Accuracy of Blood Glucose Detection by Diabetes Alert Dogs (DADs)

描述(申请人提供)：尽管越来越多的人对训练有素的糖尿病警报犬(DADS)作为1型糖尿病(T1D)血糖(BG)监测的替代方法感兴趣和使用，但还没有科学研究证实DADS能够准确检测低血糖和高血糖。拟议的项目将对糖尿病警报犬(DADS)的准确性进行第一次初步调查，使用类似于证明BG测量仪准确性所需的科学严格的研究方法。具体地说，该项目的主要目的是测试假设，即父亲在检测患有T1D的成人和儿童的低血糖和高血糖(BG)水平时是准确的。拟议的项目还有其他几个次要目标，其中包括确定：1)低血糖和高血糖DAD警报的血糖阈值和时间进程，2)不同父亲警报的准确性一致的程度，以及3)与糖尿病人群的标准数据相比，DAD所有者是否经历了更好的心理社会状况和生活质量。为了实现这些主要和次要的目标，DAD警报将与从连续血糖监测(CGM)设备和血糖测量仪(BGM)获得的带有时间戳的血糖读数进行比较。共有10名患有T1D的成年人以及10名患有T1D的儿童及其父母将参与为期4周的数据收集方案。在这个为期4周的方案中，T1D参与者将佩戴一个不在接收器上显示血糖读数的“盲式”CGM设备。他们还将遵循BGM日常使用的常规说明，其中包括每当发生父亲警报时获取BGM读数。此外，参与者将使用CGM设备上的事件记录器来记录DAD警报的发生。为了收集更详细的爸爸警报信息，患有T1D的成年人和患有T1D儿童的父母还将使用之前开发的计算机框架在研究网站上完成电子每日爸爸日记，以记录有关爸爸警报的信息。该信息将包括警报时间、警报类型(低/高)、警报期间的DAD行为、警报的位置 警报是在白天还是夜间在睡眠中发生，以及为警报获取的BGM读数。在为期4周的计划结束时，将匹配和比较带有时间戳的CGM、BGM和Daily Dad日记数据。数据分析将利用信号检测理论方法，在误差网格分析标准的指导下，确定DAD警报中的命中率、未命中率和误警率。在开始为期4周的计划之前，参与者还将完成一系列评估糖尿病相关心理社会状况和生活质量的问卷。这些问卷得分将与现有的标准数据进行比较，作为初步测试，以确定爸爸的主人是否表现出较少的糖尿病相关情绪困扰和更高的生活质量。拟议项目的结果将为未来研究和临床使用DADS作为血糖监测技术方法的可行和可靠的替代方法奠定重要基础。

DESCRIPTION (provided by applicant): Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as an alternative method of blood glucose (BG) monitoring in type 1 diabetes (T1D), no scientific studies have confirmed the ability of DADs to accurately detect hypo- and hyperglycemia. The proposed project would conduct the first preliminary investigation into the accuracy of Diabetes Alert Dogs (DADs), using scientifically rigorous research methods similar to those required to demonstrate accuracy in BG meters. Specifically, the primary aim of the project is to test the hypotheses that DADs are accurate at detecting hypo- and hyperglycemic blood glucose (BG) levels in adults and children with T1D. The proposed project has several other secondary aims, which include determining: 1) the glycemic thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to which alert accuracy is consistent across different DADs, and 3) whether or not DAD owners appear to experience better psychosocial status and quality of life compared to normative data for the diabetes population. To achieve these primary and secondary aims, DAD alerts will be compared to time-stamped glucose readings obtained from a continuous glucose monitoring (CGM) device and a BG meter (BGM). A total of 10 adults with T1D, as well as 10 children with T1D and their parents, will participate in a 4 - week data collection protocol. During this 4-week protocol, T1D participants will wear a "blinded" CGM device that does not display glucose readings on the receiver. They will also follow routine instructions for daily use of BGM, which includes obtaining a BGM reading whenever a DAD alert occurs. In addition, participants will utilize the event recorder on the CGM device to record the occurrence of DAD alerts. To collect more detailed information about DAD alerts, adults with T1D and parents of children with T1D will also use a previously developed computer framework to complete electronic Daily DAD Diaries on a study website to record information about DAD alerts. This information would include time of alert, type of alert (low/high), DAD behaviors during alert, location of the alert, whether the alert occurred during the day or nocturnally during sleep, and BGM readings obtained for the alert. At the end of the 4-week protocol, the time-stamped CGM, BGM, and Daily DAD Diary data will be matched and compared. Data analysis will utilize a Signal Detection Theory Approach, guided by Error Grid Analysis criteria, to determine the rate of Hits, Misses, and False Alarms in DAD alerts. Prior to beginning the 4-week protocol, participants will also complete a battery of questionnaires assessing diabetes-related psychosocial status and quality of life. These questionnaire scores will be compared to available normative data as a preliminary test of whether or not DAD owners show less diabetes-related emotional distress and enhanced quality of life. The findings of the proposed project will lay an important foundation for future research into and clinical use of DADs as a viable and reliable alternative to technological methods of BG monitoring.