Hey, Diabetes Community! It’s a tradition here at the ‘Mine to essentially “call the diabetes advocacy organizations to the mat” at the end of each year by asking them to share with the community what milestones they’ve achieved, and what they hope to accomplish in the new year ahead.
This year, we queried seven leading U.S. diabetes non-profits: What did they actually achieve in 2018? And what do they plan to make happen in 2019? Below are the answers from their various leaders and spokes-folks.
Note: There’s a ton of great info here about what’s happening in the Diabetes World, so we invite you to settle in with a cup of coffee, or even consider printing this piece out for further review… and of course, please share your thoughts via social media or email!
As 2018 comes to a close, we are pleased to reflect on a year of success, effective advocacy and passionate dedication to drive the American Diabetes Association’s (ADA’s) policy priorities forward on the part of our staff, and more importantly, on the part of Diabetes Advocates across the nation. And as we look to the future, 2019 promises to be a year of change and opportunity. We look forward to working with each of the 100 first time members of Congress arriving in Washington in January, as well as the countless other elected officials, partners and opinion leaders around the nation to ensure that diabetes is highest priority in our collective work.
Protecting Access to Affordable Care:
In 2018, the ADA continued to defend the Affordable Care Act (ACA) against efforts to weaken the law and rollback important protections for people with diabetes at both the state and federal levels. In addition to the work done at the federal level, the ADA’s State Government Affairs Program, working in conjunction with our Policy Department, opposed legislative threats to ACA coverage and supported legislation taking action to further protect that level of coverage in states.
In June, the ADA signed onto an amicus (friend of the court) brief defending the ACA against a lawsuit challenging the constitutionally of the law. The lawsuit, which was filed in February, was led by the Attorney General of Texas and included twenty states challenging the constitutionally of the ACA. The lawsuit argues that because of the repeal of the ACA’s individual mandate tax penalty, the entire law is no longer valid. In 2012, the Supreme Court upheld the ACA saying that the law was valid because Congress has the authority under the Constitution to levy taxes.
The ADA joined with the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the National Multiple Sclerosis Society in filing the brief. While the brief does not make the ADA a legal party in the case, it does bring to the court’s attention the ADA’s significant interest in protecting the ACA for people with diabetes. The ADA provided research used in the brief on how people with diabetes would be impacted if the ACA, including the law’s important consumer protections, would be ruled unconstitutional.
In September, the U.S. District Court in Texas heard oral arguments on the lawsuit. During the hearing, the brief we filed was discussed by the defendants (supporters of the ACA). The defendants talked about how people with diabetes, cancer and other diseases would be hurt if the ACA was overturned. The next step is for the judge to issue a decision in the case. As of this writing, the judge has yet to issue a decision, but it is expected to be issued very soon. Whatever decision is made, it will likely be appealed, and the case will continue to move through the court system possibly ending in the Supreme Court.
Call to Congress 2018:
More than 150 diabetes advocates, researchers and professional football players from across the country convened on Capitol Hill for the ADA’s annual Call to Congress Advocacy Day on March 22. The group held more than 170 meetings with Congressional offices to urge policymakers to make diabetes a national priority. Diabetes Advocates asked Congress to increase federal funding for diabetes research and programs, make insulin affordable, and protect access to adequate and affordable health insurance for people with and at risk for diabetes. ADA’s Chief Scientific, Medical and Mission Officer William T. Cefalu, MD, presented the key findings of the Economic Costs of Diabetes in the U.S. report at a press conference. Dr. Cefalu was joined by the co-chairs of the Senate Diabetes Caucus, Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), who spoke about their efforts to support people with diabetes and their continued commitment to ensuring federal funding for diabetes research and programs.
79th Scientific Sessions:
The ADA’s annual Scientific Sessions continued to bring together the world’s best and brightest scientific minds to share cutting-edge research on nearly every aspect of diabetes. Hosted in Orlando this year, the five-day meeting drew more than 14,000 researchers, physicians, health care professionals, advocates, and media to discuss the latest and most important research findings and continues to be among the top diabetes meetings worldwide. Highlights from the 2018 Scientific Sessions can be found here. The 2019 Scientific Sessions will be held June 7-11 in San Francisco!
In November, the ADA celebrated the second anniversary of the Make Insulin Affordable initiative. To date, more than 415,000 Diabetes Advocates have joined the call for affordable insulin for all who need it—the largest response to an ADA call to action to date. Diabetes advocates called for Congressional hearings to investigate the reasons for the dramatic increases in insulin costs. The U.S. Senate Special Committee on Aging answered with a hearing in May of this year. Chief Scientific, Medical and Mission Officer William T. Cefalu, MD, testified about the impact of the high cost of insulin on people with diabetes. In addition, after its examination of the insulin supply chain, the ADA’s Insulin Access and Affordability Working Group (Working Group) published recommendations and the ADA outlined public policy solutions to address the problem. The ADA will continue to work with various stakeholders including policy leaders to develop and implement viable, long-term solutions to ensure access to affordable insulin for all who need it.
