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.

项目摘要/摘要 2型糖尿病（T2D）的发生率在全国和全球范围内都在增加。除了已知的T2D 诸如视网膜病，肾病，神经病和心血管疾病等并发症已知 一些研究表明，影响认知障碍甚至Covid-19感染的严重程度的好处。 连续葡萄糖监测（CGM）设备，可在T2D种群中获得更好的血糖管理。尽管 T2D的预防和管理协议无处不在，继续存在大型种族/种族 美国普通人口之间的差异。亚裔美国人（AA），特别是中国美国人 由于以下原因，T2D的患病率更高，并且在T2D护理中面临差异：1）污名 从“型少数族裔神话”中，反亚洲情绪的兴起在COVID-19中加剧了 大流行; 2）较高的T2D不认识率； 3）文化和语言障碍，包括有限的数​​字素养 和英语水平； 4）T2D研究中的历史排除，包括在CGM设备上的研究和 T2D，与文化相关的促进者和CGM使用的障碍尚未在AAS中进行评估。这 研究将专门研究如何通过CGM更好地在华裔美国人管理T2D 与标准的指法葡萄糖监测（FSGM）相比，干预措施。我们将进行6- 一个月，单位，开放标记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。我们的具体目的是：sp。目标1：在一个飞行员6个月的随机临床中 试验，我们将研究CGM使用与无CGM在具有T2D的第一代美国人中的影响。 Sub-aim 1.1。评估CGM使用期间的可行性（依从性和一致性）和生活质量度量 这个人口。 Sub-aim 1.2。生成次级结果分布的精确估计（6- 两个臂中的月血糖控制和脂质标记），以告知未来的随机临床试验（RCT）。 sp。 AIM 2：使用A的多层障碍和CGM使用的多层障碍和促进者使用T2D的中国美国人 社会生态框架（患者级，提供者级别和社区/环境水平）。我们将评估 实施过程（促进者和障碍），资源需求和中级患者 使用混合方法方法来遵守该程序的结果。这些将为文化设计提供信息 - 针对大型随机对照试验的量身定制干预措施。