Software for Early Detection of Diabetic Neuropathy

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DESCRIPTION (provided by applicant): The main objective of this SBIR Phase I research is to develop and test a software prototype. The prototype will lead to a software product. It will be a clinical tool that helps clinicians to assess the condition of patients who are at risk of or who have diabetic neuropathy. The software will analyze optically sectioned images of subbasal nerve fiber layers in the cornea. Collaborators have seen a clear structural difference in the nerve fibers when diabetic neuropathy is present or progresses. These structural changes will help detect that a patient is at risk or developing the condition, before symptoms occur, or that the condition is stabilized or worsening. Typically the software will be utilized following standard clinical examination that includes neurological tests, to confirm suspicions or findings arising during the examination. Information that the software will provide includes statistical summaries of the quantified shapes of the nerve fibers. These data will be presented in a report that is efficient and easy to use in the clinic. Preliminary data produced by our collaborators indicate that the density, length and other measures change with the condition. The Phase I project will build a first prototype and show feasibility of developing a software product for the clinic. The Phase II project will build a refined prototype and carry out further testing, making it ready for integration into a product. The end product will have 3 general purposes: (1), for confirming or corroborating assessment from clinical examination, (2) screening at-risk patients, and (3), following patients who are developing diabetic neuropathy. The first purpose, (1), will, in many cases, replace the more invasive electromyography (EMG) procedure which is uncomfortable to patients, and in some cases serve as an adjunct or precursory test to EMG. Because it carries less risk and discomfort compared to EMG, it is expected that physicians will be more aggressive to order the tests to screen for or rule out diabetic neuropathy. The specific aims are: (1) Design and implement algorithms for counting and measuring nerve endings in the cornea. (2) Prototype software that provides statistical summaries of these measurements. (3) Test the software by showing a correlation (by regression analysis) between these measures and the clinical assessment of a group of cases that are recorded in an existing database. PUBLIC HEALTH RELEVANCE The project will lead to a software product that helps to diagnose and monitor patients who are at risk of or have diabetic neuropathy. The end product will have 3 general purposes: (1), for confirming a diagnosis, (2) Screening at-risk subjects, and (3), following subjects who are developing diabetic neuropathy. The 1st purpose will, in many cases, replace the more invasive EMG procedure which is uncomfortable to patients.