Commercial Drivers Advocacy Victory:
The ADA celebrated a historic victory when the U.S. Department of Transportation, Federal Motor Carrier Safety Administration (FMCSA) released its new rule permitting individuals with insulin-treated diabetes to be certified to operate commercial motor vehicles in interstate commerce. The final rule is the culmination of more than two decades of advocacy by the ADA and will allow individuals on a stable insulin regimen to operate commercial vehicles without needing to obtain an exemption.
Hurricane Relief for People with Diabetes:
The 2017 efforts of the Diabetes Emergency Relief Coalition (DERC), convened and led by the ADA, werr recognized with the American Society of Association Executives (ASAE)’s 2018 Summit Power of A Award for the group’s hurricane relief efforts in providing more than 4,600 pounds of diabetes supplies to individuals left without access to water and electricity in the wake of Hurricanes Harvey, Irma and Maria. The Coalition was launched by the ADA, JDRF and Insulin for Life USA in 2017, and members include the Endocrine Society, American Association of Clinical Endocrinologists (AACE), American Association of Diabetes Educators (AADE), Research!America and T1D Exchange.
In 2018, the DERC, renamed the Diabetes Disaster Response Coalition (DDRC), was co-led by the ADA and Insulin for Life USA, and continued to provide support to those affected by hurricanes and other natural disasters including wildfires and flooding. Efforts included printable documents including how to build a diabetes emergency plan and kit; how to safely store insulin in the event of an emergency; how to safely switch from one insulin to another if your usual insulin is unavailable; and providing resources and support through the ADA Call Center at 1-800-DIABETES. And, importantly, Insulin for Life USA continues to collect unexpired and unopened diabetes supplies for certification and redistribution to those in need.
Updated Standards of Care:
The 2018 Standards of Medical Care in Diabetes continued to serve as a living document throughout 2018. Live updates included the revised definition of hypoglycemia, which categorizes it into three levels, and the updated FDA recommendations for SGLT2 inhibitors and GLP-1 receptor agonists to reduce cardiovascular disease risk.
For the 2019 Standards of Care, publishing December 17, 2018, the most notable updates include the patient decision pathway, an extensive chapter on cardiovascular disease risk, which is endorsed by the American College of Cardiology for the first time, and the consideration of treatment costs for patients. Most importantly, the ADA recommends that providers develop a diabetes care plan through a shared patient-provider decision cycle that considers all patient factors including cost.
Diabetes Food Hub:
The ADA released the Diabetes Food Hub, a new digital recipe platform for people with diabetes. The website features hundreds of healthy, ADA-approved recipes with easy-to-read nutrition guidance, tips for healthy eating and meal prep inspiration. Recipes can be searched by cuisine types such as comfort food, Mediterranean, Southwest, and more, as well as filtered by preferences such as low-carb, low-sodium, vegetarian, budget-friendly, or gluten-free. By creating a free profile, users can also enjoy a personalized experience, as the site learns likes and dislikes over time and offers suggestions based on past user preferences. Users can drag-and-drop recipes into a weekly Meal Planner, which automatically calculates nutrition information, and creates an editable shopping list.
Know Diabetes by Heart:
In 2018, the ADA launched a landmark initiative in partnership with the American Heart Association—
The ADA will push to ensure children with diabetes can access school and childcare programs safely by continuing to pursue litigation against the New York City public school system and the U.S. Army Child, Youth & School Services.
We will continue to work at the state and federal levels to ensure people with and at risk for diabetes have affordable access to health care coverage.
We will advocate for public policies that will bend the curve and help prevent type 2 diabetes in high-risk populations.
We will work to promote health equity and eliminate health disparities.
2019 promises to be another stellar year for the ADA! The ADA is poised and ready to continue to improve health outcomes and quality and length of life for the millions of Americans living with diabetes.
For AADE, 2018 has been a year that has seen change manifest itself in a variety of new resources, legislative bills, initiatives and partnerships that are truly re-writing how and where we engage in diabetes care. Here are our 2018 highlights and where we are headed in 2019:
An assessment of AADE members found that while diabetes educators had a need for the latest information on diabetes devices, technology, mobile apps and more, there was no central place for them to access this information and training. Enter DANA. Diabetes Advanced Network Access, or DANA, was launched in 2018 to fill this gap and provide healthcare professionals with a robust, reliable resource on the devices, expertise and innovations shaping diabetes care. The Helmsley Charitable Trust recognized this value and awarded AADE a $2.2 million grant to enhance and expand DANA over the next three years. Learn more about DANA at DANAtech.org.
AADE, both as an organization and through its partnerships and coalitions, has worked with local, state, and federal policymakers to ensure the interests of people with diabetes and diabetes educators are represented. AADE’s advocacy priorities have included supporting policies that ensure protections for people with pre-existing conditions and advocating for improved transparency in medication pricing. Recently two federal bills were passed removing pharmacy “gag clauses” that prohibit pharmacists from informing customers that their medicine may be cheaper if they pay cash rather than using their health insurance.
AADE has also worked to address non-medical switching and step therapy on the state and federal level so people with diabetes can stay on their prescribed medications. AADE recently wrote to Medicare to express concerns with a policy change that would allow Medicare Advantage plans to use step therapy to control costs. Plans are already underway at AADE to develop a toolkit and other resources that diabetes educators can use to educate and empower people with diabetes to stay on their prescribed medications when faced with non-medical switching. Look for more updates in early 2019 at DiabetesEducator.org/advocacy.
