A pilot clinical trial to assess feasibility, facilitators and barriers of continuous glucose monitoring in Asian Americans with type 2 diabetes

项目摘要/摘要 2型糖尿病(T2D)的发病率在全国和全球范围内都在上升。除了已知T2D之外 并发症，如视网膜病变、肾病、神经病变和心血管疾病，T2D已知 影响认知障碍甚至新冠肺炎感染的严重程度。一些研究已经表明， 连续血糖监测(CGM)设备，用于更好地管理T2D人群的血糖。而当 T2D的预防和管理方案无处不在，仍然存在大量的种族/民族 美国普通民众之间的差距。亚裔美国人，特别是华裔美国人出席 由于以下原因，T2D患病率和T2D护理中的面孔差异要高得多：1)产生耻辱 从“模范少数族裔神话”，到新冠肺炎期间反亚情绪的高涨而加剧 大流行；2)更高的T2D不知晓率；3)文化和语言障碍，包括有限的数字素养 和英语水平；以及4)历史上被排除在T2D研究之外，包括那些关于CGM设备和 T2D，其中与文化相关的促进者和使用CGM的障碍尚未在AAS中进行评估。这 这项研究将专门研究如何通过CGM更好地管理T2D 干预，与标准的指棒血糖监测(FSGM)相比。我们将进行一次6- 一个月、单部位、开放标签的随机对照试验，检查CGM和未使用CGM(FSGM)在 第一代华裔美国人。我们的具体目标是：SP。目标1：在为期6个月的试验性随机临床试验中 试验中，我们将考察使用CGM和不使用CGM在第一代华裔美国人中使用T2D的影响。 次级目标1.1。评估CGM使用期间的可行性(遵守和一致性)和生活质量测量 这群人。分目标1.2。对次要结果的分布进行精确估计(6- 一个月的血糖控制和血脂标志物)，以通知未来的随机临床试验(RCT)。SP. 目标2：确定华裔美国人使用CGM的多级障碍和促进者，使用T2D 社会生态框架(患者级、提供者级和社区/环境级)。我们将评估 实施过程(促进者和障碍)、资源要求和中间患者 使用混合方法的方案的坚持结果。这些将在文化上为设计提供信息- 为更大规模的随机对照试验量身定做的干预。

Project Summary/Abstract Rates of Type 2 Diabetes (T2D) are increasing both nationally and globally. In addition to known T2D complications such as retinopathy, nephropathy, neuropathy, and cardiovascular disease, T2D is known to affect cognitive impairment and even severity of COVID-19 infection. A few studies have shown the benefit of Continuous Glucose Monitoring (CGM) devices for better glycemic management in T2D populations. While prevention and management protocols for T2D are ubiquitous, there continue to exist large racial/ethnic disparities amongst the general US population. Asian Americans (AA), specifically Chinese-Americans, present with much higher T2D prevalence and face disparities in T2D care for the following reasons: 1) Stigma arising from the “model minority myth”, exacerbated by the rise in anti-Asian sentiments during the COVID-19 pandemic; 2) Higher T2D unawareness rate; 3) Cultural and language barriers including limited digital literacy and English proficiency; and 4) Historical exclusion from T2D studies, including those on CGM devices and T2D, in which culturally-relevant facilitators and barriers to CGM use have yet to be evaluated in AAs. This study will specifically examine how T2D could be better managed in Chinese Americans through a CGM intervention, as compared to standard fingerstick glucose monitoring (FSGM). We will be conducting a 6- month, single-site, open-labeled randomized controlled trial examining CGM versus no CGM (FSGM) use in 1st-generation Chinese Americans. Our specific aims are: Sp. Aim 1: In a pilot 6-month randomized clinical trial, we will examine the impact of CGM use vs. No CGM among 1st generation Chinese Americans with T2D. Sub-Aim 1.1. Evaluate feasibility (adherence and consistency) and quality of life measures during CGM use in this population. Sub-Aim 1.2. Generate precision estimates of the distribution of the secondary outcomes (6- month glycemic control and lipid markers) in both arms to inform a future randomized clinical trial (RCT). Sp. Aim 2: Identify multi-level barriers and facilitators of CGM use for Chinese Americans with T2D, using a socioecological framework (patient-level, provider-level, and community/environment level). We will evaluate the implementation process (facilitators and impediments), resource requirements, and intermediate patient adherence outcomes for the program using mixed-methods approaches. These will inform design of culturally- tailored intervention for a larger randomized controlled trial.