Special Diabetes Program Reauthorization Act of 2023

Madam President, I rise today to introduce the Special Diabetes Program Reauthorization Act of 2023 with Senator Jeanne Shaheen, my colleague from New Hampshire and cochair of the Senate Diabetes Caucus. Our bipartisan bill would reauthorize and strengthen vital type 1 diabetes research happening at the National Institutes of Health and renew critical treatment, education, and prevention programs for at-risk populations, specifically Native American and Alaska Native communities, who experience type 2 diabetes at nearly three times the national average. Together, these programs have become the Nation's most strategic and effective effort to combat diabetes and its complications, but, without an extension, both programs are at risk of expiring on September 30, 2023.

For more than 25 years, the Special Diabetes Program--comprised of the Special Statutory Funding Program for Type 1 Diabetes Research and the Special Diabetes Program for Indians, SDPI--has delivered meaningful resources and research breakthroughs for those with type 1 diabetes and also for Native Americans and Alaska Natives. This research has also led to advancements to the broader community, including the 37 million Americans with diabetes and 96 million with prediabetes. Our bill would continue these investments in the research aimed at developing a cure for diabetes and support the programs that help prevent and treat the disease and its complications.

In one of my very first meetings as a new Senator, I met a young Mainer with type 1 diabetes. I will never forget this 10-year-old boy looking up at me and telling me that he wished he could take just 1 day off from having diabetes--his birthday or Christmas--but of course he could not. This meeting led me to start the bipartisan Senate Diabetes Caucus and to begin fighting for a cure for this devastating disease.

Since then, we have made tremendous progress thanks to investments like the Special Diabetes Program. From new technologies that are making these children's lives easier to manage to treatments that can potentially delay the clinical diagnosis of type 1 diabetes, this program has generated a strong return on investment. Renewal of the SDP is absolutely critical to accelerating the progress we have made over the past two decades to treat and one day cure type 1 diabetes. Today's research represents tomorrow's cure.

As the cochairs of the Senate Diabetes Caucus, Senator Shaheen and I recently led a letter signed by 60 Senators advocating for the program's reauthorization and outlining why investing in the Special Diabetes Program is a cost-effective investment toward improving lives and reducing healthcare expenditures. The driving force behind this program is curing one of the United States' most costly diseases in both human and economic terms.

Our bill would reauthorize both components of the SDP through December 2025 at an annual funding level of $170 million per program. Congress has reauthorized the SDP with bipartisan support numerous times since the program's inception in 1997. Yet funding has not increased since fiscal year 2004. During this time period, the cost of research has increased, as has the size of the Indian Health Service population and the cost of medical care. For that

reason, our bill also proposes a $20 million increase per program. This would be the first increase for this program in 20 years.

The two programs in this reauthorization bill have had transformative effects on diabetes care. The first program is the Special Statutory Funding Program for Type 1 Diabetes Research, which provides funds to NIH's National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK, for life-changing preventive diabetes research. For example, SDP-funded research laid early groundwork for artificial pancreas, AP, systems--or closed-loop ``all-in-one'' diabetes management systems-- that have shown great promise in improving glucose monitoring and insulin delivery. Advances in technology have helped reduce costly and burdensome complications and improved the quality of life for those with the disease. There are now multiple FDA-approved artificial pancreas systems, enabling individuals with type 1 diabetes and their doctors to choose the system that works best for them. According to one study, the use of AP systems in adults could save Medicare roughly $1 billion over 25 years.

SDP research has also helped researchers identify genes and environmental factors linked with type 1 diabetes, led to changes in clinical practice guidelines for diabetic eye care, and supported clinical trials on therapeutics to prevent and treat the disease. For example, landmark research conducted by SDP-funded TrialNet demonstrated for the first time ever that early preventive treatment with a drug targeting the immune system delayed onset of clinical-type 1 diabetes for 2 years. This drug has since been approved by the FDA and is the first ever disease modifying therapy for type 1 diabetes.

Continued investment in this program is essential to continue large- scale trials, plan next steps for research programs, conduct outreach and education, and allocate research resources effectively. As Dr. Griffin Rodgers, Director of the NIDDK, said when testifying at a Senate Aging Committee hearing I chaired in 2019, ``with continued research, it is possible to imagine that people could lead a life free of the burden of Type 1 diabetes and its complications.''