Access to both medications and DSMES services has been an important advocacy initiative. In 2018, AADE worked with the Diabetes Advocacy Alliance (DAA) to draft, introduce, and advance the Expanding Access to Diabetes Self-Management Training (DSMT) Act (H.R. 5768, S. 3366), with plans to reintroduce the bill in 2019. This important piece of legislation will help remove barriers to diabetes education for Medicare beneficiaries, such as eliminating cost requirements.
And in late October, AADE was pleased to announce that Jasmine Gonzalvo, PharmD, BCPS, BC-ADM, CDE, LDE, FAADE had received an appointment to serve on the U.S. Department of Health and Human Services’ National Clinical Care Commission. We hope that Jasmine can serve as voice for people with diabetes and diabetes educators in national policy discussions.
AADE has been and will continue to be very involved in the newly formed Diabetes Disaster Response Coalition to support people with diabetes in disasters. During the 2018 hurricane season, AADE coordinated with volunteers to get important information to those in affected areas.
New Models of Care
In 2018, AADE completed year one of our 5-year cooperative agreement with the Centers for Disease Control and Prevention to engage communities with an increased risk of developing type 2 diabetes but limited access to programs that prevent or delay T2D. AADE has enrolled 480 participants to date, who have lost a combined 2,102 lbs! We plan to enroll 5,000 individuals over five years, with a special focus on Latinos, African Americans, Medicare beneficiaries, and people living in rural, underserved counties. Learn more at DiabetesEducator.org/prevention.
AADE also hosted a population health summit at AADE18 to conduct a dialogue around the current and future roles of diabetes educators and identify areas of collaboration and mutual support. Look for new initiatives in 2019 around this booming area of health care.
Study after study has shown the positive impact of peer support (both online and in person) on people with diabetes. Yet, like diabetes education services, it is often underutilized by the larger population affected by diabetes. In 2018, AADE ramped up work with peer support communities to build relationships and raise awareness of this vital tool. New resources include a peer support hub at DiabetesEducator.org/peersupport and a handout for healthcare professionals and their patients. Stay tuned in 2019 for more on this growing initiative.
New Practice Guidance
AADE provided guidance to help diabetes educators best serve individuals affected by a variety of diabetes-related issues. These included new resources around mental health, obesity, CGM, gestational diabetes, continuous subcutaneous insulin infusion, vaccinations and the use of glucose meters in type 2 diabetes management. In 2019, AADE plans to release additional guidance on issues impacting the diabetes care space such as population health, cultural competency and health literacy, peer support and more.
New Vision for the Specialty
AADE has begun a multi-year initiative to optimize outcomes for people with diabetes and position diabetes educators for success within a value-based healthcare environment. This new vision for the specialty of diabetes education will elevate and highlight the role they play as integrators for clinical management, education, prevention and support. Over the last year, AADE engaged members, providers, patient advocates, healthcare organizations and other key stakeholders to understand where the specialty currently sits and where it needs to be headed in order to best serve people with diabetes. Stay tuned in 2019 for additional updates on a vision for the specialty of diabetes education.
Collaboration is the 2018 word of the year at Beyond Type 1. We’ve added an exciting range of new programs to the Beyond Type 1 umbrella by partnering with existing organizations or individuals with great ideas and big dreams. Our goal is to fill the gaps between diagnosis and cure by uniting the global diabetes community and offering programs that make life better for anyone impacted by T1D.
In 2018, Beyond Type 1:
Added 5 new programs to the Beyond Type 1 network: Type One Run, SafeSittings, Jesse Was Here, Diabetes Scholars, and Slipstream Weekends. Each of these programs is built on the previous work of superstar organizations and individuals – Beyond Type 1 is thrilled to grow their reach and impact for the benefit of the diabetes community.
Hit exciting milestones for ongoing programs. Jerry the Bear is headed to multiple clinics as part of a pilot to reach newly diagnosed families through our Give-A-Bear program.
The DKA Awareness Campaign is expanding thanks to a grant of $300,000 from the The Leona M. and Harry B Helmsley Charitable Trust. The 2018 Beyond Type Run team — 20 adults with Type 1 diabetes — took on the New York City Marathon. Bike Beyond The Documentary has been featured at over 100 community screenings in 10 countries around the world.
Created new campaigns addressing issues core to the diabetes community. In May, Beyond Type 1 published Previously Healthy. This longform journalistic story takes a close look at Reegan Oxendine’s tragic death, raising awareness for Type 1 diabetes and for DKA. This Fall, we hosted Diabetics on the Margin in partnership with Ariel Lawrence. This event and panel discussion was a first step in conversations about diversity in the online diabetes landscape. In 2018 Beyond Type 1 also partnered with Dexcom to lead community-based survey research about awareness and access to CGM, and the results were published this November as part of a broader Diabetes Awareness Month partnership with Dexcom. For World Diabetes Day we celebrated Banting’s Birthday with a digital birthday card for Frederick Banting — 2018’s celebration featured almost 50 partners and a Guinness World Record attempt!
