HHS SBIR PA-14-058

Diabetes markedly impairs quality of life and shortens lifespan primarily through premature cardiovascular mortality, neuropathy, nephropathy, retinopathy and wound healing compromise. Those complications lead to coronary, cerebral and peripheral artery disease, blindness, renal failure, impaired cognitive function, painful nerve disorders, diabetic foot ulcers and amputation. In addition to its devastating toll in human suffering, type 1 diabetes (T1D) and its complications result in significant health care expenditures for families and constitute a major societal economic burden. A critical barrier for developing therapies for diabetes complications is the paucity of validated biomarkers that can report early tissue damage before it is clinically apparent and at a stage where treatment may be more effective.  In addition, biomarkers are needed to measure an early response to an intervention and to serve as surrogate end-points for clinical outcomes that may take years to occur.  NIDDK has continuously funded research in this field along the years but new emphasis is needed for novel and more effective technologies based on current scientific advances that may be developed as commercial products by the biotech/small business sector.

The main goal of this Funding Opportunity Announcement (FOA) is to stimulate bioengineering, basic and translational researchers to develop novel assays/technologies for the early diagnosis, monitoring and treatment of the micro and macro vascular complications of diabetes. The research may include animal models of type 2 diabetes or subjects with type 2 diabetes if applicable to T1D.

Areas of research and development considered a priority on this field include but are not limited to:

• Development of measurement tools and or accurate biomarkers for early detection, diagnosis, and quantification of complications in T1D including cardiovascular disease, cardiomyopathy, peripheral and autonomic neuropathy, retinopathy and nephropathy.
• The development of methodologies or biomarkers to help understand the pathophysiology of T1D complications.
• Development of non-invasive or minimally invasive technologies to measure the blood vessels and nerves of the eye as markers for disease progression in the retina and tissues outside the eye.
• Application to diabetes complications of new retinal imaging systems that allow visualization at the molecular level to assess for damage from hyperglycemia  
• Application of basic research in regenerative medicine for the treatment of T1D complications.
• Development of better predictors of patients with diabetes most prone to accelerated development and progression of micro and macrovascular complications.
• Development of novel or improved therapeutics for the prevention and/or treatment of neurologic complications of T1D, including neuropathy, neuropathic pain, autonomic neuropathy and cognitive impairment.
• Novel imaging/non-invasive technologies to facilitate prediction of ulcer formation through the measurement of local tissue perfusion, oxygenation, hydration and signs of inflammation.
• New/improved technologies/biomaterials for the delivery of therapies to chronic diabetes wounds.
• The development of novel animal models more predictive of the human response for pre-clinical testing of therapies for diabetes
• Development of novel portable technologies for the ambulatory or at home treatment of diabetes complications