Population-based Diabetes Youth Registry

 描述（由申请人提供）：青年糖尿病研究中心记录了2001年至2009年期间2型糖尿病（T2 D）患病率增加31%，以及20岁以下青年诊断的1型糖尿病（T1 D）患病率增加21%。在大多数但非所有年龄、性别和人种/种族的主要亚组中均出现增加。此外，我们记录了非西班牙裔白色青年中T1 D发病率的年增长率约为2.7%。相反，欧洲的研究表明，T1 D的发病率可能趋于稳定。对青年糖尿病诊断进行持续有效的监测，对于告知卫生保健系统并产生与青年糖尿病自然史相关的可验证假设至关重要。通过使用我们完善的监测基础设施以及我们经验丰富，协作和多学科的调查团队，持续监测儿童糖尿病，我们处于独特的地位，可以解决这些关键问题。因此，作为对RFA-DP-15-002组分B的回应，我们建议继续开展青年糖尿病登记研究（EST 4期），在此期间，我们将继续担任协调中心（CC）。我们的方法是基于我们积累的大量经验，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中描述的组分A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。登记册的主要目标是确定2017日历年在20岁以下诊断的青年中流行的糖尿病病例;确定新诊断的（2015-2020年）糖尿病病例;使用生化标志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优化监测活动的效率。协调中心支持监测网络的主要目标是：（1）维持一个中央数据储存库，并制定协议和机制，以确保协调中心和登记中心之间的数据传输和相关数据管理报告;（2）确保对工作人员进行协议和操作手册中概述的测量和程序方面的培训和认证;（3）在基于人口的监测发展、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）提供一个中心实验室，用于分析生物标本;（6）为登记册网络提供业务支持（通信和会议）。CC支持糖尿病病例验证的主要目标是：（1）开发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方案。因此，协调委员会具有独特的地位，可以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患病率、发病率和早期临床病程的数据。

 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.