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

一项试点临床试验，旨在评估患有 2 型糖尿病的亚裔美国人进行连续血糖监测的可行性、促进因素和障碍

• 批准号: 10709518
• 负责人: GEORGE L KING
• 金额: $ 21.31万
• 依托单位: JOSLIN DIABETES CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10709518
• 关键词: Address; Adherence; Advocacy; Affect; Age; Asian Americans; Body mass index; COVID-19 pandemic; COVID-19 severity; Cardiovascular Diseases; Caring; China; Chinese; Chinese American; Clinical Trials; Communities; Complications of Diabetes Mellitus; Continuous Glucose Monitor; Data; Diabetes Mellitus; Diagnosis; Disparity; Disparity in diagnosis; East Asian; Education; Environment; Ethnic Population; Exclusion; Face; Fingers; Future; Generations; Guidelines; Health; Health Technology; Healthcare; Immigrant; Impaired cognition; Intervention; Japanese; Kidney Diseases; Koreans; Language; Limited English Proficiency; Link; Lipids; Measures; Medicare/Medicaid; Metabolic; Methods; Minority; Modeling; National Health and Nutrition Examination Survey; Neuropathy; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Outcome; Participant; Patients; Population; Prevalence; Prevention; Protocols documentation; Provider; Quality of life; Randomized, Controlled Trials; Recommendation; Reporting; Resources; Retinal Diseases; SARS-CoV-2 infection; Site; South Asian; Subgroup; Technology; Uninsured; Variant; anti-Asian; arm; compliance behavior; cost; design; diabetes risk; digital; digital tool; ethnic disparity; ethnic minority; glucose monitor; glycemic control; health care disparity; implementation evaluation; implementation process; implementation strategy; innovation; literacy; monitoring device; open label; pandemic disease; policy implication; poor health outcome; programs; racial disparity; racial population; randomized, clinical trials; secondary outcome; sex; skills; social health determinants; social stigma; southeast Asian; systemic barrier; vocalization

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.

项目总结/摘要 2型糖尿病（T2 D）的发病率在全国和全球范围内都在增加。除了已知的T2 D 并发症，如视网膜病变、肾病、神经病变和心血管疾病，已知T2 D 影响认知障碍，甚至影响COVID-19感染的严重程度。一些研究表明， 持续葡萄糖监测（CGM）设备可更好地管理T2 D人群的血糖。而 T2 D的预防和管理协议无处不在，仍然存在大的种族/民族 美国普通民众之间的差距。亚裔美国人（AA），特别是华裔美国人，目前 由于以下原因，T2 D患病率和T2 D护理方面的差异要高得多：1） 从“模范少数民族神话”，加剧了反亚洲情绪在COVID-19期间上升 2）T2 D不知晓率较高; 3）文化和语言障碍，包括数字素养有限 和英语水平;和4）T2 D研究的历史排除，包括CGM器械和 T2 D，其中尚未在AA中评估CGM使用的文化相关促进因素和障碍。这 研究将专门研究如何通过CGM更好地管理华裔美国人的T2 D 与标准手指针刺血糖监测（FSGM）相比，我们将进行6- 一项为期一个月、单中心、开放标签的随机对照试验，检查CGM与无CGM（FSGM）的使用， 第一代华裔美国人我们的具体目标是：SP.目标1：在一项为期6个月的随机临床试验中， 在这项试验中，我们将研究第一代华裔美国T2 D患者使用CGM与不使用CGM的影响。 次级目标1.1.评估CGM使用期间的可行性（依从性和一致性）和生活质量指标， 这个人口。次级目标1.2.生成次要结局分布的精确估计值（6- 月血糖控制和脂质标志物），以告知未来的随机临床试验（RCT）。Sp. 目标2：使用一种方法，确定华裔美国T2 D患者使用CGM的多层次障碍和促进因素。 社会生态框架（患者层面、提供者层面和社区/环境层面）。我们将评估 实施过程（促进因素和障碍）、资源需求和中间患者 使用混合方法的方案的依从性结果。这将有助于文化设计- 为更大规模的随机对照试验量身定制干预措施。