Made significant additions to our leadership, including the launch of the new Family Council. We’ve also added members to the Board of Directors, Leadership Council, Scientific Advisory Council, and Global Ambassador Councils.
Reached outside of the diabetes network to raise awareness and funds through strategic partnerships with global brands like Panera Bread and Veronica Beard.
Served as members and thought partners on the Diabetes Disaster Response Coalition (DDRC), the Diabetes Patient Advocacy Coalition (DPAC), the Diabetes Policy Cooperative (DPC), and Project ECHO with Stanford University.
Continued building community through publication of personal stories, resources, and breaking news on Beyond Type 1 and Beyond Type 1 en Español. We encouraged conversation and connection in the Beyond Type 1 app as well was TuDiabetes.org and EsTuDiabetes.org. We continued sharing the ways individuals #livebeyond Type 1 diabetes through our social media campaign. We are now serving over 1 million people each month across our web platforms.
In 2019, Beyond Type 1 is primarily focused on expanding existing programs and campaigns. The DKA Campaign will be entering phase two thanks to support from the Helmsley Trust. We’re also planning four Slipstream weekends for adults with Type 1 diabetes with our friends at Connected In Motion.
Our Beyond Type Run NYC Marathon Team will enter its third year. In terms of new work, we’re working to on expand our presence internationally with resources specific to non-US countries and non-English speakers. Beyond Type 1 is excited to collaborate with new and existing partners in the new year, and of course we’ll have a number of exciting surprise announcements as Beyond Type 1 continues to grow and expand.
2018 was another year of amazing growth for CDN. We’ve added new staff members, launched an updated website and released new resources for young adults with diabetes and their families. Read on to learn about our year and what we have planned for 2019!
- Updated Off to College Booklets – Since 2016, we have distributed over 100,000 printed Off to College booklets! We are happy that so many families have benefited from these booklets in the last two years. This year, we decided to update the Off to College booklets based on feedback from parents and students. These new booklets, which were released in March, have information on T1D accommodations during standardized testing, managing caregiver/student communications away from home, and more. Order your printed or digital copies here!
- Conferences – As part of our Next Gen leadership program, we brought 19 students to diabetes conferences all over the country, including ADA, CWD, and AADE. These students were able to learn the latest in diabetes care and research, meet mentors in the field, and explore future career opportunities. We also sent staff to eight diabetes and campus related conferences. These conferences allow us to present about our programs and research, while informing clinicians, campus administrators, and families about our resources while we network with other youth and diabetes nonprofits and organizations.
- Off to Work –In May, we released our newest resource for young adults with T1D, our Off to Work guide. This guide covers everything you need to know about work place rights and accommodations, “adulting”, and thriving with T1D. Whether you are going from high school to the workplace, starting an internship, or going off to your first job post-college, this guide has you covered. Request your digital copy here.
- CDN Annual Retreat – In May, we brought 25 of our student leaders to the 5th annual retreat in Bridgton, Maine. Students spent a week learning about leadership, talking through challenges, and bonding. This year we added an Innovation Fair where our students were able to meet with representatives from companies across the diabetes sector. They learned about the newest innovations that will impact their lives and were able to give feedback on products and ideas. You can watch our video and see what the Innovation Fair was all about!
- Website Refresh – In November, we launched our updated website! This update includes new navigation which makes it easy to find what you need, when you need it. Take a look here!
- College Diabetes Week 2018 – We just wrapped up our 5th annual College Diabetes Week! We had lots of participation from Chapters, students, and alumni. We had themes for each day, from how to manage “adulating” and T1D to leadership. Check out our Facebook album here to see what our members had to say about living with T1D as a young adult.
- 2018-2020 Strategic Plan – In early 2018, we released our strategic plan. Our CEO and founder, Christina Roth, wrote about this for our blog. As you can see from the above, we are busy working to meet our goals by our 10 year anniversary in 2020!
- College Campuses – By the end of 2019, our goal is to have served 1,000 campuses across the country! Are you on a campus and want to be involved? Let us know! We will also be launching our campus toolkit materials nationwide in 2019. We completed our pilot run of the materials in 2018 and are busy updating content based on feedback from our Campus Advisory Committee. These toolkits will be for campus administrators, such as disability services, health centers, and counseling offices and include the information they need to know to best support T1D students on their campuses. Sign up here for our newsletter to be the first to know when these launch.
- Clinics – To better support our clinicians and clinic partners, we will be launching CDN resource bundles. These bundles will allow clinicians to easily order all of our CDN resources in one click, including Off to College Booklets, You’ve Got This (a guide for T1D diagnosis as a young adult), and the Off to Work Guide. These bundles will ensure that medical professionals have the resources they need on hand to help their patients.
- Conferences – We will be attending seven diabetes and campus conferences in 2019. We will be brining approximately 19 students again to network, learn, and grow. Look out for applications to attend a conference with us in late January.
- Chapters – We anticipate reaching 150 formally affiliated CDN Chapters by 2019, with a presence in almost every state. Our Chapters remain a vital part of CDN – a way for young adults to connect with one another, share challenges and solutions, and build community. Want to get a Chapter started on you campus? Start here.