Our bill would also provide $170 million per year to sustain a second program, the Special Diabetes Program for Indians, SDPI. SDPI supports type 2 diabetes treatment and prevention strategies for Native American and Alaska Native populations who are disproportionately burdened with type 2 diabetes at a rate of nearly three times the national average. In Maine this program benefits five Tribal communities across the state, providing approximately 5 million dollars in support for diabetes prevention activities in those Tribal populations. This Federal support is critical to reducing disparities. As Chief William Nicholas of the Passamaquoddy Tribe in Maine recently explained, ``Special Diabetes Program funding is instrumental and necessary to educate and address high rates of diabetes in Indian Country. Native Americans are high risk for diabetes, and the funding will continue the much-needed support, education, and treatment in our communities.''

Tremendous improvements are occurring in diabetes outcomes for Alaska Natives and Native Americans, and the SDPI has played a key role, just as Congress envisioned when the program was created. Although diabetes rates among the IHS service population remain high, with the help of this program, diabetes rates in youth in these communities have not increased in more than 10 years, and diabetes rates in Alaska Native and Native American adults have not increased since 2011. Communities with SDPI-funded programs have actually seen the diabetes incidence rate decrease consistently since 2013.

The program is effective by other measures as well. Since SDPI began, there has been a 50-percent reduction in diabetic eye disease rates among Alaska Natives and Native Americans; hospitalizations for uncontrolled diabetes among Alaska Native and Native American adults have dropped by 84 percent; and the rate of end-stage renal disease has fallen by more than 50 percent. These positive clinical outcomes have reduced the risk for blindness, amputations, and kidney failure, in addition to preventing the onset of type 2 diabetes.

The Special Diabetes Program is funding research that is leading directly to the development of new insights and therapies that are improving the lives of those with diabetes and accelerating progress toward curing and preventing the disease. Ruby Anderson, a young Mainer with type I diabetes who testified before the 2019 JDRF Children's Congress, put an even finer point on the need to reauthorize the SDP. Ruby she said she doesn't want her brother or sister to have to go through what she has experienced. As she told Senators, ``We need more research to find a cure. We need even better devices. And we need to figure out what causes TID so we can stop it.''

I couldn't agree more with Ruby, and I am confident the Special Diabetes Program will make these objectives possible. I urge my colleagues to support a multi-year extension of this important program so that one day we will find a cure to this debilitating disease.

Madam President, I rise today to introduce the Special Diabetes Program Reauthorization Act of 2023 with Senator Jeanne Shaheen, my colleague from New Hampshire and cochair of the Senate Diabetes Caucus. Our bipartisan bill would reauthorize and strengthen vital type 1 diabetes research happening at the National Institutes of Health and renew critical treatment, education, and prevention programs for at-risk populations, specifically Native American and Alaska Native communities, who experience type 2 diabetes at nearly three times the national average. Together, these programs have become the Nation's most strategic and effective effort to combat diabetes and its complications, but, without an extension, both programs are at risk of expiring on September 30, 2023.

For more than 25 years, the Special Diabetes Program--comprised of the Special Statutory Funding Program for Type 1 Diabetes Research and the Special Diabetes Program for Indians, SDPI--has delivered meaningful resources and research breakthroughs for those with type 1 diabetes and also for Native Americans and Alaska Natives. This research has also led to advancements to the broader community, including the 37 million Americans with diabetes and 96 million with prediabetes. Our bill would continue these investments in the research aimed at developing a cure for diabetes and support the programs that help prevent and treat the disease and its complications.

In one of my very first meetings as a new Senator, I met a young Mainer with type 1 diabetes. I will never forget this 10-year-old boy looking up at me and telling me that he wished he could take just 1 day off from having diabetes--his birthday or Christmas--but of course he could not. This meeting led me to start the bipartisan Senate Diabetes Caucus and to begin fighting for a cure for this devastating disease.

Since then, we have made tremendous progress thanks to investments like the Special Diabetes Program. From new technologies that are making these children's lives easier to manage to treatments that can potentially delay the clinical diagnosis of type 1 diabetes, this program has generated a strong return on investment. Renewal of the SDP is absolutely critical to accelerating the progress we have made over the past two decades to treat and one day cure type 1 diabetes. Today's research represents tomorrow's cure.

As the cochairs of the Senate Diabetes Caucus, Senator Shaheen and I recently led a letter signed by 60 Senators advocating for the program's reauthorization and outlining why investing in the Special Diabetes Program is a cost-effective investment toward improving lives and reducing healthcare expenditures. The driving force behind this program is curing one of the United States' most costly diseases in both human and economic terms.

