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(T1D)是一种慢性疾病，需要密集的日常管理来维持 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是使糖化血红蛋白水平达到适当的血糖控制。糖尿病的使用 技术，特别是连续血糖监测仪(CGM)，是护理和改进的标准 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，但CGMS 未得到充分利用，特别是在少数群体和服务不足社区的个人中。提高吸纳量和 继续使用CGM有助于改善血糖控制并缓解糖尿病相关结局的差异 针对服务不足的个人。 CGM的使用在患者、提供者和系统层面存在许多障碍，但没有 解决这些障碍的有效干预措施。在我们机构的一项试点研究中，我们证明了 试验性CGM在护理时接受标准化教育可增加CGM的摄取率，但 克服知识障碍不足以确保个人和持续使用CGM。目标是 这个项目的目的是在我们的先导研究的基础上，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CGM在整个生命周期--包括儿科--的摄入量， 新兴成人和患有T1D的成人。 我们假设，在糖尿病导航员的支持下进行CGM试验 在护理时将增加CGM的摄取和持续使用，导致血糖改善 这将缓解未得到充分治疗的T1D患者在糖尿病相关结局方面的差异。 在本提案中，我们将首先(目标1)基于利益相关者来细化糖尿病导航员的角色和工具包 关于解决CGM吸收和持续使用障碍的解决方案的反馈。基于以下方面的经验 我们的试点研究，目标1的形成阶段，并利用我们多学科的集体专业知识 研究小组，我们将对136名T1D患者进行随机对照试验(AIM 2)，其中包括60名 儿童和青少年以及76名成年人，目前未使用CGM。参与者将被随机分配到(ARM 1) 标准护理试验CGM放置(n=68)，或(手臂2)介入臂试验CGM放置 糖尿病导航员的支持(n=68)。我们假设糖尿病导航员的手臂会有更高的 CGM摄取和持续使用，(目标3)在血糖控制和患者相关方面有更大改善 结果，与护理臂的标准相比。如果糖尿病导航员成功增加CGM 摄取和持续使用，并被证明是可行的、可接受的和可持续的干预措施 可以应用于更大的糖尿病社区，它具有改善糖尿病护理和缓解 患有T1D的未得到充分服务的社区中糖尿病相关结局的差异。

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.