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.

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)

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) 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. Left-click on image to slightly enlarge.

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.”

As reported in Harvard Business Review, “Research has shown that firms with more women in senior positions are more profitable, more socially responsible, and provide safer, higher-quality customer experiences—among many other benefits.”  

It should be no surprise then that Breakthrough T1D, the leading global nonprofit funding type 1 diabetes (T1D) research, has promoted two more women on its executive leadership team: Kathleen Seitz and Sydney Yovic. 

Breakthrough T1D has ambitious but strategic goals to further amplify its role as a global leader in the T1D space. Promoting both high performing, innovative-thinking women to more senior leadership roles maps directly to those goals. 

Kathleen Seitz 

Breakthrough T1D is pleased to announce that Kathleen Seitz, Senior Vice President, Global Development, has been promoted to Chief Global Development Officer overseeing the field network, volunteer engagement and all contributed revenue sources. 

With more than 25 years of development experience, Kathleen has worked with a cross-section of nonprofits, including cultural, healthcare, human service, secondary and higher education, and religious organizations. She has significant expertise in volunteer management, fundraising staff recruitment and training, and strategic fundraising planning. Kathleen also received her Certified Fundraising Executive (CFRE) designation in 2019.  

In her short time with Breakthrough T1D, Kathleen has already made an immediate impact, growing and guiding her team so they are well-positioned to maximize our revenue and build a global development strategy to increase Breakthrough T1D’s global footprint and presence. 

As Chief Global Development Officer, Kathleen will lead Breakthrough T1D’s efforts to maximize initiatives and raise more funds to advance our mission in the United States and globally. We look forward to the positive impact Kathleen will continue to have on Breakthrough T1D and the T1D community as she drives continual improvement of fundraising strategies and engagement in Breakthrough T1D programs. 

 Sydney Yovic 

Breakthrough T1D is pleased to announce that Sydney Yovic, Chief of Staff, has been promoted to the position of Chief Strategy Officer and Chief of Staff. 

Sydney has been a valuable, results-driven leader for Breakthrough T1D for over 10 years, having started as Project Manager in the Research department and taken on roles of increasing responsibility since then. She continues to be an incredibly valuable partner to staff and volunteers throughout the organization.  

In her newly expanded role, Sydney will lead and drive Breakthrough T1D’s strategy and organizational priorities to help shape our future vision and propel our mission forward. Sydney will continue to be a tremendous asset as she develops strategic plans, implements impact measures, and centralizes resources to ensure Breakthrough T1D is operating at the highest levels of effectiveness and efficiency. 

Breakthrough T1D and the T1D community will continue to benefit from Sydney’s strong leadership skills as she works to ensure Breakthrough T1D’s organizational strategies, processes, tools, systems and offerings are well-positioned to drive continual improvement, growth, and impact. 

The Association of Diabetes Care & Education Specialists (ADCES) goal is to improve diabetes outcomes through innovative education, management, and support, and it has over 12,000 members. Each year, they give out a number of awards. These are a big deal. And, this year, the 2023 Diabetes Care and Education Specialist of the Year Award is going to <drumroll please> Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, JDRF’s director of community screening and clinical trials education!

The award recognizes a diabetes specialist who has made a special contribution through dedication and innovation in the daily practice of patient care. And, oh, has Anastasia made a profound contribution! Let’s take a look:

• She has been actively involved in diabetes care, education, advocacy, and research—including being a Breakthrough T1D volunteer for the past two decades—since 2002, when her daughter was diagnosed with type 1
• Anastasia is a licensed and board-certified pediatric nurse practitioner, certified diabetes care and education specialist, and certified to train people with diabetes on how to use insulin pumps, continuous glucose monitors (CGMs), and automated insulin delivery systems (also known as artificial pancreas systems)
• She has been an avid diabetes advocate since 2002 and has spoken at congressional hearings, the White House, and in the Florida legislature
• She served as co-chair for the American Diabetes Association’s Safe at School Working Group, and was a co-author for guidelines related to diabetes management in the school setting
• Anastasia recently founded a Florida-based nonprofit, Diabetes Toolkit, designed to support the diabetes education provided in clinic

And I could go on and on…but I won’t. (But she’s got a resumé that would make anyone’s head swirl!)

