, now funded until September 30, 2023 at $150 million per year, will enable researchers to build upon the momentum in type 1 diabetes (T1D) to date and explore new opportunities that have been waiting for funding. Throughout the course of 2020, the SDP received intermittent funding while Congress worked on a longer-term renewal of the program. This is a huge win for, and one that we share with, the entire T1D community and their loved ones and is the longest renewal of funding since 2004.  

This wonderful news became a reality due to the tireless commitment of our Breakthrough T1D volunteers and advocates through Breakthrough T1D’s mobilizations and campaigns, most recently 452 ‘Promise to Remember Me’ virtual meetings between Members of Congress and advocates of all ages and experiences. Our champions in Congress include Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH) and Representatives Diana DeGette (D-CO) and Tom Reed (R-NY) who we’d like to thank for their tremendous leadership and work to secure this and many other renewals.

Enacted in 1997, the SDP helps improve lives by advancing research to treat, prevent and ultimately find cures for T1D through the National Institutes of Health (NIH). The program has helped scientists make significant advances – including artificial pancreas technology, beta cell replacement techniques, improvements to continuous glucose monitors and treatments for complications of T1D like diabetic retinopathy.

Research was the key to the discovery of insulin 100 years ago – prior to this breakthrough, people typically survived two years or less with T1D.  Research is also the key to tomorrow’s prevention and cures, and to improving lives now and in the future. The SDP complements many of Breakthrough T1D’s research priorities but also helps the T1D community as it supports research in cures as well as improving lives. 

Join us in saying ‘Thank You’ to Congress today and if you’re interested in becoming a Breakthrough T1D advocate, sign up here!

Cass Freeland of Columbus, Ohio, knows how to connect with policy makers.

“People of power remember your personal stories,” she said. “Advocacy is about relationships, telling stories and coming together for group action.”

Freeland, whose son has T1D, speaks from experience. She’s a former lobbyist who has worked for organizations such as the Ohio Education Association.

Given her professional background, it came as no surprise that Freeland, who started volunteering for Cass Freeland and Rep. Joyce Beatty Breakthrough T1D shortly after her son was diagnosed in 2016, was tapped to head up the Central Ohio Chapter’s advocacy efforts.

Today, Cass Freeland leads the Central Ohio Chapter’s advocacy efforts, including organizing the Promise Meetings. She has visited Capitol Hill twice to advocate on behalf of Breakthrough T1D.

“People living with T1D have great tools that make managing their T1D much easier,” Freeland said. “How did we get those things? Yes, because of research and development, but also because families and people living with T1D demanded them.”

During Freeland’s visits to DC, she has met with several Members of Congress—including U.S. Representatives Joyce Beatty (D-OH-3rd) and Steve Stivers (R-OH-15th)—to advocate for continued Cass Freeland and Rep. Steve StiversFederal research funding for T1D, and legislation and policies that support affordability, choice, and coverage of T1D management tools.

“These Members are willing to consider and support my asks on the spot because they remember that I had previously come to see them with my son and other advocates,” she said. 

She also secured meetings with three of four Northeast Ohio congressional offices. All signed a letter supporting funding for the Special Diabetes Program.

“This is a way for me to use my skills to give back,” she said.

Learn more about our advocacy agenda and find out how you can become a Breakthrough T1D advocate! 

This week, the Food and Drug Administration (FDA) approved the Medtronic MiniMed 770G artificial pancreas system for use by children aged 2 to 6 with type 1 diabetes (T1D). The 770G System is now approved for ages 2 and older and is the first marketed device that can automatically adjust insulin delivery based on continuous glucose monitoring (CGM) values for children aged 2-6 years.

The Medtronic MiniMed 770G is a Bluetooth-enabled version of the previously approved MiniMed 670G System, which will enable sharing of data on smart devices. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime. (This device is not approved for use in children younger than 2 years old and in individuals who require less than eight units of insulin per day.)

The FDA evaluated data from a clinical trial that included 46 children aged 2 to 6 years old with T1D.  The study found no serious adverse events, and data from the study was used to help support the expanded indication for people 2 to 6 years old.

Breakthrough T1D Impact

Breakthrough T1D has been a leader in the development of artificial pancreas systems for 15 years, since starting the Breakthrough T1D Artificial Pancreas Project in 2005 and the Breakthrough T1D Artificial Pancreas Consortium, which have dramatically accelerated progress by bringing academic researchers, government agencies, industry and the Helmsley Charitable Trust together to pursue artificial pancreas technology.

