Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth

尽管有明确的证据表明患有T1D的非裔美国青年与糖尿病相关的健康差异， 几乎没有临床试验集中于测试行为干预以改善糖尿病的管理 这群人。缺乏研究来开发有效的干预措施来改善 鉴于冠状病毒2019年(新冠肺炎)的大流行，患有T1D的少数族裔青年更加担心。非洲 美国成年人和儿童收购新冠肺炎的风险可能不成比例，而且可能更高 可能遭受大流行的心理社会和经济负担。母体临床试验 该副刊已经成功招募了一大批具有代表性的城市、非洲人 患有T1D的美国青年(N=155)。新冠肺炎大流行在我们的临床试验中的发生 受试者间的差异，如果没有测量，可能会以未知的方式影响研究结果。因此，我们 建议直接测量三个与新冠肺炎相关的社会/行为应激源(心理压力)的影响 痛苦、医疗保健利用减少和财政资源损失)对我们两个主要试验结果的影响： 糖尿病管理和血糖控制。我们将通过三个新的渠道获得有关大流行影响的数据 在六个月期间收集了所有试验参与者的数据。副刊还将允许我们 评估新型冠状病毒大流行对患有T1D的少数族裔青年整体健康的影响。我们的 研究是进行这项关键工作的理想选择，这对于理解哪些社会/行为因素至关重要 与大流行相关的疾病正在影响这一高危人群的健康结果。反过来，这样的数据可以 告知未来缓解新冠肺炎影响的干预措施的发展情况。

Despite clear evidence of diabetes-related health disparities among African American youth with T1D, almost no clinical trials have focused on testing behavioral interventions to improve diabetes management for this population. The lack of research to develop effective interventions to improve health outcomes among minority youth with T1D is even more concerning in light of the coronavirus 2019 (COVID-19) pandemic. African American adults and children are likely to be at disproportionate risk to acquire COVID-19 and may be more likely to suffer from psychosocial and economic burdens of the pandemic. The parent clinical trial upon which the supplement will build has successfully recruited a large and representative sample of urban, African American youth with T1D (N=155). The occurrence of the COVID-19 pandemic in the midst of our clinical trial interjects variance that, if unmeasured, could affect study outcomes in ways that are unknown. Therefore, we propose to directly measure the effects of three COVID-19 related social/behavioral stressors (psychological distress, reduced health care utilization and loss of financial resources) on our two primary trial outcomes: diabetes management and glycemic control. We will obtain data on the impact of the pandemic via three new data collections obtained for all trial participants over a period of six months. The supplement will also allow us to evaluate the impact of the novel coronavirus pandemic on the overall health of minority youth with T1D. Our study is ideally posed to conduct this critical work, which is vital to understanding which social/behavioral factors associated with the pandemic are affecting health outcomes in this high-risk population. In turn, such data can inform the development of interventions to mitigate the effects of COVID-19 in the future.