The award was given to her at the ADCES Annual Conference on August 12-15, 2022. The award also provides a cash prize and a commemorative plaque.

Please applaud Anastasia on her congratulatory and well-deserved honor!

Jennifer Bennett, managing director and associate general counsel in the Office of the Corporate Secretary for Bank of America Corporation in Charlotte, North Carolina, has been appointed Chair of the Breakthrough T1D Global Mission Board (GMB), effective July 1, 2022.

The Breakthrough T1D GMB also welcomes new members Meredith Coors (Mountain West Chapter), Laura Cramer (Mid-Atlantic Chapter), Maarten de Groot (Breakthrough T1D Netherlands), Gwen Malone (Pacific Northwest Chapter) and David Schwab (Mid-Atlantic Chapter), to help drive mission progress through volunteer engagement.

The Breakthrough T1D GMB, created in 2019, is a group of volunteer leaders who collaborate with staff leaders to advance Breakthrough T1D’s mission through special initiatives in research, advocacy, fundraising, and community engagement. Jennifer will be the second-ever Chair of the GMB, following Kim Roosevelt, who served in the role for the last three years.

Vanguard Volunteer

Jennifer became part of Breakthrough T1D 17 years ago when her child, Rain, was diagnosed with type 1 diabetes (T1D) at the age of three. Her family has participated in the Breakthrough T1D One Walk every year since Rain’s diagnosis.

Jennifer’s dedication to Breakthrough T1D is unmistakable. Jennifer has volunteered in many roles in Breakthrough T1D’s North Carolina Chapter, including as Chapter Board President and Executive Council Chair. At the national level, she previously served on the International Board of Directors (IBOD) and is currently on the IBOD’s Nominating and Governance Committee and the Talent and Compensation Committee. She has been a member of the GMB’s leadership since 2019, heading the fundraising and engagement pillar.

“Our Global Mission Board plays a critical role in Breakthrough T1D’s Mission and in recruiting and engaging volunteers,” said Aaron J. Kowalski, Ph.D., Breakthrough T1D Chief Executive Officer. “I’m confident that our GMB, together with Jennifer and its newest board members, will harness the passion of our volunteers to accelerate our mission progress and move us even closer to a world without T1D.”

Steve Davis was a leader in the restaurant and consumer packaged goods industries, but to Breakthrough T1D, he was a beloved member of the Breakthrough T1D family and our International Board of Directors. It is with incredible sadness and heavy hearts that we share that Steve passed away of sudden cardiac arrest on July 10, 2022.

We are forever grateful for Steve’s many years of service to Breakthrough T1D, as well as the time, talent, and support he generously dedicated to changing the world for people living with T1D.  Steve and his wife, Lynnda, got involved with Breakthrough T1D’s Central Ohio chapter when their daughter was diagnosed with T1D in 2009. Since then, they worked tirelessly to accelerate Breakthrough T1D’s mission, fund critical research, and drive life-changing breakthroughs to cure, prevent, and treat T1D.

Steve served as CEO of Bob Evans from 2006 – 2015 and during that time, he and Lynnda were instrumental in promoting and partnering with Breakthrough T1D through store campaigns, community fundraisers, and Walk Sponsorships. In addition, Steve’s legacy of impactful contributions includes:

• Steve and Lynnda have both served on the Central Ohio Breakthrough T1D Board of Directors.
• Steve served as Corporate Recruitment Chair for the 2013 and 2014 Walk to Cure Diabetes (OneWalk)
• In support of the 2014 Walk to Cure Diabetes, Steve held a National Sneaker Sale through Bob Evans that raised over $103,000 for Breakthrough T1D nationwide.
• In 2015, Steve and Lynnda were Gala Honorees and received the Breakthrough T1D Buckeye Promise Award for their dedication to Breakthrough T1D and the community.

Steve served on Breakthrough T1D’s International Board of Directors since 2017, was a member of the Funding Committee, and most recently served as the Nominating and Governance Committee Chair for the last three years.

Steve was a true T1D champion and changemaker. The impact of his philanthropic efforts will benefit the T1D community for years to come and we are grateful for the role he played in bringing us closer to curing T1D than we’ve ever been. 