- Leadership Summit and Regional Retreats – As CDN has grown, so has our need for providing leadership opportunities for more Chapter leaders and members. We will be piloting regional retreats, allowing Chapter leaders to better network, share ideas, bond, and gain new skills. We will also be hosting a leadership summit in Boston in April.
- College Diabetes Week 2019 – We are already thinking of themes and plans for the 6th College Diabetes Week. Keep an eye out for more information in early fall 2019.
- DPAC hosted its first Policy Training Meeting, bringing 28 passionate advocates from across the country to D.C. for intensive educational sessions on policy. These individuals met with over 30 Congressional offices to discuss affordable access to insulin and asking for cosponsors for the Diabetes Self-Management Training bill. The Endocrine Society joined us for these meetings and we jointly presented at a standing-room only Congressional Staff briefing. These DPAC advocates are part of our new program: DPAC Champions, and will help advocate for our community on federal and state issues.
- DPAC entered into a memorandum of understanding with two prominent organizations: Lions Clubs International and the Association of Black Cardiologists, providing opportunities to elevate diabetes policy issues within both organizations.
- Our DPAC Patient Advisory Board was formed and currently meet to provide a robust representation of different voices in our community. They advise and provide insight on particular issues, acting as DPAC spokespeople at state and federal levels.
- DPAC hosted the second annual CAPS (Community Advocacy Policy Summit), bringing together all national diabetes nonprofits and industry for crucial conversations about challenges and opportunities to collaborate. From this meeting, a nonprofit working group for two projects was formed.
- DPAC’s CEO had an op-ed in The Hill regarding copay accumulator adjustment programs, bringing to light the damaging practice by insurance companies to prevent manufacturer payments from copay cards being applied to deductibles.
- After advocating since DPAC’s inception to alter the Competitive Bidding Program (CBP) for diabetes testing supplies through its National Mail Order Program, the community received a huge win when the language from H.R. 3271 (Protecting Access to Diabetes Supply Act of 2017) was rolled up into the Bipartisan Budget Act of 2018 in January. Currently, the CBP has been suspended, which prevents the provisions in the law to be enacted, but we expect the next round of CBP to begin soon.
- DPAC launched a grassroots campaign to help ensure those on Medicare would be reimbursed for their CGM system if they viewed or shared their data on a smart device. DPAC’s CEO represented the patient voice at a multi stakeholder meeting with CMS’s Principal Deputy Administrator of CMS, Demetrios L. Kouzoukas regarding this issue, with a new ruling allowing smart device viewing less than a week later.
- We continued to be part of a coalition to provide CGM access for California Medi-CAL beneficiaries. Undeterred by last year’s veto by Governor Brown, this year’s effort was through a line item in the state budget. Unfortunately, the department chose to remove the item. We will continue with coalition work in California and discuss the importance of access with the new state administration.
- DPAC provided policy advocacy sessions at CWD’s FFL in Anaheim, Orlando, and Falls Church; The College Diabetes Network (CDN) Annual Student Retreat in Maine; AADE’s Policy Forum in Chicago; AADE’s annual conference in Baltimore and the Advamed Diabetes Congressional Showcase in D.C. Topics varied from CBP and affordable access to insulin to overviews of the current diabetes policy landscape and ways to advocate.
- DPAC is part of the American Association of Clinical Endocrinologists (AACE)-led IDEA Project, which will hopefully elevate CGM usage and understanding to a broad portion of the diabetes population. We also participated in the American Diabetes Association’s Therapeutic Inertia Summit and will continue to provide the patient voice on this multi-year effort.
- The issue of CMS’s lag on approving reimbursement for diabetes technology has created a working group from both industry and nonprofits, including JDRF, ADA, and DPAC, to help guide CMS through the next generation of access to the technology needed by the Medicare population.
- We have provided testimony and written statements on several state issues related to transparency, restrictive Medicaid formularies, non-medical switching, and affordable access to insulin.
- DPAC worked with the Congressional Diabetes Caucus on their white paper for Insulin Affordability and helped disseminate the findings to the community. We continue to work closely with the Caucus staff to provide the trusted patient voice in finding a solution.
DPAC will continue to be a trusted patient voice on Capitol Hill, working with Congress and the Congressional Diabetes Caucus on DSMT for Medicare and the Diabetes Vision Loss and Blindness Prevention Act in the 116th Congress. As legislative solutions begin to be presented into Congress and state legislatures regarding affordable access to insulin, we will create campaigns to bolster multi-stakeholder efforts to find relief and ensure no one lacks insulin in the United States. Our efforts in state legislatures for a multitude of important issues will continue through community-driven grassroots opportunities.
We will continue to offer the DPAC Policy Training Meetings in D.C. and will invite other organizations to join us for Congressional Briefings and meetings on Capitol HIll. The DPAC Champions program will help those interested in raising their voice on issues relating to safety, quality, and access will receive additional training and opportunities.
As we believe that collaboration across diabetes nonprofits is key to ensuring our community has affordable access to safe devices, medications, and services, we will continue our Community Advocacy Policy Summit and provide opportunities to work together on projects, grassroots lobbying, and direct lobbying.
