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

糖尿病警戒犬 (DAD) 血糖检测的准确性

基本信息

批准号：
8705512
负责人：
Linda Ann Gonder-Frederick
金额：
$ 19.75万
依托单位：
UNIVERSITY OF VIRGINIA
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-01 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8705512
关键词：
Adult Attention Behavior Belief Blinded Blood Glucose Breeding Canis familiaris Child Clinical Data Data Analyses Data Collection Detection Devices Diabetes Mellitus Effectiveness Electronics Event Exhibits Family Federal Government Foundations Frequencies Fright Glucose Goals Hyperglycemia Hypoglycemia Individual Instruction Insulin-Dependent Diabetes Mellitus Investigation Life Location Measures Methods Parents Participant Persons Pilot Projects Population Procedures Protocols documentation Quality of life Questionnaires Reading Research Methodology Resources Services Signal Detection Analysis Signal Transduction Sleep System Testing Time Training Universities Virginia base blood glucose regulation computer framework cost diabetes management diaries emotional distress experience glucose monitor improved interest meter monitoring device psychosocial public health relevance web site

项目摘要

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.

描述（由申请人提供）：尽管人们对训练有素的糖尿病警戒犬 (DAD) 作为 1 型糖尿病 (T1D) 血糖 (BG) 监测的替代方法越来越感兴趣，但没有科学研究证实 DAD 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（DAD）的准确性进行首次初步调查，使用类似于证明血糖计准确性所需的科学严谨的研究方法。具体来说，该项目的主要目的是测试 DAD 能否准确检测成人和儿童 T1D 低血糖和高血糖 (BG) 水平的假设。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 DAD 之间警报准确性的一致程度，以及 3）与糖尿病人群的规范数据相比，DAD 所有者是否似乎经历了更好的心理社会状态和生活质量。为了实现这些主要和次要目标，DAD 警报将与从连续血糖监测 (CGM) 设备和血糖仪 (BGM) 获得的带时间戳的血糖读数进行比较。总共 10 名患有 T1D 的成人以及 10 名患有 T1D 的儿童及其父母将参加为期 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“盲”CGM 设备，该设备不会在接收器上显示葡萄糖读数。他们还将遵循日常使用 BGM 的常规说明，其中包括在发生 DAD 警报时获取 BGM 读数。此外，参与者将利用 CGM 设备上的事件记录器来记录 DAD 警报的发生。为了收集有关 DAD 警报的更多详细信息，T1D 成人和 T1D 儿童家长还将使用先前开发的计算机框架在研究网站上完成电子每日 DAD 日记，以记录有关 DAD 警报的信息。此信息将包括警报时间、警报类型（低/高）、警报期间的 DAD 行为、警报位置、警报是发生在白天还是夜间睡眠期间，以及为警报获取的 BGM 读数。在 4 周的方案结束时，将匹配和比较带时间戳的 CGM、BGM 和每日 DAD 日记数据。数据分析将利用信号检测理论方法，以错误网格分析标准为指导，确定 DAD 警报中的命中率、未命中率和误报率。在开始为期 4 周的方案之前，参与者还将完成一系列调查问卷，评估与糖尿病相关的心理社会状态和生活质量。这些问卷得分将与现有的规范数据进行比较，作为初步测试 DAD 所有者是否表现出较少的与糖尿病相关的情绪困扰和提高的生活质量。该项目的研究结果将为 DAD 的未来研究和临床应用奠定重要基础，作为 BG 监测技术方法的可行且可靠的替代方案。