Quantitative Biomarkers of T1D Peripheral Neuropathy using Functional Imaging

摘要 该项目的目标是验证i-RxTherm™，这是VisionQuest的专利功能 产生生物标志物的热成像系统，用于糖尿病外周的早期检测 神经病(DPN)。这种装置是基于微血管功能改变的原理 与神经功能的可量化变化相关，如可测量的 微血管改变。 据估计，全世界有4.15亿人患有糖尿病，其中包括2900多万人 美国人。糖尿病患者面临着一系列并发症的风险，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)。15%的糖尿病患者会因以下原因而发展为足部溃疡 在他们有生之年的周围神经病。足部溃疡是低血压的主要原因(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™。第一阶段结果 证明了I-RxTherm™产生了生物标记物来检测糖尿病周围神经病变的早期迹象。我们的 结果表明，I-RxTherm™可以区分正常对照组和高血压患者。 DPN具有较高的敏感性和特异性。此外，我们还证明了I-RxTherm™ 确诊的糖尿病患者，未被诊断为DPN，但后来确诊为 早期至中度的DPN征象。在这个项目的第二阶段，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，可以用于 初级保健机构。 在这项赠款申请中，有三个具体目标需要实现。第一个目标是 识别和量化反映DPN严重程度或分期的特定生物标志物。要做到这一点 目的收集包括正常人和患者在内的136名受试者的数据。 被诊断为DPN。第二个目标是收集240名糖尿病患者的数据 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症状，但尚未出现 之前被诊断出患有这种疾病。在最终目标中，我们将开发和测试一个低成本版本 可以在初级护理环境中使用的I-RxTherm™。在这个项目结束时，我们将 拥有经过充分验证的设备，可提供更有效的筛查和早期 DPN的检测。

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.