FQHC Intervention for CGM Uptake in Hispanic Adults with T1D

摘要 患有1型糖尿病(T1D)的低收入西班牙裔成年人经历了不成比例的危及生命的负担， 急性并发症，包括低血糖和糖尿病酮症酸中毒，相关急诊率高 科室就诊、住院和死亡。使用连续血糖监测(CGM)可能会缓解这些 不平等。然而，患有T1D的拉美裔人使用CGM的水平非常低。这反映了社会决定因素。 社会--生态模式的多层次框架内的健康问题。经济局局长的医疗保健 提供者层面是西班牙裔被剥夺CGM权利的主要驱动因素。与严重短缺的 内分泌学家、初级保健提供者越来越多地管理T1D，尽管绝大多数人报告说 对胰岛素滴定和使用CGM信心不足。获得内分泌学的机会有限，低收入， 因此，患有T1D的西班牙裔成年人经常在联邦合格的健康中心(FQHC)接受糖尿病治疗 很少或根本不能接触到CGM。因此，为了促进CGM在最脆弱的西班牙裔美国人中的公平接受 成人T1D是一项为期4年的混合方法可行性研究，采用先导性随机对照试验(RCT) 建议初步评估扫描电子显微镜引导干预(针对个人、家庭/社会)的可行性 网络和医疗保健提供者级别)。干预的个体水平促进了基本的获得 通过两种途径获取CGM的信息、动机和行为技能：(1)为期4周，个性化， 与获得糖尿病教育认证的RN进行CGM会议；以及(2)在数据之间进行同伴教育访问 收集点。家庭/社会网络层面利用了家庭主义和西班牙裔的核心价值观 集体主义与家庭成员共同参加为期4周的会议，以促进对CGM接纳的关键支持 以及参与者在预定的访问期间与同伴教育者的互动。的提供程序级别 干预旨在促进干预交付中增强的文化能力，并提供临床 通过严格的T1D管理培训为CGM提供支持，并通过Echo项目为CGM提供支持。在研究阶段 1(目标1)，将根据利益攸关方的定性调查结果进行干预，并将进行随机对照试验部署 计划4个FQHC站点，随机提供干预(n=2)或对照(n=2)条件，总共 招生目标为30名具有T1D学位的拉美裔美国人(注册率大致相同的网站)。Echo项目：CGM &T1D关怀也将提供给干预现场提供者。在第二阶段(目标2)，研究的可行性 议定书(例如，招聘和留用收益率、数据收集程序、干预实施和 除其他外，将定期评估干预措施的可接受性。在阶段2(目标3)，重大干预 生理方面的信号(例如，A1C和时间在范围内、上方和下方)、心理方面(例如，质量 生活、家庭支持、医生信任)和行为(CGM依从性)结果从基线到3-和6- 将在基线后几个月进行评估。本研究的长期目标是为大型、多站点的RCT提供信息，并 成功的结果为全国FQHC中患有T1D的西班牙裔成年人提供了CGM摄取的模型

Abstract Low-income Hispanic adults with type 1 diabetes (T1D) experience a disproportionate burden of life-threatening, acute complications, both hypoglycemia and diabetes ketoacidosis, with high rates of related emergency department visits, hospitalizations, and death. Use of continuous glucose monitoring (CGM) may mitigate these inequities. Yet, Hispanics with T1D have exceptionally low levels of CGM use. This reflects social determinants of health (SODH), as framed by the multiple levels of the Socio-Ecological Model (SEM). The SEM’s healthcare provider level is a main driver in Hispanic disenfranchisement from CGM. With a severe shortage of endocrinologists, primary care providers are increasingly managing T1D although a high majority report inadequate confidence in titrating insulin and using CGM. With limited access to endocrinology, low-income, Hispanic adults with T1D thus often receive diabetes management in federally qualified health centers (FQHCs) with scant or no access to CGM. Hence, to foster equitable uptake of CGM in the most vulnerable Hispanic adults with T1D, a 4-year, mixed-methods, feasibility study with a pilot randomized controlled trial (RCT) is proposed to primarily assess the feasibility of the SEM-guided intervention (targeting the individual, family/social networks, and healthcare provider levels). The individual level of the intervention fosters essential acquisition of information, motivation, and behavioral skills for CGM uptake through two approaches: (1) 4-week, personalized, CGM sessions with a RN certified in diabetes education; and (2) followed by peer education visits between data collection points. The family/social networks level leverages the core Hispanic values of familismo and collectivismo to promote critical support in CGM uptake with a family member co-attending the 4-week sessions and participant engagement with a peer educator during scheduled visits, respectively. The provider level of the intervention is designed to promote enhanced cultural competency in intervention delivery and provide clinical support for CGM informed by rigorous training in T1D management and CGM via Project ECHO. In study phase 1 (Aim 1), the intervention, informed by stakeholder qualitative findings, will be refined and RCT deployment will be planned with 4 FQHC sites randomized to deliver the intervention (n=2) or control (n=2) conditions with a total enrollment goal of 30 Hispanics with T1D (sites having roughly equivalent enrollment rates). Project ECHO: CGM & T1D Care will also be delivered to intervention site providers. In phase 2 (Aim 2), the feasibility of the study protocol (e.g., recruitment and retention yields, data collection procedures, intervention implementation, and intervention acceptability, among others) will be routinely assessed. In phase 2 (Aim 3), significant intervention signals in terms of physiological (e.g., A1C and time within, above, and below range), psychosocial (e.g., quality of life, family support, physician trust), and behavioral (CGM adherence) outcomes from baseline to 3- and 6- months postbaseline will be assessed. The long-term goal of this study is to inform a large, multi-site RCT, and with successful results, provide a model for CGM uptake in Hispanic adults with T1D for FQHCs nationally