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

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

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

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

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

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

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

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

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

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

What is the Charitable Giving Incentive?

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

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

What if I itemize my deductions?

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

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

What does this mean for corporations? 

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

Where can I find more information about this? 

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

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

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

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

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

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

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

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

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

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

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

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