Please keep Lynnda, their three daughters Brittany, Stephanie and Cassie, and the entire Davis family in your thoughts and prayers during this incredibly difficult time. 

Grant Beard, Executive Operating Partner, LP, and Co-investor at Blue Point Capital Partners, will serve as Breakthrough T1D International Board of Directors (IBOD) Chair, succeeding current Chair Joseph (Joe) P. Lacher. Michelle Griffin, a management consultant with more than 25 years of experience, will serve as Breakthrough T1D IBOD Vice Chair, succeeding current Vice Chair Lisa Fishbone Wallack. 

Grant Beard: Supporting Breakthrough T1D’s Research Mission

Grant and his wife Susan have been volunteer leaders since their daughter Emily’s T1D diagnosis in 2006 at age 14. They were recognized for their support of T1D research and research related education with the 2016 Jane Jospey Cobb Promise Award.

Grant has served eight years on the IBOD and sits on the Breakthrough T1D T1D Fund Board of Directors. As part of the IBOD, he chairs the Audit & Risk Committee and is a member of the Funding Committee. Grant previously served as the President of  the Board of Directors for Breakthrough T1D’s Metro Detroit/Southeast Michigan Chapter (now the Michigan and Northern Ohio Chapter). 

“Working with my colleagues on Breakthrough T1D’s International Board of Directors to drive mission impact has been a deep honor for me,” Grant said. “Michelle and I, in partnership with our fellow Breakthrough T1D leaders, will continue to move our mission forward. Today, given where the science is, we have an unprecedented opportunity to make a difference in the lives of those living with T1D–here and around the world.” 

Michelle Griffin: Supporting T1D Families

Michelle’s son Cameron was diagnosed with T1D in 2007 at age nine and she and her husband, Tom Parker, have been actively involved with Breakthrough T1D since. 

Michelle served on the IBOD for six years and was Chair of the Development and Audit Committees. She is currently a member of Breakthrough T1D’s Global Mission Board and Audit Committee and is a Special Advisor to the Funding Committee. She has worked in a variety of roles for Breakthrough T1D’s Northern California Chapter, presently as Co-Chair of Leadership Giving. In 2017, Michelle received the Jim Tyree Chairman’s Choice Award for her noteworthy volunteer contributions to Breakthrough T1D. 

“I have been a Breakthrough T1D true believer ever since our son Cameron participated in a Breakthrough T1D funded clinical trial two months after diagnosis in 2007,” Michelle said. “It is an incredible honor to be asked to serve as Vice Chair, especially at this time when we are seeing the fruits of the Breakthrough T1D community’s longtime support of our mission to accelerate life-changing breakthroughs. I am very excited to partner with Grant, our talented staff, and passionate volunteers to keep the momentum going as we get ever closer to making cures a reality.” 

This new leadership is a positive evolution for Breakthrough T1D, which has recently seen a number of exciting research breakthroughs. 

“In the past few months alone, we have seen incredible progress in cures research—most notably in cell therapies,” said Aaron J. Kowalski, Ph.D., Breakthrough T1D Chief Executive Officer. “Having Grant and Michelle step into these leadership roles ensures we will continue to drive our mission forward globally through scientific advancements and advocacy.” 

“We thank Joe and Lisa, who began their leadership in the early months of the pandemic, which upended our fundraising model. Under their direction, Breakthrough T1D devised strategic priorities to advance more therapies, raise more funds, and activate more volunteers,” Kowalski added. “We welcome Grant and Michelle, and look forward to partnering with them to amplify our impact as we improve lives around the world and move closer to curing T1D. It is truly an exciting time to be at Breakthrough T1D.”  

About the Breakthrough T1D International Board of Directors (IBOD) 

IBOD is the governing body for Breakthrough T1D and is tasked with accelerating the organization’s mission progress toward life-changing breakthroughs to cure, prevent, and treat type 1 diabetes and its complications. Learn more about Breakthrough T1D’s volunteer and staff leadership. 

