Novel Home Care Device for High-Risk Diabetes Patients

针对高危糖尿病患者的新型家庭护理设备

• 批准号: 6583372
• 负责人: DAN R LANCTOT
• 金额: $ 10.07万
• 依托单位: DIABETICA SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-04-01 至 2004-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6583372
• 关键词: biomedical equipment development; clinical research; decubitus ulcer; diabetes risk; diabetic neuropathy; diagnosis design /evaluation; foot; home health care; human subject; joint disorder; noninvasive diagnosis; patient monitoring device; peripheral blood vessel disorder; skin disorder diagnosis; thermometry

DESCRIPTION (provided by applicant): We will fabricate and validate a home-based device (HealthScan) for diabetics at high risk for foot complications. This infrared step-on temperature instrument will serve as an early warning system for impending ulcers and Charcot fractures. The hypothesis is that the HealthScan device will provide an accurate and convenient approach to identify potential foot problems by monitoring dermal temperature changes on the plantar aspect of the foot. Aim 1. To fabricate and validate an infrared based version of the HeaithScan. First - Fabricate an infrared thermometry based HealthScan unit to measure the entire plantar aspect of the foot using a scanning technique. Second - To calibrate/validate the instrument using in vitro standards calibrated against NIST-traceable temperature probes using water baths held at various temperatures. Thereafter, we will verify accurate data transmission by the internal modem of the HealthScan. Aim 2. To examine in-clinic use of the HealthScan by diabetic patients. The HealthScan will be used in-clinic with 40 diabetic patients (20 with elevated temperatures and 20 with normal temperatures). Foot temperatures will be measured and then transmitted to a computer using the device's internal modem. Furthermore, the accuracy of the transmitted temperature data will be compared to a standard dermal thermometer.

描述（由申请人提供）：我们将为足部并发症高危糖尿病患者制造并验证一种家用设备（HealthScan）。这种红外步进式温度仪器将作为即将发生的溃疡和夏科骨折的早期预警系统。假设 HealthScan 设备将提供一种准确、方便的方法，通过监测足部足底的真皮温度变化来识别潜在的足部问题。 目标 1. 制造并验证基于红外的 HeaithScan 版本。首先 - 制造基于红外测温的 HealthScan 装置，使用扫描技术测量足部的整个足底部分。 第二 - 使用体外标准来校准/验证仪器，该标准使用不同温度下的水浴根据 NIST 可追踪温度探头进行校准。此后，我们将通过 HealthScan 的内部调制解调器验证数据传输的准确性。 目标 2. 检查糖尿病患者在诊所内使用 HealthScan 的情况。 HealthScan 将在诊所内对 40 名糖尿病患者（20 名体温升高，20 名正常体温）进行使用。 将测量脚部温度，然后使用设备的内部调制解调器将其传输到计算机。 此外，传输的温度数据的准确性将与标准皮肤温度计进行比较。