As the leading global organization funding T1D research, JDRF’s mission is to improve lives today and tomorrow by accelerating life-changing breakthroughs to cure, prevent and treat T1D and its complications. As we relentlessly work toward a cure, JDRF supported more than 70 human clinical trials and 500 active research grants in 2018. Select highlights include:
- In partnership with the Mary Tyler Moore and Robert S. Levine Charitable Foundation, the “Restoring Vision: A JDRF Moonshot Initiative” launch brought together global experts in diabetes-related eye diseases and related disciplines, including engineers, cell biologists and technology experts, to develop a research plan to reverse low vision in people with T1D.
- With The Leona M. and Harry B. Helmsley Charitable Trust, JDRF renewed $15 million in funding for the Network for Pancreatic Organ donors with Diabetes (nPOD) to continue transformative research into how and why T1D develops. nPOD is the world’s largest biobank of pancreatic tissue, supporting more than 300 investigators in 20 countries and processing 50,000 tissue samples for analysis.
- JDRF-funded researchers at the University of Alabama at Birmingham published a study in Nature Medicine, which found that verapamil, a common blood pressure medication, promotes insulin production in adults with recent-onset T1D by preserving beta cell function when added to a standard insulin regimen. These findings mark the first effective, non-immunosuppressive therapeutic approach to help target loss of beta cell function in T1D.
- Until now, JDRF has not been able to analyze clinical studies of T1D in a way that tells us why some children who are at risk get T1D and others do not. We are excited to be collaborating with IBM to develop and apply world-class computing power to analyze years of global T1D research data and identify factors leading to the onset of T1D in children. By developing a better understanding of risk factors and causes of T1D, we hope to eventually find a way to prevent the disease entirely.
- JDRF is committed to advancing artificial pancreas technology, which is why we undertook the Open Protocol initiative, whereby an insulin pump, a CGM and an algorithm “talk” to each other, regardless of whether they have the same manufacturer. In December 2018, along with the Helmsley Charitable Trust, JDRF announced a collaborative grant agreement to provide Tidepool with a $6 million funding commitment to begin developing Tidepool Loop, a hybrid closed loop automated insulin delivery app, for the iOS App Store as an FDA-regulated mobile application. This project will demonstrate the power and value of an interoperable ecosystem of diabetes devices, giving more options for better control with less burden.
JDRF had a significant presence at major conferences in the T1D space, including:
- American Diabetes Association Scientific Sessions: Researchers presented 60 JDRF-funded studies, encompassing clinical trials and research studies that are paving the way to novel and emerging treatments for T1D.
- European Association for the Study of Diabetes Annual Meeting: Researchers presented 45 JDRF-funded studies, sharing updates on closed-loop AP systems, prevention trials, new concepts in beta cell regeneration and the connection between T1D and kidney disease.
- Immunology of Diabetes Society Congress: Researchers presented 50 JDRF-funded studies, including progress from The Environmental Determinants of Diabetes in the Young (TEDDY) study, T1D TrialNet clinical trials and INNODIA global partnership.
Driving Progress Across the Pipeline
- This year, there was an important step forward for a new drug to improve glucose control in adults with T1D, called Zynquista™ (sotagliflozin). JDRF was one of the first to support a clinical trial to see if the drug worked in T1D. In this and later clinical trials, sotagliflozin showed a significant reduction in HbA1c, and also improved other key health measures. If approved by the FDA, it will be the first example of an oral drug approved for T1D, prior to seeking approval for type 2 diabetes.
- JDRF has made beta cell replacement a priority, and is funding multiple scientific approaches. This year, a pharmaceutical company committed to moving one of these approaches forward. Eli Lilly will collaborate with Sigilon Therapeutics to develop encapsulated cell therapies for T1D, using technology that began with JDRF funding. Encapsulation technologies can “shield” beta cells so that they are protected from immune attack. At JDRF, we have been funding encapsulation research for more than 10 years, and among the first efforts were several grants to Daniel Anderson, Ph.D., and Robert Langer, Sc.D. Their research eventually led to the discovery of an encapsulation platform that led them to found Sigilon Therapeutics. The Lilly-Sigilon partnership is an extraordinary step forward for the entire T1D community.
Investing in Innovation
- After an 18-month campaign from JDRF and supporters across the country, Congress approved legislation in February for a two-year extension of the Special Diabetes Program (SDP), providing $300 million for type 1 diabetes (T1D) research through the National Institutes of Health. As a result, SDP-funded researchers around the country were able to continue large-scale clinical trials without interruption, and new research was launched.
- During the year, JDRF advocates also urged their Members of Congress to provide strong annual funding for the National Institutes of Health to complement the SDP funding. Ultimately, Congress provided significant increases for Fiscal Years 18 and 19, which will continue to benefit T1D research as well as many other fields of research.
- In March, 180 JDRF advocates from all 50 states traveled to the U.S. Capitol for Government Day to thank Congress for renewing SDP. Many of those who came to Washington, D.C., participated in SDP-funded clinical trials around the country, including studies that screen for autoantibodies that are markers of T1D.