Through these efforts, Breakthrough T1D developed a roadmap for artificial pancreas development with increasingly advanced versions of the device. Manufacturers embraced the roadmap to guide their own research and development programs. Breakthrough T1D has also worked with Congressional leadership—particularly Senate Diabetes Caucus Co-Chairs Susan Collins of Maine and Jeanne Shaheen of New Hampshire and Congressional Diabetes Caucus Co-Chairs Diana DeGette of Colorado and Tom Reed of New York—to secure Federal funding through the Special Diabetes Program (SDP) for artificial pancreas research and overcome obstacles that could delay delivery of artificial pancreas systems to people with T1D.

The Special Diabetes Program (SDP) is up for renewal, so if you haven’t done so already, please sign-up to be an advocate, and encourage friends and family to do the same.

This is the latest example of how Breakthrough T1D research and advocacy work together to make T1D management better and safer. This is a win for the T1D community, and provides people at a young age with T1D another option to improve blood sugar daily management, until cures are found.

On June 17, Tandem Diabetes announced FDA clearance of an expanded pediatric indication for the Tandem t:slim X2™ insulin pump with Control-IQ™ technology in children ages six and older. This device was initially only authorized for use in people 14 and older. Simply put: more people now have access to this life-changing technology.

“Today’s clearance by the U.S. Food and Drug Administration (FDA) extending the pediatric indication of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology is another big win for the T1D community and especially for our youngest members,” said Sanjoy Dutta, Ph.D., Breakthrough T1D Vice President, Research. “With this technology now available to children ages six and above, families have an additional option to explore as they seek to find the system that best suits their needs.”

The data for the clearance came from the International Diabetes Closed Loop Protocol-5 (DCLP5), a six-month study of children ages 6-13. This study was funded by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) with funds from the Special Diabetes Program (SDP), for which Breakthrough T1D is the primary advocate. The results are definitive: Control-IQ™ helps children with T1D do better.

Per Tandem’s announcement, children in the six-month trial experienced:

Control-IQ™ first received FDA authorization for people 14 and older on December 13, 2019. Critically, at the time, it became the first algorithm authorized as an interoperable automated glycemic controller, meaning the algorithm could be a component of an open protocol, or interoperable, artificial pancreas system.

Breakthrough T1D has been a leader in the development of artificial pancreas systems since starting the Artificial Pancreas Project over 15 years ago. Through years of research funding, collaboration with regulatory agencies and leadership in the field, Breakthrough T1D has helped accelerate the development of transformative therapies that make life better for people living with T1D. Breakthrough T1D has also been a leading advocate for coverage, affordability and choice for diabetes technology and the insulin people need through our Coverage2Control campaign. People with T1D need options, which is why Breakthrough T1D continues to call upon United Healthcare to lift its restrictions on insulin pump coverage, and cover all FDA authorized devices.

Today is a big win for the T1D community that will help a lot of children (and their parents!) sleep better at night.

On March 27, 2020, Congress passed the Federal economic relief package, also known as the CARES Act (Coronavirus Aid, Relief, and Economic Security). This legislation supports non-profit organizations during the unprecedented environment caused by the coronavirus pandemic and these difficult economic times. Targeted measures include the expansion of Charitable Giving Incentives for both individuals and corporations and providing additional tax relief for taxpayers who support charities.  

As a non-profit organization, Breakthrough T1D depends on donations from our generous supporters to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes (T1D) and its complications. Although this news emerges out of the current crisis, it provides our donors with the wonderful incentive to support the Breakthrough T1D community, and ensures our progress continues.  

Learn how these new tax policy changes may affect you by reviewing our answers to commonly asked questions below.   

What is the Charitable Giving Incentive?

The Charitable Giving Incentive is a new, above-the-line deduction available to taxpayers who do not itemize their deductions in annual charitable contributions of up to $300. This applies to cash contributions made in 2020 and can be claimed on 2020 Form 1040 when filing in 2021. 

Note, this incentive does not apply to contributions to donor advised funds, private non-operating foundations, or section 509(a)(3) supporting organizations. All other contributions for which a deduction is allowable under section 170 are covered.

What if I itemize my deductions?

Cash contributions are 100% deductible. The contribution limits are increased for those who itemize their deductions. The current limits for cash contributions of 60 percent of adjusted gross income have been suspended for contributions made in 2020. 

Note, this does not apply to contributions made to donor-advised funds, private non-operating foundations, or section 509(a)(3) supporting organizations. 

What does this mean for corporations? 

The limit on charitable deductions for cash contributions in 2020 is increased from 10 percent to 25 percent for corporations. Also, the limit on deductions for food donations in 2020 are increased from 15 percent to 25 percent. 

