Implementation of foot thermometry and SMS to prevent diabetic foot ulcer

描述(由申请人提供)：本申请是对GACD的申请征集(非TW-14-003)，以响应现有的跨NIH传播和实施科学倡议(PAR-13-054)。据估计，全世界有2.85亿糖尿病患者，其中70%生活在低收入和中等收入国家。糖尿病的漏诊在LMIC中尤为重要，那里只有不到50%的糖尿病患者被诊断出来。如果在疾病的临床表现出现之前没有得到诊断，并发症和发病率就会呈指数上升。因此，在这些资源有限的情况下，糖尿病控制的主要挑战之一是需要一种资源适当的快速筛查方法来识别糖尿病患者并及早治疗，以延迟并发症的发生。糖尿病足神经病变(DFN)是足部截肢最重要的并发症之一，也是最重要的预后因素之一。早期诊断和干预可以预防足部溃疡和截肢，将糖尿病的社会和经济成本降至最低。诊断DFN的金标准是神经传导检查，但不幸的是，这非常昂贵和耗时。因此，这不是一种适合LMIC设置的技术，需要一种简单且廉价的监控方法。体温测量测量局部皮肤温度，是评估DFU的较有前途的新兴方法之一。然而，患者对居家监测的依从性是一个令人担忧的问题，因为他们可能健忘或发现很难进入一致的日常监测。因此，我们建议确定短信提醒患者进行体温测量的效用，并评估其对预后的影响。我们将把有溃疡风险的神经病变的糖尿病患者纳入一项有两个手臂的临床研究：两个手臂将在研究开始时接受关于DFU的教育，并将提供足温计和使用说明。他们将被要求每天记录多个脚温测量数据。然而，一只手臂也会收到短信，提醒他们使用温度计，而另一只手臂不会。通过本研究，我们将实现以下具体目标：具体目标1.比较两组研究期间DFU的发生率。我们假设，收到短信的受试者比没有收到短信的受试者发生DFU的几率更低。具体目标2.比较两个手臂的足部温度计的使用情况。我们假设，收到短信的受试者在体温测量方面会更加顺从。

DESCRIPTION (provided by applicant): This application is in response to the GACD solicitation of applications (NOT-TW-14-003) in response to the existing trans-NIH Initiative on Dissemination and Implementation Science (PAR-13-054). There are an estimated 285 million people worldwide living with diabetes, 70% of whom are in low and middle- income countries (LMIC). Underdiagnoses of diabetes is particularly significant in LMIC, where less than 50% of diabetics are diagnosed. When diagnosis does not occur before the onset of clinical manifestations of the disease, complications and morbidity rise exponentially. Therefore, one of the major challenges in diabetes control in these limited resource settings is the need for a resource-appropriate, rapid screening method to identify diabetics and treat them early enough to delay the onset of complications. Diabetic Foot Neuropathy (DFN) is one of the most important complications and is one of the most significant prognostics for foot amputation. Early diagnosis and intervention can prevent foot ulcers and amputation, minimizing the social and economic costs of diabetes. The gold standard for diagnosis of DFN is a nerve conduction study, but unfortunately this is very costly and time consuming. Therefore, this is not an appropriate technology for LMIC settings, and a simple and inexpensive monitoring method is needed. Thermometry measures local skin warmth and is one of the more promising emerging modalities for the evaluation of DFU. However, patient compliance with at-home monitoring is a concern, as they may be forgetful or find it difficult to get into a consistent routine of daily monitoring. Therefore, we propose to determine the utility of SMS messaging to remind the patients to perform the thermometry, and to assess the impact on outcome. We will enroll diabetic subjects with neuropathy at risk for ulceration into a clinical study with two arms: both arms will receive education about DFU at the beginning of the study, and will be provided with a foot thermometer and instructions on its use. They will be asked to record multiple foot temperature measurements on a daily basis. However, one arm will also receive text messages reminding them to use the thermometer, while the other arm will not. With this study, we will perform the following specific aims: Specific Aim 1. Compare the incidence of DFU during the study between the two arms. We hypothesize that subjects who receive SMS will have a lower incidence of DFU than the subjects who do not receive SMS. Specific Aim 2. Compare compliance with foot thermometer use between the two arms. We hypothesize that subjects who receive SMS will be more compliant with temperature measurement.