During our 50+ years of advancing diabetes research, Breakthrough T1D has funded the best and the brightest investigators. But which of them have contributed the most to what we know about type 1 diabetes (T1D) today? In honor of the 100th anniversary of the first administration of insulin, Breakthrough T1D is launching “100 Years, 100 Breakthrough T1D Scientists,” the story of the scientists who contributed to discoveries that played a part in the vast knowledge that we have about diabetes today.

The first up: Gian Franco Bottazzo, M.D. Born in Venice, he obtained his M.D. degree in 1971 at the University of Padua. Shortly after, he began a research fellowship with immunologist Deborah Doniach, M.D., at Middlesex Hospital, and, in 1998, he returned to Rome. He died in 2017.

Aha! An Autoimmune Disease!

When Breakthrough T1D was founded, there were no types of diabetes. There was no type 1, no type 2. It was all diabetes.

But, early on in Bottazzo’s fellowship, in 1974, he discovered—for the first time—that diabetes is associated with the development of islet cell antibodies (ICA), leading to a landmark publication in the field.¹ This was instrumental in establishing type 1 diabetes (T1D) as an autoimmune disease.

The discovery of ICA introduced a new era of diabetes research and understanding:

Gian Franco Bottazzo, M.D.

1. A chronic disease: Together with Andrew Cudworth, M.B., and funded with a Breakthrough T1D grant, Dr. Bottazzo measured ICA in samples from relatives of individuals with T1D. In 1981, they reported that ICA was detectable years before the clinical onset of disease,² a finding that eventually led to the notion that T1D was a chronic disease.

2. Before clinical symptoms: Moreover, ICA were shown to have value in identifying individuals who would later develop T1D, providing new staging for presymptomatic T1D. It also enabled the discovery of more antibodies that were associated with T1D. There are now five antibodies—ICA, GAD65, IAA, IA-2, and ZnT8—connected with the disease. The presence of two or more means that your lifetime risk of getting T1D is nearly 100 percent. Dr. Bottazzo’s research contributed to a number of studies about the genetic risk of developing T1D.^3,4

3. Refine the tests for T1D-related antibodies: These were quantified by Breakthrough T1D units,”^5,6 a measure of the number of T1D-specific antibodies that were detected in a person. This led to the formation of a number of clinical studies to determine the risk of T1D—DAISY, ASK, and TrialNet in the United States, BABYDIAB in Germany, DIPP in Finland, and DiPiS in Sweden.

More recently, Breakthrough T1D initiated T1Detect, an education and awareness program to expand screening to the general population. The program’s aim is to make people understand what type 1 is, how screening is advantageous to the public, how they can be involved, and what to do if you are positive for T1D-specific antibodies.

4. Conduct clinical trials: It also enabled clinical trials aimed at delaying the clinical onset of diabetes, before symptoms appear. This includes teplizumab—a drug that blocks CD3, a blood marker that helps activate immune cells. It was the first study to significantly delay the onset of T1D, for nearly 3 years, in individuals at-risk of developing the disease.

I hope you enjoyed reading about a T1D champion. Follow up each week to find out who we selected and their major discoveries, in honor of the 100th anniversary of the first administration of insulin.

Research is how insulin was discovered as a therapy for diabetes, and Breakthrough T1D research is advancing us toward cures and the next generation of life-changing breakthroughs for T1D.

