Department of Health and Human Services
December 04, 2013
December 04, 2013
SBIR / 2014
March 14, 2014
NOTE: The Solicitations and topics listed on this site are copies from the various SBIR agency solicitations and are not necessarily the latest and most up-to-date. For this reason, you should use the agency link listed below which will take you directly to the appropriate agency server where you can read the official version of this solicitation and download the appropriate forms and rules.
The official link for this solicitation is: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-028.html
Type 1 diabetes (T1D) results from the autoimmune destruction of the insulin-producing cells of the pancreatic islets of Langerhans and affects more than one million Americans, usually with onset in childhood or young adulthood. The disease markedly impairs quality of life and shortens lifespan primarily through premature mortality. T1D is associated with numerous complications including blindness, renal failure, painful nerve disorders, and amputation. In addition to its devastating toll in human suffering, T1D and its complications result in significant health care expenditures for families and constitute a major societal economic burden.
Clinical Trials have demonstrated significant reductions in complications of T1D through intensive control of blood glucose levels. However, 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 T1D cannot achieve optimal glycemic control despite enormous efforts. Compounding this difficulty is the trade-off between improved glycemic control and an increased risk for potentially life-threatening hypoglycemia.
A viable option for the treatment of diabetes is a system (artificial pancreas or closed-loop) that can mimic normal pancreatic beta cell function thereby restoring normal metabolic homeostasis without causing hypoglycemia. However, there are important technological obstacles such as glucose-sensing inaccuracies, imperfect algorithms for calculating the appropriate dose of insulin/glucagon taking into consideration diet and physical activity, insulin pumps’ mechanical problems, time delay from subcutaneous insulin infusion to pharmacologic effect, biocompatibility issues and data transmission, inter-device communication deficiencies that need to be resolved through the development of new technologies that may lead to integrated/automated devices. The ultimate research goal would be the development of mechanical or bio-artificial systems that may improve metabolic control and decrease glycemic excursions robustly preventing hypoglycemic episodes.
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 an integrated, long term, automated, wearable, glucose regulated insulin/pancreatic hormone delivery closed loop system. This announcement has two main purposes: a) promote technical innovation and b) pre-clinical or clinical testing of single or combined components of a closed loop system. Examples of projects that this announcement intends to attract include but are not limited to:
1. Glucose sensors and pancreatic hormones delivery systems:
2. Algorithms and Integrated Systems:
3. Pre-Clinical and Clinical Topics: