Clinical, Behavioral and Physiological Research Testing Current and Novel Closed Loop Systems (DP3)
“New technologies for monitoring blood glucose, which provide detailed information about daily glucose patterns, are already in clinical use and are steadily improving in terms of ease of use and accuracy, and, together with integrated insulin delivery systems, may represent the next generation in T1D management. Furthermore, telemedicine/mobile health platforms with remote monitoring capacity through portable miniaturized devices are quickly evolving. In addition to contributing to the daily management of blood glucose, these new technologies can also be used as tools to enhance understanding of the pathophysiology of glucose regulation in patients with type 1 diabetes, thus contributing to further enhancement of algorithms for closed loop systems and strategies to avoid hypoglycemia. It is also important to identify the most effective ways to incorporate these technologies into clinical care and how to enhance the “usability” of these new tools to help patients in their decision-making regarding diabetes control, without overwhelming them with excessive data volume or complexity. These emerging and next-generation technologies require further translational research to evaluate and improve their safety, accuracy, and efficacy as research progresses from animal and simulated models to human trials. It is therefore important to continue supporting collaborative research to clinically test current and new technologies in order to optimize their operability, taking into consideration patient preferences and behavioral and physiological factors, to achieve the goal of viable, functionally integrated, closed-loop systems for routine use.
This FOA (Funding Opportunity Announcement) encourages investigative teams to develop research projects applying diabetes technologies to improve clinical outcomes. Research is sought in three key areas: a) Clinical/behavioral research focused on enhancing the application of new technology for glucose sensing and insulin/pancreatic hormone delivery to improve glucose control and reduce hypoglycemia in patients with type 1 diabetes, b) Studies that use new technologies to better understand or improve physiological mechanisms affecting glucose control in type 1 diabetes, and c) Research to test and improve the efficacy, safety, accuracy and reliability of these new technologies in humans. Only human studies will be considered responsive to this FOA.”
A letter of intent is due by May 28th, 2016 and applications are due by June 28th, 2016 at 5 pm local time.
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