- In May, JDRF announced it was partnering with the National Institutes of Health as part of the All of Us Research Program to gather health information from more than a million Americans to accelerate precision medicine research and medical breakthroughs. The data gathered may be used in critical T1D research that supports JDRF’s mission.
Ensuring Regulatory Frameworks that Promote Innovation
In 2018, years of extensive advocacy work by JDRF volunteers, staff, partners and others in the T1D community resulted in several significant regulatory accomplishments:
- The FDA announced its clearance of the Dexcom G6, which is the first continuous glucose monitor (CGM) to be interoperable, meaning it can be used with various insulin pumps and artificial pancreas (AP) algorithms. This was particularly important for JDRF’s Open Protocol initiative, which aims to have insulin pumps and CGMs “talk” to each other, regardless of whether they have the same manufacturer.
- Expanded approval of the MiniMed 670G hybrid closed-looped system in children between the ages 7 and 13, offering new access to younger children for the first time. JDRF was pivotal in galvanizing the AP field, working closely with numerous partners, researchers and companies to move the technology forward.
- The Eversense CGM system for use in people 18 and older became the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, providing multiple choices for people with T1D for which JDRF has long advocated. JDRF provided funding in the system’s early development stage.
- Another approval success was theTandem Diabetes Care®, Inc. t:slim X2™ Insulin Pump with Basal-IQ™ technology, a predictive low glucose suspend feature designed to reduce the frequency and duration of hypoglycemia. This is the first automated insulin delivery system approved for use by children as young as 6 years old, and the first insulin pump designated as compatible with integrated CGM devices.
- Approval for Insulet’s DASH Personal Diabetes Manager (PDM) handheld, Bluetooth-enabled tubeless pod and paired user/caregiver mobile apps. Those who use Omnipod’s PDM will now be able to control the insulin pump with functions that include taking a mealtime bolus and programming basal rates from the touchscreen device.
- As part of its Open Protocol initiative, JDRF continues to work with the FDA to further establish regulatory and legal frameworks to enable interoperable automated insulin delivery systems. In April, JDRF and The Leona M. and Harry B. Helmsley Charitable Trust hosted a public workshop which brought numerous stakeholders together to address challenges and plan next steps.
Promoting Access to T1D Therapies & Technologies
- JDRF continues to be deeply involved in advocacy to government, industry, insurers and employers to lower out-of-pocket insulin costs through its Coverage2Control campaign. In addition to urging manufacturers to do more to ensure affordable insulin, in November, JDRF directly contacted 23 of the nation’s 25 largest health insurance plans to encourage them pass savings from drug rebates through to consumers at the point of sale when they purchase insulin, as Aetna and UnitedHealthcare already do.
- Through Coverage2Control, JDRF engaged the T1D community to take action by writing their health insurance provider, urging them to pass drug savings they receive on to their members to help make insulin more affordable. JDRF also launched a survey as part of its efforts to connect with large employers to talk about how they can provide coverage that works for employees with T1D and their families.
- Additional work to address access to affordable insulin included calling upon federal officials to take action, submitting formal comments to the Centers for Medicare & Medicaid Services (CMS) in January to encourage them to pass rebates received by Medicare drug plans at the point of sale. In April, JDRF met with the U.S. Department of Health and Human Services (HHS) Deputy Secretary Eric Hargan to discuss how the government can address the cost of prescription drugs. In May, JDRF advocates met with Deputy Secretary Hargan and President Trump at the White House, where they discussed the President’s insurance pricing blueprint. In July, JDRF volunteers stormed Capitol Hill and urged members of Congress to make reducing out-of-pocket insulin costs a priority, and JDRF followed up with HHS, asking to pass rebates on to consumers. JDRF also expressed concerns that moving insulin from Part B to Part D of Medicare would raise insulin costs for beneficiaries, and provided written comments to the Administration’s blueprint to lower drug prices.
- After extensive advocacy by manufacturers and the diabetes community, including JDRF, CMS updated its coverage policy to reimburse CGM platforms that enable Medicare beneficiaries with T1D to share data through a smart device. This change supports the use of CGMs in conjunction with a smart device, including the important data sharing function they provide for patients and their families, a key safety feature.
- JDRF continues to advocate for Medicare coverage for AP systems, and worked with more than 240 U.S. Senators and Representatives to sign onto letters to the CMS Administrator on this topic, led by the Senate Diabetes Caucus and the Congressional Diabetes Caucus.
- JDRF will build on successes in other autoimmune diseases and the exciting insights coming from cancer immunotherapies to advance novel, disease-modifying approaches for T1D.
- JDRF will continue to form collaborations with other autoimmune groups and cancer immunotherapy groups to gain insights into the mechanisms, susceptibility factors and triggers driving the development of autoimmunity and ultimately accelerating the testing and approval of immune therapies for T1D.
- JDRF will leverage new mechanisms identified for protection of beta cell function as well as emerging pathways for regeneration of new beta cells.
- JDRF will continue to build on success in islet transplantation to engineer replenishable insulin producing cells from humans and other sources without the need for chronic broad-based immunosuppression.
- JDRF will leverage evolving tools in gene editing and gene therapy for future development of ‘designer’ beta cells for replacement therapy.