1. Bottazzo GF, Florin-Christensen A, Doniach D. Islet-cell antibodies in diabetes mellitus with autoimmune polyendocrine deficiencies. Lancet. 1974 Nov 30; 2 (7892): 1279-83. PMID: 4139522.
2. Gorsuch AN, Spencer KM, Lister J, McNally JM, Dean BM, Bottazzo GF, Cudworth AG. Evidence for a long prediabetic period in type I (insulin-dependent) diabetes mellitus. Lancet. 1981 Dec 19-26; 2: 1363-1365. doi: 10.1016/S0140-6736(81)92795-1. PMID: 6118756.
3. Bottazzo GF, Pujol-Borrell R, Hanafusa T, Feldmann M. Role of aberrant HLA-DR expression and antigen presentation in induction of endocrine autoimmunity. Lancet. 1983 Nov 12; 2 (8359): 1115-1119. doi: 10.1016/S0140-6736(83)90629-3. PMID: 6138647.
4. Bottazzo GF, Dean BM, McNally JM, MacKay EH, Swift PG, Gamble DR. In situ characterization of autoimmune phenomena and expression of HLA molecules in the pancreas in diabetic insulitis. N Engl J Med. 1985 Aug 8; 313 (6): 353-60. doi: 10.1056/NEJM198508083130604. PMID: 3159965.
5. Bonifacio E, Bingley PJ, Shattock M, Bean BM, Dunger D, Gale EA, Bottazzo GF. Quantification of islet-cell antibodies and prediction of insulin-dependent diabetes. Lancet. 1990 Jan 20; 335: 147-149. doi: 10.1016/0140-6736(90)90013-U. PMID: 1967440.
6. Gleichmann H, Bottazzo GF. Progress toward standardization of cytoplasmic islet cell-antibody assay. Diabetes. 1987 May; 36 (5): 578-584. doi: 10.2337/diab.36.5.578. PMID: 2436962.

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 toward creating a world without type 1 diabetes.

1. Accelerating Cures with Stem Cell-Based Therapies

Ninety-one percent less insulin, at half the target dose? Check.
Clinical trial for a gene-edited stem cell replacement therapy? Check.
First reported evidence of implanted stem cells secreting insulin in response to meal consumption? Check.

We’ve got a lot to be thankful for in stem cell therapies.

This year, The New York Times and Good Morning America highlighted the story of Brian Shelton, the first person to receive Vertex’s stem cell-derived therapy, VX-880, showing he needs 91 percent less insulin than before the transplantation. While these are early results from just one person, and this therapy is only being tested in people with severe hypoglycemia, breakthroughs like this bring us a step closer to finding cures for T1D.

Starting in 2000, Breakthrough T1D played a key role in the development of VX-880 by awarding Douglas Melton, Ph.D., a grant to make insulin-producing beta cells from stem cells, which his team did in 2014. Melton founded Semma Therapeutics in 2015, and the Breakthrough T1D T1D Fund made a catalytic investment in 2017. Vertex acquired Semma for almost $1 billion in 2019, and, in March 2021, the FDA fast-tracked its trial of VX-880—producing these exciting results just six months later.

Another big player in the stem cell-derived beta cell space is ViaCyte, who is a longstanding Breakthrough T1D partner and had two announcements. One is for VCTX210, which combines CRISPR Therapeutics’ gene editing technology with ViaCyte’s proprietary stem cell therapy, which will launch a clinical trial in Canada—the first for a gene-edited cell replacement therapy in T1D. The second is preliminary results from its second technology, VC-02™, which yielded the first reported evidence of implanted stem cells secreting insulin in response to meal consumption.

2. Coxsackie Vaccine Has Positive Results

Breakthrough T1D has been funding research into the role viruses play in the development of T1D since the late 1970s and, in the 1990s, we funded a postdoctoral fellowship for Heikki Hyöty, M.D., Ph.D., who demonstrated that enteroviruses—specifically coxsackie B—are the main culprit for T1D. Coxsackie B is a common pathogen where, in most circumstances, the infection is asymptomatic or results in mild symptoms. (Coxsackie B, however, in rare cases, may also lead to viral meningitis, heart or brain infection, or hand, foot, and mouth disease.)

Hyöty co-founded Vactech in 2001, who developed PRV-01, a vaccine targeting coxsackie B, and licensed it to Provention Bio*, which got an investment from the Breakthrough T1D T1D Fund for a first-in-human clinical trial. The results: Not only was it well tolerated, but it induced high concentrations of anti-coxsackie B antibodies.

This was only the interim results; the final results will be revealed this year. But, if they are the same as the interim results, continued development of the vaccine and its use to reduce the burden of T1D will be under way.

*Provention also has teplizumab, the first drug to delay the onset of T1D for nearly three years, under review by the FDA. Breakthrough T1D had a hand in the development of teplizumab from almost the beginning. We 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 animal study, that he could prevent autoimmune diabetes with an anti-CD3 antibody (which, later, became a humanized version, teplizumab). He has gone on to receive more than 15 grants from Breakthrough T1D, and was the lead on the clinical trial that demonstrated that it could delay the onset of T1D for nearly three years.

