Continuous Glucose Sensors in Youth: Biobehavioral Study

青少年连续血糖传感器：生物行为研究

• 批准号: 6453501
• 负责人: Tim Wysocki
• 金额: $ 35.34万
• 依托单位: NEMOURS CHILDREN'S CLINIC
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6453501
• 关键词: adolescence (12-20); behavioral /social science research tag; blood glucose; blood tests; child behavior; clinical trials; cooperative study; data collection methodology /evaluation; diabetes mellitus therapy; disease /disorder prevention /control; hemoglobin As; hormone therapy; human subject; human therapy evaluation; hypoglycemia; insulin; insulin dependent diabetes mellitus; middle childhood (6-11); parent offspring interaction; patient monitoring device; patient oriented research; portable biomedical equipment; psychological tests; quality of life; statistics /biometry; time resolved data

DESCRIPTION (prepared by applicant): Intensive therapy for youths with type 1 diabetes mellitus (DM) yields higher HbA1c and more frequent severe hypoglycemia (SH) than for adults. The advent of continuous glucose sensors (CGS) could yield medical and psychological benefits for these youths. The investigators submit that many patients may not realize these benefits and that psychosocial features of patients and families will affect the outcomes of adding CGS to DM therapy. To maximize the therapeutic benefits of CGS, we need clinically useful information about its glycemic and psychological effects and about psychological influences on its therapeutic utility. This information would be useful in selecting candidates for this technology and for assisting patients and families in achieving positive outcomes from its use. This application addresses four specific aims: 1.) Evaluation of the effects of 12 month?s use of a CGS device (GlucoWatch Biographer, Cygnus, Inc.) on HbA1G, the Kovatchev Low Blood Glucose Index and the frequency of severe hypoglycemia; 2.) Identification of behavioral and psychological consequence of CGS use; 3.) Analysis of psychosocial predictors of metabolic and psychological outcomes; and 4.) Evaluation of glycemic profiles of healthy youths without DM, construction of a normative glycemic profile for use in future studies and comparison of the glycemic profiles of youths with and without diabetes. Specific Aims 1 through 3 will be addressed in a randomized, controlled trial of three intensive therapy regimens that are based on different glucose monitoring methods: SMBG patients will receive current intensive therapy with four to six self-monitored blood glucose tests daily; CGS with Feedback patients will augment SMBG by using a CGS device that gives immediate glucose feedback and alarms for high, low, and rapidly falling levels; CGS without Feedback patients will augment SMBG by using the same CGS device with the feedback and alarm functions disabled. Patients and parents will complete periodic assessments of demographic factors and general and diabetes-specific psychological factors. Statistical analyses will include multivariate analyses of variance, survival analysis and individual growth modeling techniques. Specific Aim 4 will be addressed by studying a demographically similar sample of 240 healthy children and adolescents who will use the GlucoWatch Biographer without feedback for a total of 144 hours during a two-week period. The project results will enhance clinical adoption of CGS technology.

描述（由申请人准备）：针对 1 型青少年的强化治疗 糖尿病 (DM) 产生更高的 HbA1c 且更常见的严重疾病 低血糖（SH）的发生率高于成人。连续血糖传感器的出现 （CGS）可以为这些年轻人带来医疗和心理上的好处。这 研究人员认为，许多患者可能没有意识到这些好处，并且 患者和家庭的心理社会特征会影响结果 将 CGS 添加到 DM 治疗中。为了最大限度地发挥 CGS 的治疗效果，我们 需要有关其血糖和心理的临床有用信息 效果以及对其治疗效用的心理影响。这 信息将有助于选择该技术的候选者，并且 协助患者和家庭取得积极成果 使用。该应用程序解决了四个具体目标： 1.) 评估 使用 CGS 设备 12 个月的影响（GlucoWatch Biographer、Cygnus、 Inc.）关于 HbA1G、Kovatchev 低血糖指数和频率 严重低血糖； 2.) 行为和心理的识别 使用 CGS 的后果； 3.) 代谢的社会心理预测因素分析 和心理结果； 4.) 健康人血糖曲线的评估 没有 DM 的青少年，构建标准血糖曲线以用于 未来的研究和青少年血糖状况的比较 没有糖尿病。具体目标 1 至 3 将在 三种强化治疗方案的随机对照试验 根据不同的血糖监测方法：SMBG 患者将接受 目前的强化治疗包括四到六次自我监测血糖测试 日常的;带反馈的 CGS 患者将通过使用 CGS 设备来增强 SMBG 提供即时血糖反馈以及高、低和快速下降的警报 级别；没有反馈的 CGS 患者将通过使用相同的 CGS 来增强 SMBG 禁用反馈和报警功能的设备。患者及家长 将完成对人口因素和一般和 糖尿病特有的心理因素。统计分析将包括 多变量方差分析、生存分析和个体成长 建模技术。具体目标 4 将通过研究来解决 240 名健康儿童和青少年在人口统计学上相似的样本 将使用 GlucoWatch Bioographer 总计 144 小时且无反馈 在两周的时间里。该项目结果将提高临床采用率 CGS 技术。