Will Create FDA-regulated App in App Store, Advance Interoperability
NEW YORK and PALO ALTO, Calif., – The Leona M. and Harry B. Helmsley Charitable Trust and JDRF today announced a collaborative grant agreement to provide Tidepool, a California nonprofit software organization, with the initial funding it needs to begin developing Tidepool Loop, a hybrid closed loop automated insulin delivery app, for the iOS App Store as an FDA-regulated mobile application.
Through this partnership, The Helmsley Charitable Trust and JDRF will provide Tidepool with funds to expand its software development and customer support operation. Tidepool intends to deliver Tidepool Loop as an FDA-regulated app in the iOS App Store. Tidepool Loop is intended to work with multiple insulin pumps and continuous glucose monitoring devices. [Read more about Tidepool Loop here.]
People with type 1 diabetes have to continually check their blood glucose levels and are dependent on injected or pumped insulin to survive. Automated insulin delivery systems monitor blood-glucose levels and use an algorithm to automatically provide the right amount of insulin at the right time. This helps keep people with type 1 diabetes in a normal blood-glucose range, resulting in less stress and safer outcomes.
“Loop is one of the greatest things out there right now,” said David Panzirer, trustee of The Helmsley Charitable Trust. “My daughter has been on [DIY] Loop for nearly two years. There have definitely been improvements in her clinical care, but the real story is the improvement in her quality of life. My daughter tells me that she doesn’t need to think about her diabetes as much as she used to.”
“This is exactly what we dreamed of when we launched the JDRF Open Protocol Initiative in 2017 – to accelerate innovation, give users greater control over insulin delivery devices, and expand their ability to choose system components that work best for them,” said Dr. Aaron Kowalski, Chief Mission Officer for JDRF. “Through the Tidepool Loop project, Tidepool will demonstrate the power and value of an interoperable ecosystem of diabetes devices, giving people with diabetes more options for better control with less burden.”
“Tidepool’s mission has always been to build and deliver ground-breaking software that helps people living with diabetes,” said Howard Look, founder and CEO of Tidepool. “With Tidepool Loop, we are building upon the incredible efforts and innovation of the #WeAreNotWaiting movement, including the work of Nate Racklyeft, Pete Schwamb, Ben West, and Katie DiSimone. By taking on Tidepool Loop, we will bring Loop to an even a broader community, make it work with commercial, in-warranty devices, and deliver it through FDA pathways.”
“The Helmsley Charitable Trust is very supportive of this effort,” Panzirer continued. “As a non-profit, and a participant in the FDA PreCertification Pilot Program, Tidepool is in a unique position to bring Loop to the FDA, and to make sure it works with commercially available insulin pumps. By working openly and transparently, Tidepool will also lay the groundwork for future interoperable, closed loop submissions.”
“We’ve made such progress in the last decade accelerating the availability of technologies to help people with T1D live healthier lives, but we have more to do,” said Kowalski. “JDRF is thrilled to be partnering with The Helmsley Charitable Trust to fund Tidepool to bring this innovation to the broader community.”
“Eleven Tidepool employees are also using [DIY] Loop for themselves or their children living with type 1 diabetes, including my daughter,” said Look. “We are incredibly thankful for The Helmsley Charitable Trust and JDRF for kicking off this incredible partnership, and also to the device makers who are stepping up to be a part of this groundbreaking work.”
An observational study funded by The Helmsley Charitable Trust of current [DIY] Loop users will be conducted by the Jaeb Center for Health Research. Recruitment for this study is expected to begin in early 2019.
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning its active grantmaking in 2008, Helmsley has committed more than $2 billion for a wide range of charitable purposes. For more information, please visit www.helmsleytrust.org.
Tidepool is a 501(c)(3) nonprofit organization with the mission of making diabetes data more accessible, actionable, and meaningful by liberating data from diabetes devices, supporting researchers, and providing great, free software to the entire diabetes community, including people living with diabetes and their healthcare providers.
Tidepool currently provides software to help import, manage, store, and gain insights from diabetes device data. Tidepool’s software and HIPAA-compliant data services are provided for free to end users and clinicians including: Tidepool Web, Tidepool Uploader, TIdepool Mobile, and the Tidepool Platform.
Through the Tidepool Clinical Study Platform and the Tidepool Big Data Donation Project, Tidepool is empowering the next generation of diabetes research and innovation.
Tidepool Loop is a project to build and support an FDA-regulated version of Loop, to be available in the iOS App Store, intended to work with commercially available insulin pumps and CGMs.
Carey Meyers, The Helmsley Charitable Trust, CMeyers@helmsleytrust.org
C.J. Volpe, JDRF, CVolpe@jdrf.org
Christopher Snider, Tidepool, christopher@tidepool.org