Where can I find more information about this? 

The provisions specific to the Charitable Giving Incentive can be found in the CARES Act, Sections 2204-2205. If you have specific questions and need support filling out your tax forms, please contact your tax advisor. To find out more about ways to give to Breakthrough T1D, please visit breakthrought1d.org/ways-to-give/

How else was the T1D community supported in the CARES Act? 

This relief package, which was approved by both the House and Senate and signed by the President on March 27, 2020, included three additional benefits for the T1D community. The package: 

Countless have been working diligently for months alongside Breakthrough T1D staff and with our champions in Congress to achieve these benefits. You can read more about this progress here.

Thank you for your ongoing support of Breakthrough T1D. Together, we will realize our vision of a world without T1D.  

The Federal Government has continued its commitment to support diabetes research by providing more than $75 million into the Special Diabetes Program (SDP), which drives forward critical research aimed at curing type 1 diabetes (T1D) and improving the lives of those living with the disease today.

The funding, approved by both the House and Senate and signed by the President, extends support for SDP until November 30, 2020. Renewing the SDP is one of Breakthrough T1D’s top legislative priorities, and countless Breakthrough T1D advocates have been working diligently for months alongside Breakthrough T1D staff and with our champions in Congress to achieve this milestone.

Funding through the SDP, which is administered by the National Institutes of Health, complements and expands research driven by Breakthrough T1D. By leveraging Federal dollars, funding from partners and supporter donations, Breakthrough T1D accelerates the race to cure type 1 diabetes and supports everyone living with the disease today.

“We are grateful to Congress and the Administration for continuing to acknowledge and support the critical need to cure T1D, which impacts an increasing number of families every year. We look forward to continuing work to further support the T1D community, including ensuring everyone can access affordable insulin, an especially urgent concern in this economic climate,” said Aaron, J. Kowalski, Ph.D., Breakthrough T1D President and CEO.

This is the fourth Special Diabetes Program extension passed by Congress since September. This extension was included in the Federal economic relief package created in response to the coronavirus pandemic.

The package also included two additional benefits for the T1D community:

For additional resources aimed at supporting access and payment for insulin and other prescriptions visit our Health Insurance Guide.

What would intimidate even the most seasoned speakers had little impact on the three teens who met with the Food and Drug Administration (FDA) on behalf of Breakthrough T1D and the type one diabetes (T1D) community.

The teens have already been through so much. Sharing their stories of living with T1D, they said, is easy in comparison.

“Having something you can’t control hold you back is pretty miserable,” said Hayden Kirk, 16, of Atlanta. “But when you talk about advances and work happening for a cure, that’s nice—that’s when you see hope in everyone’s eyes.”

Hayden and two other youth delegates attending Breakthrough T1D Children’s Congress 2019 thanked members of the FDA for reviewing and approving both clinical trials and new therapies for T1D.

“Each of these delegates has been personally touched by the work you do here,” Breakthrough T1D CEO and President Aaron J. Kowalski, Ph.D., told the panel. “We are here to thank you for your support.”

Breakthrough T1D frequently meets with the FDA to share the impact that key advances FDA is reviewing can have on the T1D community, explain the complexities of the disease and the need for innovation to improve lives today while research aims for cures for tomorrow.

Hayden Kirk shared with the FDA staff his experience of participating in a clinical trial of an artificial pancreas system and of using the new technology now on a daily basis.

“The new technology makes my life a whole lot easier, especially when doing sports,” Hayden shared.

Elizabeth Link, 16, of Inver Grove Heights, Minnesota, told the group that she agreed to participate in a two-year clinical study of an immune therapy when she was newly diagnosed because she knows that the studies are critical to advancing science and finding cures.

“Participating in the study gives me hope that cures are in the near future,” Elizabeth said.

Sam Southwick, 16, of Sioux Falls, South Dakota, talked about the struggles of managing T1D while still pushing to be an athlete, student and teenager, and also participating in a clinical trial that used his own cells to try to preserve the function of insulin-producing beta cells.

“I want to do my part by participating in research to help myself and others. I don’t want to live with this disease forever,” Sam said.

Breakthrough T1D hosts Children’s Congress every two years, bringing youth delegates and celebrity role models from all over the country and world to advocate for Congressional support for T1D research and support. This year, the ask is for Congress to renew the Special Diabetes Program, which funds $150 million in research each year, while also thanking officials like those at the FDA for their work in advancing critical research and approving innovative therapies.

Take a minute to hear two of the delegate’s stories through their own videos.

https://www.youtube.com/watch?v=G4lUsXEBoC8