3. COVID-19 Update

Many of you joined our efforts to raise awareness of the impact that COVID-19 has on the T1D community. This work resulted in the U.S. Centers for Disease Control and Prevention (CDC) updating its guidelines to include T1D on the list of medical conditions associated with higher risk of becoming severely ill from COVID-19. It also helped us secure for members of the T1D community prioritized access to the COVID-19 vaccines and boosters when they first became available.

4. On Medicare? Accessing CGMs Just Got Easier

A regulation by the Centers for Medicare and Medicaid Services (CMS) puts in place expanded access to continuous glucose monitors (CGMs) for people on Medicare. The final rule provides coverage for all FDA authorized CGMs. Previously, CMS only covered therapeutic CGMs, which are those devices approved by the FDA to make insulin dosing decisions (e.g., without use of fingersticks in addition to CGM). This expansion means that people on Medicare with diabetes will now have access to a broader choice of CGMs, similar to what is available to those with commercial insurance.

The positive impact of CGMs on the health and well-being of those with T1D is clear and Breakthrough T1D has long advocated for broader coverage and choice of CGMs, resulting in private plan coverage starting over a decade ago, and Medicare coverage on a partial basis in 2017 and expansion last year. The CMS decision marks an important milestone for Medicare’s coverage of therapies that will improve the lives of those with T1D.

5. Regulatory Approval of Several T1D Therapies and Technologies

We fund research to facilitate the development of new therapies and technologies to make day-to-day life with T1D easier, safer, and healthier, until we can find cures or prevent this disease. In 2021, we got a lot to be thankful for.

Apps

• The FreeStyle® Libre 2 iOS app received approval from the FDA for adults and children ages 4 and up with diabetes. This app is used with the Abbott FreeStyle® Libre 2 CGM system, which was approved on June 15, 2020. Prior to this approval, FreeStyle® Libre 2 users had to wave a reader over the glucose sensor. Now, they can use their iPhone instead.
• The Bigfoot Unity™—a Bluetooth-enabled insulin pen cap—received FDA clearance for individuals 12 and older. For the first time, people who use multiple daily injections (MDI) to manage their diabetes will be able to integrate with a continuous glucose monitor and get personalized insulin dosing recommendations, lessening the burden of T1D.

Insulin

• The FDA approved Semglee® (insulin glargine-yfgn), a long-acting insulin, as the first ever interchangeable biosimilar insulin product, for adults, children, and teens with T1D (and adults with type 2 diabetes). It is biosimilar and interchangeable to Lantus®, a long-acting insulin, and may now be substituted for the prescribed reference product (Lantus®) at the pharmacy counter.
• Walmart will sell the ReliOn™ label insulin, NovoLog® (insulin aspart), a rapid-acting insulin, and NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart), a rapid-acting insulin plus intermediate-acting insulin that works up to 24 hours, for use in adults and children with diabetes. The cost is $72.88 for 10mL insulin vials or $85.88 for a package of five FlexPens®.
• The FDA approved an expanded label for the rapid-acting insulin, Lyumjev® (insulin lispro-aabc injection) 100 units/mL, for use in insulin pumps for people with diabetes. (It was first approved by the FDA in June 2020.) As a rapid-acting mealtime insulin, Lyumjev helps control blood-sugar levels after meals in adults with diabetes.

Infusion Set

• The FDA has approved Medtronic’s Extended Wear Infusion Set (EWIS), which is the first infusion set approved for seven days. No other infusion set is currently approved for more than three days.

Hypoglycemia

• The FDA approved Zegalogue® (dasiglucagon) injection, for the treatment of severe hypoglycemia in children and adults with diabetes aged 6 and above. Its approval was based on results from three clinical trials, showing an average time to blood sugar recovery of 10 minutes following injection. This is the fourth FDA approval of a glucagon treatment for severe hypoglycemia, providing people with choice for which Breakthrough T1D strongly advocates.

6. Artificial Pancreas Systems: Three at the FDA

With your support, we have ushered in therapy innovations that have made managing T1D easier and have led to improved health outcomes.

