Support for Small Business Innovation Research (SBIR) to Develop New Technologies for Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R43/R44 Clinical Trial Not Allowed)

Despite the availability of increasingly effective treatment modalities, including insulin analogues, continuous glucose monitors (CGMs), and continuous subcutaneous insulin infusion (CSII) devices, a substantial proportion of patients with type 1 diabetes (T1D) cannot achieve adequate glycemic control and avoid acute complications such as hypoglycemia. NIDDK has long supported this area of research, especially through small business projects, and this support has contributed substantially to the development of new devices that are increasingly used in clinical practice. Nonetheless, the approved devices and current technologies still have significant limitations, and it is important to put renewed emphasis on the creation of a next generation of devices that will further the goals of relieving patients of the burden of diabetes self-management and achieving daily euglycemia to prevent acute and chronic complications. Several relevant projects have been supported because of the release of similar FOAs in the recent past. However, given the pace of technical progress in this field and the substantial room for improvement in reliability, accuracy, and patient burden of current devices, NIDDK considers it important to continue supporting research in this field. This FOA is intended to support cutting edge research conducted by small business leading to the development of innovative technologies that may advance progress toward integrated, long term, wearable/implantable, glucose regulated open and closed loop insulin/pancreatic hormone delivery systems. This announcement has two main purposes: a) to promote technical innovation and b) to conduct pre-clinical testing of single or combined components of open and closed loop systems. Research topics that this announcement intends to attract include but are not limited to: 1. Glucose sensors and pancreatic hormones delivery systems: Novel, accurate, reliable and user-friendly sensor technologies for glucose and other metabolically relevant signals/analytes to optimize open and closed loop diabetes management. Development of new miniaturized, implantable or minimally invasive continuous glucose sensors with long functional life (at least 4 weeks), real time measurement, no or minimal need of recalibration, easily implanted and replaced, unobtrusive to the user and accurate at all ranges of glycemia. Novel technologies for prediction and accurate detection of hypoglycemia (