Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D: 4T Study

新诊断儿童 T1D 的团队合作、目标、技术和严格控制：4T 研究

• 批准号: 10581678
• 负责人: David Matthew Maahs
• 金额: $ 67.79万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-07 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10581678
• 关键词: Automated Clinical Decision Support; Behavioral; Blood Vessels; Caring; Childhood; Childhood diabetes; Clinic; Clinical Trials; Communication; Complications of Diabetes Mellitus; Data; Detection; Diabetes Mellitus; Diagnosis; Dose; Education; Educational process of instructing; Failure; Family; Glucose; Glycosylated hemoglobin A; Goals; Habits; Health Policy; Healthcare; Insulin; Insulin-Dependent Diabetes Mellitus; International; Intervention; Literature; Medical Care Team; Methods; Monitor; Newly Diagnosed; Outcome; Patient Outcomes Assessments; Patients; Personal Satisfaction; Physiological; Population; Procedures; Provider; Psychosocial Assessment and Care; Publications; Recommendation; Reporting; Research; Resources; System; Technology; Testing; Translating; United States; Visit; blood glucose regulation; care delivery; clinical practice; data communication; data management; design; diabetes control; diabetes education; diabetes management; efficacy evaluation; flexibility; follow-up; improved; innovation; insulin dependent diabetes mellitus onset; multidisciplinary; patient response; pediatric health outcomes; personalized management; primary outcome; process improvement; programs; psychosocial; randomized trial; randomized, clinical trials; research study; response; screening program; support tools; telehealth; treatment program; trend

Project Summary: The goal of the 4T study is to implement proven methods and emerging diabetes technology into our clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient reported and psychosocial outcomes. We will define a program (4T---Teamwork, Targets, Technology and Tight Control) translatable to Pediatric Diabetes clinics in the United States that reduces HbA1c and T1D burden and improves patient well-being. In response to the R18 mechanism, we have designed a pragmatic approach to study a re-designed diabetes education and care delivery program in newly diagnosed Pediatric T1D patients. The primary outcome will be to implement 4T education and care in newly diagnosed T1D patients to reduce the rise in HbA1c observed 6 months post-diagnosis. We will compare results to historic data from our clinic and to contemporaneous new onset HbA1c data in the USA and internationally. Our secondary aims are to refine a systematic, pragmatic approach to monitoring longitudinal Patient Reported Outcomes and Psychosocial Outcomes and to develop and test in a randomized trial an automated system to detect the need for insulin dose adjustment in between quarterly visits. We will do so by using glucose data to generate personalized management recommendations based on each patient’s physiological and psychosocial data. The research outlined in this proposal aims to lower HbA1c, develop glucose data management and communication systems and support the psychosocial challenges of T1D in a program that is practical, sustainable, and translatable to other Pediatric Diabetes clinics in the US. Specific innovations will be to develop: 1) best practices for providers & T1D patients for glucose and psychosocial outcomes; 2) systems to identify patients with changing insulin needs based on glucose data obtained in between visits; 3) integration of these glucose data into EMR to incorporate into routine clinical practice. In sum, we propose leveraging existing staff and resources to test an innovative approach to improve T1D treatment in our clinic with the goal of obtaining results that will improve healthcare practice and inform healthcare policy for T1D management. We will assess factors that inform sustainability, acceptability, and feasibility. By design, the approach being tested is practical and sustainable with the potential to be broadly disseminated across the US and to improve processes of care and health outcomes for the Pediatric T1D population.

项目概要： 4T 研究的目标是将经过验证的方法和新兴的糖尿病技术应用到我们的临床中 从 1 型糖尿病 (T1D) 发病以来维持严格血糖控制并优化患者报告的实践 我们将定义一个计划（4T——团队合作、目标、技术和紧密） 对照）可转化为美国的小儿糖尿病诊所，可减少 HbA1c 和 T1D 负担， 改善患者的健康状况。 针对R18机制，我们设计了一种务实的方法来研究重新设计的糖尿病 新诊断的儿童 T1D 患者的教育和护理服务计划的主要结果是。 对新诊断的 T1D 患者实施 4T 教育和护理，以减少观察到的 HbA1c 上升 6 诊断后几个月，我们会将结果与我们诊所的历史数据以及同时期的新数据进行比较。 我们的次要目标是完善系统、务实的 HbA1c 数据。 监测纵向患者报告结果和社会心理结果并制定方法 并在随机试验中测试自动化系统，以检测之间是否需要调整胰岛素剂量 我们将通过使用血糖数据生成个性化的管理建议来做到这一点。 基于每个患者的生理和心理数据。 本提案中概述的研究旨在降低 HbA1c、开发血糖数据管理和 沟通系统，并通过实用的计划支持 T1D 的社会心理挑战， 可持续的，并且可以转化为美国其他儿童糖尿病诊所的具体创新。 制定：1) 为提供者和 T1D 患者提供血糖和心理社会结果的最佳实践；2) 系统； 根据就诊期间获得的血糖数据识别胰岛素需求变化的患者 3) 整合； 将这些血糖数据纳入 EMR 中，以纳入常规临床实践。 总之，我们建议利用现有员工和资源来测试改善 T1D 的创新方法 在我们诊所进行治疗，目的是获得改善医疗保健实践并提供信息的结果 我们将评估 T1D 管理的医疗政策的可持续性、可接受性和有效性。 从设计上看，正在测试的方法是实用且可持续的，具有广泛应用的潜力。 在美国传播并改善儿科 T1D 的护理流程和健康结果 人口。