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: 10511276
• 负责人: GEORGE L KING
• 金额: $ 25.56万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10511276
• 关键词: Address; Adherence; Advocacy; Affect; Age; Asian; 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; Data; Diabetes Mellitus; Diagnosis; East Asian; Education; Environment; Ethnic group; Exclusion; Face; Future; Generations; Guidelines; Health; Health Technology; Healthcare; Immigrant; Impaired cognition; Intervention; Japanese; Kidney Diseases; Koreans; Language; Limited English Proficiency; Link; Lipids; Measures; Medicaid; Medicare; 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; Race; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Resources; Retinal Diseases; SARS-CoV-2 infection; Site; South Asian; Subgroup; Technology; Uninsured; Variant; arm; compliance behavior; cost; design; diabetes risk; digital; 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; programs; racial and ethnic disparities; secondary outcome; sex; skills; social health determinants; social stigma; southeast Asian; tool; 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.

项目概要/摘要 除了已知的 T2D 之外，2 型糖尿病 (T2D) 的发病率在全国和全球范围内都在增加。 众所周知，T2D 会导致视网膜病变、肾病、神经病变和心血管疾病等并发症 影响认知障碍，甚至影响 COVID-19 感染的严重程度，一些研究表明了其益处。 连续血糖监测 (CGM) 设备可更好地管理 T2D 人群的血糖。 T2D 的预防和管理方案无处不在，仍然存在大量的种族/族裔 美国亚裔美国人（AA），特别是华裔美国人之间存在着不平等。 T2D 患病率要高得多，并且由于以下原因而面临 T2D 护理方面的差异： 1) 耻辱感的产生 源自“模范少数族裔神话”，并因 COVID-19 期间反亚裔情绪的高涨而加剧 流行病；2) 较高的 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) 曾被排除在 T2D 研究之外，包括 CGM 设备和 T2D，其中 CGM 使用的文化相关促进因素和障碍尚未在 AA 中进行评估。 研究将专门研究如何通过 CGM 更好地管理华裔美国人的 T2D 与标准指尖血糖监测 (FSGM) 相比，我们将进行 6-干预。 一个月的单中心、开放标记随机对照试验，检查 CGM 与不使用 CGM (FSGM) 的情况 第一代美籍华人的具体目标是： 目标 1：进行为期 6 个月的随机临床试验。 在该试验中，我们将研究使用 CGM 与不使用 CGM 对患有 T2D 的第一代美籍华人的影响。 子目标 1.1 评估 CGM 使用期间的可行性（依从性和一致性）和生活质量措施 子目标 1.2. 生成次要结果分布的精确估计 (6- 月血糖控制和血脂标志物）为未来的随机临床试验（RCT Sp）提供信息。 目标 2：确定患有 T2D 的美籍华人使用 CGM 的多层次障碍和促进因素 我们将评估社会生态框架（患者层面、提供者层面和社区/环境层面）。 实施过程（促进因素和障碍）、资源需求和中间患者 使用混合方法的计划的遵守结果将为文化设计提供信息。 为更大规模的随机对照试验量身定制干预措施。