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.

项目总结/文摘