Implementation of a diabetes navIgator to Mitigate disPArities and improve CGM upTake and sustained use across the lifespan of T1D (IMPACT T1D)

项目摘要 1型糖尿病（T1 D）是一种慢性疾病，需要强化日常管理以维持 充分控制血糖，预防糖尿病相关并发症。只有不到20%的人符合 美国糖尿病协会的目标血红蛋白A1 c水平足够的血糖控制。糖尿病的使用 技术，特别是连续葡萄糖监测仪（CGMs），是护理标准， 血糖控制、健康相关生活质量和治疗满意度。尽管有这些好处， 特别是在少数群体和来自服务不足社区的个人中。增加吸收和 持续使用CGM可帮助改善血糖控制并减轻糖尿病相关结局的差异 服务不足的人。 在患者、提供者和系统层面，CGM的使用存在许多障碍，但没有 解决这些障碍的有效措施。在我们机构的一项试点研究中，我们证明， 在护理点进行标准化教育的试验CGM的放置增加了CGM的摄取，但是 克服知识障碍不足以确保个人和持续使用CGM。客观 该项目的目的是在我们的试点研究的基础上，在现实世界的临床环境中实施一种新的干预措施 这是可行的，可持续的和可推广的，以增加整个生命周期的CGM摄取-包括儿科， 新生儿和T1 D成人。 我们假设，实施糖尿病导航仪与试验CGM放置的支持， 将增加CGM摄取和持续使用，从而改善血糖 控制，将减轻差异糖尿病相关的结果与T1 D服务不足的个人。 在本提案中，我们将首先（目标1）根据利益相关者细化糖尿病导航员的角色和工具包 对解决CGM吸收和持续使用障碍的解决方案的反馈。借鉴 我们的试点研究，目标1的形成阶段，并利用我们的多学科的集体专业知识， 研究小组，我们将进行一项随机对照试验（目标2）的136人与T1 D，其中包括60 儿童和青少年以及76名成人，目前未使用CGM。受试者将被随机分配至（第1组） 标准治疗试验CGM放置（n=68），或（第2组）干预组试验CGM放置， 糖尿病导航员的支持（n=68）。我们假设糖尿病导航臂将具有更高的 CGM摄取和持续使用，（目标3）血糖控制和患者相关的 如果糖尿病导航器成功增加CGM， 被证明是一种可行、可接受和可持续的干预措施， 可以应用于更大的糖尿病社区，它有可能改善糖尿病护理和减轻 T1 D服务不足社区的糖尿病相关结局差异。

Project Summary Type 1 diabetes (T1D) is a chronic disease that requires intensive daily management to maintain adequate glycemic control and prevent diabetes-related complications. Less than 20% of individuals meet the American Diabetes Association goal hemoglobin A1c level for adequate glycemic control. Use of diabetes technologies, and specifically continuous glucose monitors (CGMs), are the standard of care, and improve glycemic control, health related quality of life and treatment satisfaction. Despite these benefits, CGMs are underutilized, particularly in minorities and individuals from underserved communities. Increasing uptake and continued use of CGM can help improve glycemic control and mitigate disparities in diabetes-related outcomes for underserved individuals. There are many barriers to CGM use at the patient, provider and systems levels, yet there are no proven interventions to address these barriers. In a pilot study at our institution, we demonstrated that placement of trial CGM with standardized education at the point of care increases CGM uptake, but overcoming the knowledge barrier is insufficient to ensure personal and sustained use of CGM. The objective of this project is to build upon our pilot study to implement a novel intervention in the real-world clinical setting that is feasible, sustainable and generalizable to increase CGM uptake across the lifespan - including pediatric, emerging adults, and adults with T1D. We hypothesize that implementing the support of a diabetes navigator with trial CGM placement at the point of care will increase CGM uptake and sustained use, leading to improvements in glycemic control that will mitigate disparities in diabetes related outcomes for underserved individuals with T1D. In this proposal, we will first (Aim 1) refine the role and toolkit of the diabetes navigator based on stakeholder feedback on solutions to address barriers to CGM uptake and sustained use. Building on the experience from our pilot study, the formative phase of Aim 1, and leveraging the collective expertise of our multidisciplinary study team, we will conduct a randomized controlled trial (Aim 2) of 136 individuals with T1D, including 60 children and adolescents and 76 adults, not currently using CGM. Participants will be randomized to (Arm 1) standard of care trial CGM placement (n=68), or (Arm 2) the intervention arm with trial CGM placement with the support from a diabetes navigator (n=68). We hypothesize that the diabetes navigator arm will have higher CGM uptake and sustained use, with (Aim 3) greater improvements in glycemic control and patient-related outcomes, compared to the standard of care arm. If the diabetes navigator is successful in increasing CGM uptake and sustained use, and is demonstrated to be a feasible, acceptable and sustainable intervention that can be applied to the larger diabetes community, it has the potential to improve diabetes care and mitigate disparities in diabetes related outcomes for underserved communities with T1D.