Statement from Aaron J. Kowalski, Ph.D., President and CEO of JDRF, on the U.S. Food and Drug Administration (FDA) authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system
NEW YORK, Dec. 13, 2019 /PRNewswire/ -- "Regulatory authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system is a huge win for the type 1 diabetes (T1D) community and a critical step forward in making day-to-day life better for people living with the disease.
As part of our mission to improve the lives of those affected by T1D, JDRF has been a leader in artificial pancreas (AP) research for more than 15 years and partnered with the U.S. Food and Drug Administration (FDA) to establish regulatory pathways to ensure AP technology gets into the hands of people with T1D as quickly as possible.
This is the second hybrid closed-loop system on the market and the first algorithm authorized as an interoperable automated glycemic controller, which means it could be a component of an open-protocol system. People with different devices could use the algorithm and manage their glucose levels in a way that works best for them. JDRF research grants supported the development of this algorithm, and our advocacy supported the Special Diabetes Program, which funded its clinical testing.
Until we find cures, we are continuing to support the development of new technologies and treatments to improve blood sugar management so people with T1D can live healthier and more manageable lives. JDRF is also fighting to ensure people with this disease have more choices and better access to the diabetes management tools that work best for them through our Coverage2Control campaign. Today's announcement is yet another reason why health plans should cover all FDA authorized diabetes management tools, to help people with T1D manage this life-threatening disease. In particular, JDRF calls upon UnitedHealthcare to lift its restrictions which limit options of insulin pumps available to its members."
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.