Quantitative Biomarkers of T1D Peripheral Neuropathy using Functional Imaging

总结 本项目的目的是验证i-RxTherm™，VisionQuest的专利功能 产生用于早期检测糖尿病外周血的生物标志物的热成像系统 神经病变（DPN）。这种装置是基于微血管功能变化的原理 与神经功能的可量化变化相关， 微血管改变 据估计，糖尿病影响着全球4.15亿人，其中包括2900多万人。 美国人糖尿病患者面临着各种并发症的风险，包括心脏病， 肾脏疾病（肾病）、眼部疾病（糖尿病视网膜病变）和糖尿病足 （周围神经病变）。百分之十五的糖尿病患者会发展为足部溃疡的结果， 周围神经病变在其一生中。足部溃疡是导致低血糖的主要原因（85%）。 糖尿病患者的肢体截肢。 在该项目的第一阶段，VisionQuest开发并测试了i-RxTherm™。I期结果 证明i-RxTherm™产生生物标志物以检测DPN的早期体征。我们 结果显示，i-RxTherm™可以区分正常对照和患有 DPN具有较高的敏感性和特异性。此外，我们证明了i-RxTherm™ 确定了未诊断为DPN但后来证实显示 早期至中度DPN体征。在本项目的第二阶段，我们的目标是验证这些结果 在更大的受试者队列中，并开发一种低成本的临床原型，可用于 初级保健设置。 有三个具体的目标要完成在这个赠款申请。第一个目标是 鉴定和量化DPN严重程度或阶段的特定生物标志物。实现这一 目的：我们将收集136名受试者的数据，包括正常对照和患者 诊断为DPN。第二个目标是收集240名糖尿病患者的数据， 未确诊的DPN，并证明我们的分类方法可以识别患者 糖尿病患者出现早期至中度DPN体征， 以前被诊断出患有这种疾病。在最终目标中，我们将开发和测试低成本版本 i-RxTherm™可用于初级保健环境。在这个项目结束时，我们将 有一个充分验证的设备，将提供一个更有效的手段，筛选和早期 检测DPN。

Summary The objective of this project is to validate the i-RxTherm™, VisionQuest’s patented functional thermal imaging system that produces biomarkers for early detection of diabetic peripheral neuropathy (DPN). This device is based on the principle that changes in microvascular function are correlated to quantifiable changes in nerve function as expressed in measureable microvascular changes. Diabetes affects an estimated 415 million people worldwide, including more than 29 million Americans. Diabetic patients are at risk for a wide array of complications, including heart disease, kidney disease (nephropathy), ocular diseases (diabetic retinopathy), and diabetic foot (peripheral neuropathy). Fifteen percent of diabetics will develop a foot ulcer as a result of peripheral neuropathy during their lifetime. Foot ulcers are the main cause (85%) of lower extremity amputation in patients with diabetes. In Phase I of this project VisionQuest developed and tested the i-RxTherm™. Phase I results demonstrated that the i-RxTherm™ produced biomarkers to detects early signs of DPN. Our results showed that the i-RxTherm™ can differentiate between normal controls and patients with DPN with high sensitivity and specificity. Furthermore, we demonstrated that the i-RxTherm™ identified diabetics who were undiagnosed with DPN but who were later confirmed to show early to moderate signs of DPN. In Phase II of this project, our objective is to validate these results in a larger cohort of subjects, and to develop a low-cost clinical prototype that can be used in the primary care setting. There are three specific aims to be accomplished in this grant application. The first aim is to identify and quantify specific biomarkers of levels of severity or stages of DPN. To achieve this aim we will collect data from 136 subjects that will include normal controls and patients diagnosed with DPN. The second aim is to collect data from 240 diabetics with previously undiagnosed DPN and to demonstrate that our classification methodologies identify patients with diabetes who present with early to moderate signs of DPN and who have not been previously diagnosed for the disease. In the final aim, we will develop and test a low-cost version of the i-RxTherm™ that can be used in the primary care setting. At the end of this project we will have a fully validated device that will provide a more effective means of screening and early detection of DPN.