SEARCH for Diabetes in Youth Registry Study, Phase 4: Washington Center

青少年登记研究中的糖尿病搜索，第 4 阶段：华盛顿中心

• 批准号: 9753810
• 负责人: Catherine Pihoker
• 金额: $ 37.59万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-30 至 2020-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9753810
• 关键词: SEARCH; Diabetes; Youth; Registry; Study

 DESCRIPTION (provided by applicant): The SEARCH for Diabetes in Youth Study documented a 31% increase in the prevalence of type 2 diabetes (T2D) between 2001 and 2009, as well as an increase of 21 % in the prevalence of type 1 diabetes (T1D). Increases occurred across most but not all major subgroups of age, sex and race/ethnicity. Further, we documented an annual increase in the incidence of T1D among non-Hispanic White (NHW) youth of approximately 2.7% per year. In contrast, studies from Europe suggest that incidence of T1D may be stabilizing. Thus, compelling questions remain regarding long term trends in incidence and prevalence for both T1 and T2 in youth, particularly among various racial and ethnic population subgroups. Ongoing, efficient surveillance of diabetes diagnosed in youth is essential to inform health care systems and generate testable hypotheses related to the natural history of diabetes in youth. SEARCH is uniquely positioned to address these critical questions through continued surveillance of childhood diabetes employing our well-established infrastructure for surveillance, and its highly experienced, collaborative and multi-disciplinary investigative team. Therefore, in response to RFA-DP-15-002, Component A, we propose the continuation of the SEARCH for Diabetes in Youth Registry Study (SEARCH Phase 4) during which we will continue to ascertain newly diagnosed incident diabetes cases throughout the study period and one additional prevalent cohort (index year 2017) for youth age < 20 years across our five well-established geographically dispersed Study Centers. Our approach is informed by our substantial accrued experience that allows us to conduct surveillance work in a highly efficient manner. We frame our surveillance as an innovative three-tiered approach, starting with the most broad based and cost efficient approach at the highest tier (tier 1) and becoming the most focused in tier 3, with each tier optimizing use of electronic health records (EHRs). Specific Aims are: Aim 1: TIER 1 SURVEILLANCE (Prevalence)- To ascertain cases of prevalent diabetes in calendar year 2017 among youth age < 20 years at diagnosis; Aim 2: TIER 2 SURVEILLANCE (Incidence)- To continue to ascertain newly diagnosed (2015-2020) incident diabetes cases in youth age < 20 years; Aim 3: TIER 3 SURVEILLANCE (Clinical Characteristics) - To confirm classification of diabetes type using biochemical markers, to describe selected clinical characteristics at diagnosis, and to maintain an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants; Aim 4: OPERATIONAL EFFICIENCY: To optimize efficiency of the SEARCH Surveillance activities through targeted development and validation projects designed to utilize relevant electronic health data to operationalize each of the three tiers of surveillance. Thus, the well-established and highly productive SEARCH team is uniquely positioned to provide critical information on the prevalence, incidence and early clinical course of diabetes in youth.

 描述（由申请人提供）：青少年糖尿病研究记录显示，2001 年至 2009 年间，2 型糖尿病 (T2D) 患病率增加了 31%，1 型糖尿病 (T1D) 患病率增加了 21%。大多数但并非所有年龄、性别和种族/民族的主要亚组都出现了增加。此外，我们记录了非西班牙裔白人 (NHW) 青少年中 T1D 发病率每年增加约 2.7%。相比之下，来自欧洲的研究表明，T1D 的发病率可能趋于稳定。因此，关于青少年 T1 和 T2 发病率和患病率的长期趋势，特别是在不同种族和民族亚组中，仍然存在令人信服的问题。对青少年诊断出的糖尿病进行持续有效的监测对于为卫生保健系统提供信息并产生与青少年糖尿病自然史相关的可检验假设至关重要。 SEARCH 拥有独特的优势，可以通过利用我们完善的监测基础设施及其经验丰富的协作性多学科调查团队对儿童糖尿病进行持续监测来解决这些关键问题。因此，为了回应 RFA-DP-15-002 的 A 部分，我们建议继续开展青少年糖尿病登记研究（SEARCH 第 4 阶段），在此期间，我们将在整个研究期间继续确定新诊断的糖尿病病例，并在我们五个完善的地理分散研究中心中确定年龄 < 20 岁青少年的另一个流行队列（2017 年指数年）。我们的方法基于我们积累的丰富经验，使我们能够高效地开展监测工作。我们将监测设计为创新的三层方法，从最高层（第一层）最广泛、最具成本效益的方法开始，到第三层最集中，每一层都优化电子健康记录 (EHR) 的使用。具体目标是： 目标 1：一级监测（患病率）- 确定 2017 日历年诊断时年龄 < 20 岁的青少年中糖尿病的患病率病例；目标 2：二级监测（发病率）- 继续查明 20 岁以下青少年新诊断（2015-2020 年）糖尿病发病病例；目标 3：第 3 级监测（临床特征）——使用生化标志物确认糖尿病类型的分类，描述诊断时选定的临床特征，并维护基础设施，通过存储生物样本和保持与潜在研究参与者的联系，促进更详细的辅助研究的发展；目标 4：运营效率：通过有针对性的开发和验证项目来优化搜索监测活动的效率，该项目旨在利用相关电子健康数据来实施三级监测中的每一层。因此，完善且高效的 SEARCH 团队具有独特的优势，可以提供有关青少年糖尿病患病率、发病率和早期临床病程的关键信息。