Continuous Glucose Sensors in Youth: Biobehavioral Study

描述（由申请人编写）：1型糖尿病青少年强化治疗 糖尿病（DM）产生更高的HbA1c和更频繁的严重 低血糖症（SH）比成人。持续葡萄糖传感器的出现 (CGS)可以为这些年轻人带来医疗和心理上的好处。的 研究者认为，许多患者可能没有意识到这些益处， 患者和家属的心理社会特征会影响结果， 在糖尿病治疗中加入CGS为了最大限度地发挥CGS的治疗效益，我们 我需要临床上有用的信息， 影响和心理影响其治疗效用。这 这些信息将有助于选择这一技术的候选者， 帮助患者和家属从其治疗中取得积极成果 使用.本申请涉及四个具体目标：1.）评价 12个月的效果？使用CGS装置（GlucoWatch Biographer，Cygnus， Inc.）对HbA1G、Kovatchev低血糖指数和 严重低血糖; 2.）行为和心理的识别 使用CGS的后果; 3.）代谢性疾病的社会心理预测因素分析 心理影响;（4）健康人血糖谱的评价 无糖尿病的青年，建立用于 未来的研究和患有和患有糖尿病的青少年血糖谱的比较 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， 基于不同的血糖监测方法：SMBG患者将接受 目前的强化治疗，包括4至6次自我监测血糖测试 每天; CGS反馈患者将通过使用CGS器械来增加SMBG， 提供即时葡萄糖反馈，并对高、低和快速下降发出警报 水平;无反馈的CGS患者将通过使用相同的CGS来增加SMBG 禁用反馈和报警功能的设备。患者和家长 将完成对人口因素的定期评估， 糖尿病特有的心理因素。统计分析将包括 多变量方差分析、生存分析和个体生长 建模技术具体目标4将通过研究 240名健康儿童和青少年的人口统计学相似样本， 我将在没有反馈的情况下使用GlucoWatch Biographer总共144小时 在两周的时间里。该项目的结果将提高临床采用率 CGS技术。

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.