The most noticeable impact is in the influx of diabetes devices that have made T1D easier to control and have freed people from the constant worry about their disease. A significant milestone—or three to be exact—is that three artificial pancreas systems—Tidepool Loop, Omnipod 5, and Medtronic MiniMed™ 780G—have been submitted for FDA review.

The Tidepool Loop is an iPhone app that brings together an insulin pump, CGM, and automated insulin dosing algorithm that adjusts to the user’s basal rates as often as every five minutes and allows the wearer to bolus from the phone. The Omnipod® 5 System is the first and only tubeless artificial pancreas system, which pairs its disposable insulin pump (which you can change every 3 days) with a Dexcom G6 CGM. And the Medtronic MiniMed™ 780G is an update on the 670G, which was approved in 2016, and has a time-in-range of around 75 percent.

7. A Potential First-in-Class Adjunct Therapy

The FDA granted Breakthrough Therapy designation for vTv Therapeutics’ TTP399 as an adjunct therapy to insulin for T1D. Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious and life-threatening conditions.

In a Breakthrough T1D-funded phase II clinical trial called Simplici-T1, TTP399 significantly improved HbA1c in people with T1D. Additionally, trial participants who received TTP399 showed a reduction in insulin dose, reduced hypoglycemia, and no increase in diabetic ketoacidosis (DKA).

The next step: A phase III clinical trial.

8. Leading Immune-Mediated Organizations Unite

Did you know that people with T1D are more likely to have a coexisting autoimmune disease? And someone with T1D is at a more than 3-fold increased risk of developing multiple sclerosis, as compared to someone who does not have type 1? And, if you have T1D and lupus, you are more likely to develop kidney complications, as opposed to people with just one disease.

That’s why Breakthrough T1D partnered with the Lupus Research Alliance and the National Multiple Sclerosis Society to advance the understanding of autoimmunity and to obtain more specific insights into commonalities and differences of immune pathways that govern these disease processes. The researchers will get a maximum of $450,000 for up to 2 years to generate the first tranche of results from their projects.

9. Eli Lilly Acquires Protomer Technologies

The Breakthrough T1D T1D Fund portfolio company Protomer Technologies has been acquired by Eli Lilly and Company. Protomer is developing glucose-sensing, or “smart,” insulin, which is designed to sense sugar levels in the blood and automatically activate as needed throughout the day. Smart insulin has the potential to revolutionize the treatment and quality of life of people with diabetes by improving both the effectiveness and safety of insulin therapy and significantly reducing the risks of both dangerous high and low blood-glucose episodes and life-threatening complications, leading to healthier, longer lives.

Breakthrough T1D has been an early supporter of smart insulin (also called glucose-responsive insulin, or GRI), and Breakthrough T1D and the T1D Fund have supported Protomer from before the company’s inception through its sale to Lilly. In 2013, Alborz Mahdavi, Ph.D., was a winner of the Breakthrough T1D Agnes Varis GRI Grand Challenge Prize. Subsequently, he founded Protomer, which was initially funded by Breakthrough T1D’s Industry Discovery and Development Program.

Following these successful grants from Breakthrough T1D, the T1D Fund made a minority equity investment in Protomer’s Seed round, alongside Eli Lilly, to advance the company’s highly promising glucose-sensing insulin program.

The successful sale of Protomer to Eli Lilly is a great example of how Breakthrough T1D research, the T1D Fund, and key diabetes industry players collaborate as a part of a larger ecosystem to help advance meaningful therapies for the T1D community.

10. Breakthrough T1D Centers of Excellence

A notable addition in our progress toward improving lives and curing T1D is the establishment of the Breakthrough T1D Centers of Excellence. There are now a total of five Breakthrough T1D Centers of Excellence: New England, Northern California, University of Michigan, Australia, and the University of British Columbia. These Centers of Excellence represent concentrated investments toward our goals by tackling a myriad of scientific questions that a single lab cannot undertake. By bringing together world-class, interdisciplinary research talents and resources at and across partner institutions, we are changing how we approach T1D research.

Movers, Shakers, T1D Changemakers

Your partnership is inseparable from these advances and many more. On behalf of our community, thank you for shaking things up—for more progress, more advancements, and more access—for everyone impacted by T1D.

