Software for Early Detection of Diabetic Neuropathy

早期检测糖尿病神经病变的软件

• 批准号: 7537009
• 负责人: TIMOTHY J HOLMES
• 金额: $ 22.05万
• 依托单位: LICKENBROCK TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7537009
• 关键词: Algorithms; Clinic; Clinical; Clinical assessments; Computer software; Condition; Cornea; Count; Data; Databases; Diabetic Neuropathies; Diagnosis; Early Diagnosis; Electromyography; Image; Invasive; Lead; Length; Measurement; Measures; Nerve Endings; Nerve Fibers; Neurologic; Neurologic Examination; Patient Monitoring; Patients; Phase; Physicians; Procedures; Public Health; Purpose; Records; Regression Analysis; Reporting; Research; Risk; Screening procedure; Severities; Shapes; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Symptoms; Testing; density; design; prototype; tool

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.

描述（由申请人提供）：SBIR 第一阶段研究的主要目标是开发和测试软件原型。原型将产生软件产品。它将成为一种临床工具，帮助临床医生评估有糖尿病神经病变风险或患有糖尿病神经病变的患者的状况。该软件将分析角膜基底神经纤维层的光学切片图像。合作者发现，当糖尿病神经病变存在或进展时，神经纤维存在明显的结构差异。这些结构变化将有助于在症状出现之前检测患者是否处于危险中或正在发展该疾病，或者病情稳定或恶化。通常，该软件将在包括神经学测试在内的标准临床检查后使用，以确认检查期间出现的怀疑或发现。该软件将提供的信息包括神经纤维量化形状的统计摘要。这些数据将在一份报告中呈现，该报告在临床上高效且易于使用。我们的合作者产生的初步数据表明，密度、长度和其他测量值会随着条件的变化而变化。第一阶段项目将构建第一个原型并展示为诊所开发软件产品的可行性。第二阶段项目将构建一个完善的原型并进行进一步的测试，为集成到产品中做好准备。最终产品将具有 3 个一般用途：(1) 用于确认或佐证临床检查的评估，(2) 筛查高危患者，(3) 跟踪正在发生糖尿病神经病变的患者。第一个目的 (1) 在许多情况下将取代对患者来说不舒服的更具侵入性的肌电图 (EMG) 程序，并且在某些情况下充当 EMG 的辅助或前期测试。由于与肌电图相比，它的风险和不适感更小，因此预计医生将更积极地进行检查以筛查或排除糖尿病神经病变。具体目标是：（1）设计和实现用于计数和测量角膜神经末梢的算法。 (2) 原型软件，提供这些测量的统计摘要。 (3) 通过显示这些测量值与现有数据库中记录的一组病例的临床评估之间的相关性（通过回归分析）来测试软件。公共健康相关性 该项目将推出一款软件产品，帮助诊断和监测有糖尿病神经病变风险或患有糖尿病神经病变的患者。最终产品将具有 3 个一般用途：(1) 用于确认诊断，(2) 筛查高危受试者，(3) 跟踪正在发生糖尿病神经病变的受试者。在许多情况下，第一个目的将取代对患者来说不舒服的更具侵入性的肌电图检查。