Population-based Diabetes Youth Registry

基于人群的青少年糖尿病登记处

• 批准号: 9761922
• 负责人: Lynne E Wagenknecht
• 金额: $ 56.26万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 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/9761922
• 关键词: Population; based; Diabetes; Youth; Registry

 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) in youth diagnosed at age<20. 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 youth of approximately 2.7% per year. In contrast, studies from Europe suggest that incidence of T1D may be stabilizing. 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 our highly experienced, collaborative and multi-disciplinary investigative team. Therefore, in response to RFA-DP-15-002, Component B, we propose the continuation of the SEARCH for Diabetes in Youth Registry Study (SEARCH Phase 4) during which we will continue to serve as the Coordinating Center (CC). Our approach is informed by our substantial accrued experience that allows us to provide statistical and operational leadership in a highly efficient manner. The overarching aim of the CC is to support the population based registries of Component A described in the RFA, specifically the activities of the surveillance network and the validation of diabetes cases. The main objectives of the registries are to ascertain, among youth diagnosed at age < 20 years, cases of prevalent diabetes in calendar year 2017; ascertain newly diagnosed (2015-2020) incident diabetes cases; confirm classification of diabetes type using biochemical markers; and optimize efficiency of the surveillance activities through targeted projects designed to utilize relevant electronic health data. The main objectives of the CC to support the surveillance network are to: (1) Maintain a central data repository and create protocols and mechanisms to secure transmission of data and relevant data management reports between the CC and the registry sites; (2) Ensure the training and certification of staff on measurements and procedures as outlined in the protocol and manual of operations; (3) Provide expertise and leadership in population-based surveillance development, methodology, implementation, and evaluation; (4) Provide statistical and other analytic support to the registry network; (5) Provide for a central laboratory for the analysis of biological specimens; (6) Provide operational support to the registry network (communication and meetings). The main objectives of the CC to support the validation of diabetes cases are to: (1) Develop analytic methods for case validation; (2) Provide statistical/analytic support for validation analysis; (3) Maintain diabetes case validation protocols. Thus, the CC is uniquely positioned to provide leadership in statistical and operational issues that will support continued collection of data on the prevalence, incidence and early clinical course of diabetes in youth.

 描述(由申请人提供)：寻找青年糖尿病研究记录了2001至2009年间2型糖尿病(T2D)的患病率增加了31%，而在20岁确诊的青年中，1型糖尿病(T1D)的患病率增加了21%。大多数但不是所有主要的年龄、性别和种族/民族亚组的患病率都有增加。此外，我们记录了非西班牙裔白人青年中T1D发病率的年增长率约为2.7%。相比之下，来自欧洲的研究表明，T1D的发病率可能正在稳定下来。对青年中诊断的糖尿病进行持续、有效的监测对于向卫生保健系统提供信息并产生与青年糖尿病自然病史有关的可检验假说至关重要。Search通过利用我们完善的监测基础设施以及经验丰富、协作和多学科的调查团队对儿童糖尿病进行持续监测，从而处于独特的地位，能够解决这些关键问题。因此，针对RFA-DP-15-002，组件B，我们建议继续开展青年糖尿病研究(搜索阶段4)，在此期间，我们将继续担任协调中心(CC)。我们的做法得益于我们积累的丰富经验，使我们能够以高效的方式提供统计和业务领导。CC的总体目标是支持RFA中描述的A组分的基于人群的登记，特别是监测网络的活动和糖尿病病例的验证。登记处的主要目标是确定2017年日历年被诊断为20岁的青少年中的糖尿病流行病例；确定新诊断的(2015-2020年)糖尿病病例；利用生化标记物确认糖尿病类型的分类；并通过旨在利用相关电子健康数据的有针对性的项目来优化监测活动的效率。协调委员会支持监测网络的主要目标是：(1)维持一个中央数据储存库，并建立协议和机制，以确保数据和相关数据管理报告在协调委员会和登记册地点之间的传输；(2)确保就《议定书》和《操作手册》中概述的测量和程序对工作人员进行培训和认证；(3)在人口监测的发展、方法、实施和评价方面提供专门知识和领导；(4)向登记册网络提供统计和其他分析支助；(5)设立一个分析生物标本的中央实验室；(6)向登记处网络提供业务支助(通信和会议)。CC支持糖尿病病例验证的主要目标是：(1)开发用于病例验证的分析方法；(2)为验证分析提供统计/分析支持；(3)维护糖尿病病例验证协议。因此，协调委员会处于独特的地位，能够在统计和业务方面发挥领导作用。 这些问题将支持继续收集关于青年糖尿病的患病率、发病率和早期临床病程的数据。