Population-based diabetes in youth registry. SEARCH For Diabetes in Youth, Phase 4, California Site

 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（NHW）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。因此，关于青年T1和T2的发病率和患病率的长期趋势，特别是在各种种族和民族人群亚组中，仍然存在令人信服的问题。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和产生与青年糖尿病自然史相关的可验证假设至关重要。通过利用我们完善的监测基础设施及其经验丰富，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，为了响应RFA-DP-15-002，组分A，我们建议继续开展青年糖尿病登记研究（EST-IV期），在此期间，我们将继续确定整个研究期间新诊断的新发糖尿病病例，并在我们五个地理位置分散的成熟研究中心中确定一个年龄< 20岁的年轻人的额外流行队列（索引年2017年）。我们的做法是基于我们积累的大量经验，使我们能够以高效率的方式开展监测工作。我们将我们的监测框架定为一个创新的三层方法，从最高层（第1层）的基础最广泛和最具成本效益的方法开始，并成为第3层最集中的方法，每一层都优化了电子健康记录（EHR）的使用。具体目标是：目标1：第1层监控（患病率）-确定2017日历年诊断时年龄< 20岁的青年中糖尿病患病病例;目标2：二级监测（发病率）-继续确定新诊断的（2015-2020年）20岁以下青年糖尿病发病率;目标3：三级监管（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，并通过储存生物样本和保持与潜在研究参与者的联系，维持有利于开展更详细辅助研究的基础设施;目标4：运营效率：通过有针对性的开发和验证项目，利用相关的电子健康数据，使三级监测中的每一级都能运作，从而优化健康监测活动的效率。因此，完善和高生产力的糖尿病研究小组具有独特的地位，可以提供关于青年糖尿病患病率、发病率和早期临床病程的关键信息。

 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.