Type 1 diabetes (T1D) and sleep, or lack thereof, are often tied together. Someone living with T1D must navigate a wide range of challenges that can impact sleep, and poor quality of sleep negatively affects your psychological and physical health.

In addition, one of the greatest fears of nighttime is low blood sugar (called hypoglycemia), which occurs when blood-sugar levels fall below 70 mg/dL. Symptoms can include shaking, an accelerated heart rate, and clammy skin. It’s possible to sleep through a hypoglycemic event, but you can wake up tired, confused, sweaty, and can feel lethargic or foggy.

But artificial pancreas systems are changing that.

Artificial pancreas systems (also called automated insulin delivery systems) have two interrelated functions: Monitoring the blood-sugar levels in your body (through a continuous glucose monitor) and automatically providing insulin to keep them in a healthy range (through an insulin pump), via a smart algorithm. By automating much of blood-sugar management, these systems can help improve diabetes-related outcomes and lighten the burden of T1D.

Even during sleep.

Time-in-Range and Sleep

Time-in-range (TIR) is a measurement that tells you what percentage of the day your blood sugars are in your goal range (typically 70-180 mg/dl). The American Diabetes Association recommends that people with diabetes spend 70% of their time in the target range, meaning you should aim for roughly 17 out of 24 hours each day to be in range. Unfortunately, less than half of the diabetes population meets this recommendation.[i]

But experts emphasize that even a 5% improvement in TIR—let’s say, going from 60% to 65%—is meaningful, as it translates to one more hour per day spent in-range.[ii]

Now, let’s look at some recent scientific findings in the table below.

Not only can the artificial pancreas systems improve time-in-range, but they can dramatically improve time-in-range during sleep. 

Note: Left click on image to enlarge. 

More time-in-range, even when you’re asleep.  Now that’s research that can help you rest easy and more often than not, wake up on the right side of the bed.

Have a goodnight!

Watch Breakthrough T1D’s and Tandem’s Facebook Live event (video below) exploring AP systems and improvements in TIR and sleep.

Editor’s Note: This educational content is made possible with support from Tandem Diabetes Care. Breakthrough T1D produces this content to provide information to our supporters about their potential options for managing their T1D and not as an endorsement of products. Editorial control rests solely with Breakthrough T1D. 

RX ONLY. The t:slim X2 insulin pump with Control-IQ technology is indicated for patients with type 1 diabetes, 6 years and older. BOXED WARNING: Control-IQ technology should not be used by people under age 6, or who use less than 10 units of insulin/day, or who weigh less than 55 lbs. For full safety information, visit tandemdiabetes.com/safetyinfo. 

[i] Bergenstal RM, Hachmann-Nielsen E, Tarp J, Kvist K, Buse JB. 65-LB: Real-World Continuous Glucose Monitoring Data on Time-in-Range from a U.S. Population, 2015–2019. Diabetes Jun 2021, 70 (Supplement 1); doi: 10.2337/db21-65-LB

[ii] https://diatribe.org/diabetes-technology/cgm-and-time-range-what-do-diabetes-experts-think-about-goals

[iii] Breton MD, Kovatchev BP. One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology. Diabetes Technol Ther. 2021; 23 (9): 601-608. doi:10.1089/dia.2021.0097

[iv] DuBose S, Bauza C, Verdejo A, Beck RW, Bergenstal RM, Sherr J. Real-world, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes using the MiniMed 670G Hybrid Closed Loop System. Diabetes Technol Ther. 2021; 10.1089/dia.2021.0176. doi:10.1089/dia.2021.0176

[v] https://news.medtronic.com/2021-06-02-Real-World-Data-on-Over-4,000-Patients-Using-the-Medtronic-MiniMed-TM-780G-System-Demonstrate-Time-in-Range-Mirroring-Pivotal-Trial

[vi] Lewis DM, Swain RS, Donner TW. Improvements in A1C and time-in-range in DIY closed-loop (Open-APS) users. Diabetes. 2018; 67: 352-OR. https://diabetes.diabetesjournals.org/content/67/Supplement_1/352-OR.abstract.