Our bill would reauthorize both components of the SDP through December 2025 at an annual funding level of $170 million per program. Congress has reauthorized the SDP with bipartisan support numerous times since the program's inception in 1997. Yet funding has not increased since fiscal year 2004. During this time period, the cost of research has increased, as has the size of the Indian Health Service population and the cost of medical care. For that

reason, our bill also proposes a $20 million increase per program. This would be the first increase for this program in 20 years.

The two programs in this reauthorization bill have had transformative effects on diabetes care. The first program is the Special Statutory Funding Program for Type 1 Diabetes Research, which provides funds to NIH's National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK, for life-changing preventive diabetes research. For example, SDP-funded research laid early groundwork for artificial pancreas, AP, systems--or closed-loop ``all-in-one'' diabetes management systems-- that have shown great promise in improving glucose monitoring and insulin delivery. Advances in technology have helped reduce costly and burdensome complications and improved the quality of life for those with the disease. There are now multiple FDA-approved artificial pancreas systems, enabling individuals with type 1 diabetes and their doctors to choose the system that works best for them. According to one study, the use of AP systems in adults could save Medicare roughly $1 billion over 25 years.

SDP research has also helped researchers identify genes and environmental factors linked with type 1 diabetes, led to changes in clinical practice guidelines for diabetic eye care, and supported clinical trials on therapeutics to prevent and treat the disease. For example, landmark research conducted by SDP-funded TrialNet demonstrated for the first time ever that early preventive treatment with a drug targeting the immune system delayed onset of clinical-type 1 diabetes for 2 years. This drug has since been approved by the FDA and is the first ever disease modifying therapy for type 1 diabetes.

Continued investment in this program is essential to continue large- scale trials, plan next steps for research programs, conduct outreach and education, and allocate research resources effectively. As Dr. Griffin Rodgers, Director of the NIDDK, said when testifying at a Senate Aging Committee hearing I chaired in 2019, ``with continued research, it is possible to imagine that people could lead a life free of the burden of Type 1 diabetes and its complications.''

Our bill would also provide $170 million per year to sustain a second program, the Special Diabetes Program for Indians, SDPI. SDPI supports type 2 diabetes treatment and prevention strategies for Native American and Alaska Native populations who are disproportionately burdened with type 2 diabetes at a rate of nearly three times the national average. In Maine this program benefits five Tribal communities across the state, providing approximately 5 million dollars in support for diabetes prevention activities in those Tribal populations. This Federal support is critical to reducing disparities. As Chief William Nicholas of the Passamaquoddy Tribe in Maine recently explained, ``Special Diabetes Program funding is instrumental and necessary to educate and address high rates of diabetes in Indian Country. Native Americans are high risk for diabetes, and the funding will continue the much-needed support, education, and treatment in our communities.''

Tremendous improvements are occurring in diabetes outcomes for Alaska Natives and Native Americans, and the SDPI has played a key role, just as Congress envisioned when the program was created. Although diabetes rates among the IHS service population remain high, with the help of this program, diabetes rates in youth in these communities have not increased in more than 10 years, and diabetes rates in Alaska Native and Native American adults have not increased since 2011. Communities with SDPI-funded programs have actually seen the diabetes incidence rate decrease consistently since 2013.

The program is effective by other measures as well. Since SDPI began, there has been a 50-percent reduction in diabetic eye disease rates among Alaska Natives and Native Americans; hospitalizations for uncontrolled diabetes among Alaska Native and Native American adults have dropped by 84 percent; and the rate of end-stage renal disease has fallen by more than 50 percent. These positive clinical outcomes have reduced the risk for blindness, amputations, and kidney failure, in addition to preventing the onset of type 2 diabetes.

The Special Diabetes Program is funding research that is leading directly to the development of new insights and therapies that are improving the lives of those with diabetes and accelerating progress toward curing and preventing the disease. Ruby Anderson, a young Mainer with type I diabetes who testified before the 2019 JDRF Children's Congress, put an even finer point on the need to reauthorize the SDP. Ruby she said she doesn't want her brother or sister to have to go through what she has experienced. As she told Senators, ``We need more research to find a cure. We need even better devices. And we need to figure out what causes TID so we can stop it.''

I couldn't agree more with Ruby, and I am confident the Special Diabetes Program will make these objectives possible. I urge my colleagues to support a multi-year extension of this important program so that one day we will find a cure to this debilitating disease.

Madam President, I ask unanimous consent that the text of the bill be printed in the Record.