- JDRF will continue iterative improvements in AP components and automated systems with increased functionality and reduced individual burden.
- JDRF will support the development, regulatory and liability framework, and business model for open access integrated devices and algorithms, providing choices and better outcomes for people with T1D.
- JDRF will support the development and safe and effective use of non-insulin adjunctive treatments for improved glucose control and overall metabolic balance, without increasing individual burden. This includes the upcoming FDA decision on the second non-insulin glucose lowering therapy for T1D.
- JDRF will also support the development of next generation ‘designer’ insulins with targeted profiles such as glucose-responsiveness or liver-specific.
Advocacy: The tenets of JDRF’s Advocacy Agenda will continue to serve as a basis for JDRF’s evolving advocacy efforts in 2019.
- The Special Diabetes Program has led to scientific breakthroughs, new therapies, innovation on the next-generation of technology, and progress toward a cure. JDRF will continue to push for federal commitment to prioritize T1D research, concentrating on its long-term renewal, which expires Sept. 30, 2019. That includes meeting with members of Congress, including those newly elected, to build strong bipartisan support. We will advocate in person this spring at Government Day, when JDRF advocates will travel to Washington, D.C., to hold 500-plus meetings with members of Congress. Then in July, more than 160 children living with T1D will gather in the nation’s capital for JDRF’s Children’s Congress, where they will share personal stories with representatives from the U.S. House and Senate.
- JDRF will continue to demand increased access and adoption of T1D therapies, which includes making insulin more affordable. Ultimately, we believe the use of rebates should be eliminated from the drug distribution and coverage system. JDRF’s Coverage2Control campaign will continue to push insurers and employers to share rebates, include insulin as a preventative medicine, move insulin to tier 1 or tier 2 benefit levels, and provide cost-sharing as fixed dollar “co-payments.” JDRF will also advocate for coverage of current AP systems as well as future systems by private plans as well as Medicare.
- JDRF will also support improved prospects for regulatory approval of T1D therapies, including achieving new regulatory milestones. We will work to create frameworks that accelerate approval of T1D therapies, such as utilizing outcomes beyond HbA1C in regulatory decision-making and taking steps towards qualification of biomarkers to help accelerate research and development of T1D prevention therapies.
- JDRF advocates strongly for preserving protections for people with pre-existing health conditions, and in 2019, will oppose legislation that undermines access to comprehensive health insurance at rates similar to counterparts without pre-existing conditions.
It has been another hugely exciting year for T1International.
- Early in 2018, advocates held meetings in New York and Cincinnati to kick of state-level advocacy for transparency lower insulin prices.
- The Cincinnati meeting resulted in the formation of the incredible KOI#insulin4all Chapter who have achieved so much in a very short time, including ensuring that the insulin price crisis is a top priority for the Kentucky Diabetes Medical Emergency Response Task Force.
- Later in the year, we saw the launch of Chapters in Oklahoma, Pennsylvania, Illinois and Colorado.
- We provided one-on-one intensive training sessions to advocates in the USA, Ghana, Germany, Kenya, Bolivia, Uganda, Indonesia, Pakistan, Ecuador, and Costa Rica. All of them are carrying out detailed advocacy plans to improve the lives of people with type 1 diabetes in their countries and receiving ongoing guidance and support from T1International.
- In July, our leader Elizabeth Rowley joined the League of Diathletes – advocates with type 1 diabetes from 10+ countries – in London to deliver an advocacy session.
- In August we had our first full, multi-day advocacy training workshop in Accra, Ghana. In partnership with the Sonia Nabeta Foundation, we brought twelve advocates from five African countries together for an intensive two-day training session. Next year, we hope to bring these advocates together again to further their plans and enable them to train the next cohort of Pamojan advocates.
- Along with other advocates, we represented #insulin4all at the Affordable Meds Now Conference, where Elizabeth read Nicole’s powerful statement.
- Our Charity Ambassador Nicole Smith-Holt was a powerhouse advocate throughout the year, especially in May when T1I supported her to hold a press conference outside the Eli Lilly shareholder meeting.
- T1International held our 2nd annual Eli Lilly demonstration with partners People of Faith for Access to Medicines. There were multiple documentary film crews on site, as well as many media outlets including TV, Radio, and online press. Powerful imagery from the day was shared thousands of times and covered by local and national outlets.
- We’ve held other meetings, provided high-level testimony, created new resources, covered issues in new countries, been featured as Price fighting Heroes, and we are a partner in the exciting OPEN Project, adding a global access and affordability perspective to an exploration of DIY technology.
The insulin price crisis continues to be at the forefront of national and global conversations and we are seeing moves at many levels to lower drug prices. We are proud that so much of our advocacy is behind this progress.
The T1International Board of Trustees met in November to plan head and work to ensure ever-more ambitious outcomes. We have made a commitment to continue our truly global focus and to keep our laser-focus on our vision and mission. We have released our next organizational strategy, which we are excited to share, and are thrilled to be recruiting for a USA Program Manager.
* Thank You to all these orgs for the huge effort they put in on the part of patients. Here’s to an impactful new year in 2019! *