Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults with T1D

项目摘要/摘要 患有1型糖尿病(T1D)的青少年和青壮年(Aya)尤其有可能错过糖尿病就诊 以及不理想的自我护理行为，这从他们血糖控制不佳和非常高的A1c水平就可见一斑。 此外，糖尿病困扰在患有T1D的Aya患者中很常见，并导致他们的自我护理行为不佳 和结果。美国糖尿病协会(ADA)建议对糖尿病痛苦进行常规筛查 以及，一旦确定，将转诊为糖尿病教育或心理健康治疗。患有糖尿病的人 因错过就诊时间和糖尿病自我管理能力不足而陷入困境的风险增加。这是 令人担忧的是，如果没有干预，糖尿病痛苦不会缓解，要么保持稳定，要么 随着时间的推移会愈演愈烈。此外，由于以下原因，AYA可能无法充分获得或使用先进的糖尿病技术 自我护理负担可能增加和糖尿病痛苦的看法，而事实上，这种技术 可以帮助他们加强自我护理和改善血糖控制的努力。因此，迫切需要 开发针对糖尿病痛苦、自我护理和血糖升高的实用且可广泛获得的干预措施 控制并包括面对面和远程访问，以促进了解。在建议的2年期随机调查中 临床试验，我们将实施和评估行为/心理教育干预的影响，以减少 糖尿病痛苦，提高自我护理行为的接受度(使用或不使用糖尿病技术)，以及 改善服用T1D的AYAS患者的血糖结果。作为一个群体，带有T1D的AYA代表所有AYA的亚群 T1D患者的一生中血糖控制最差，达到峰值平均A1c 在19岁时下降9%。患有T1D的Ayas经常经历糖尿病困扰，这与血糖控制不良有关， 使他们成为拟议研究的理想参与者。我们将招募180名具有T1D的AYA(年龄在14-25岁) 病程至少1年，糖尿病控制不佳(A1C8-13%)。参与者将被随机分配 至常规护理控制条件或干预组。干预组每月参加一次 在第一年与研究干预者进行干预。在每月的会议中，4个将重点放在 在面对面的会议中改善血糖结果，8将专注于减少偏远地区的糖尿病痛苦， 虚拟会议以限制学习负担(并认识到SARS期间护理提供的范式变化- CoV-2大流行)。为了确保足够的招聘和留住，控制组将收到延迟的 在研究的第二年进行干预，并参加每月的会议。两个小组都将使用 连续血糖监测(CGM)每3个月14天，每6个月完成一次。A1C 还将每6个月集中测量一次。我们将对两组的初级血糖进行比较 CGM评估70-180 mg/dL范围内时间百分比(TIR)的结果以及 从基线到1年的糖尿病痛苦和糖化血红蛋白。我们假设干预组将有一个 与常规护理对照组相比，TIR百分比、糖尿病痛苦和糖化血红蛋白均有改善。

PROJECT SUMMARY/ABSTRACT Adolescents and young adults (AYA) with type 1 diabetes (T1D) are especially at risk for missed diabetes visits and suboptimal self-care behaviors, as evidenced by their poor glycemic control with very high A1c levels. Further, diabetes distress is common in AYA with T1D and contributes to their suboptimal self-care behaviors and outcomes. The American Diabetes Association (ADA) recommends routine screening for diabetes distress and, when identified, referral for diabetes education or mental health treatment. Persons experiencing diabetes distress are at increased risk for missed medical appointments and deficient diabetes self-management. This is concerning because, without intervention, diabetes distress does not remit and either remains stable or intensifies over time. Further, AYAs may not adequately access or use advanced diabetes technologies due to perceptions of possible increases in self-care burden and diabetes distress when, in fact, such technologies could aid in their efforts to enhance self-care and improve glycemic control. Thus, there is an urgent need to develop practical and widely accessible interventions that target diabetes distress, self-care, and glycemic control and include face-to-face and remote visits to facilitate uptake. In the proposed 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress, increase acceptance of self-care behaviors (with or without diabetes technologies), and improve glycemic outcomes in AYAs with T1D. As a group, AYAs with T1D represent the subpopulation of all persons with T1D across the lifespan that has the poorest glycemic control, reaching a peak mean A1c value >9% at age ~19. AYAs with T1D often experience diabetes distress, which is linked to poor glycemic control, making them ideal participants for the proposed study. We will recruit 180 AYAs (ages 14-25) with T1D duration of at least 1 year and suboptimal diabetes control (A1c 8-13%). Participants will be randomly assigned to a usual care control condition or the intervention group. The intervention group will participate in monthly intervention sessions with a study interventionist during the first year. Of the monthly sessions, 4 will focus on improving glycemic outcomes in face-to-face sessions and 8 will focus on reducing diabetes distress in remote, virtual sessions to limit study burden (and in recognition of paradigm changes in care delivery during SARS- CoV-2 pandemic). To ensure adequate recruitment and retention, the control group will receive a delayed intervention and participate in the monthly sessions during the second year of the study. Both groups will use continuous glucose monitoring (CGM) for 14 days every 3 months and complete surveys every 6 months. A1c will also be measured centrally every 6 months. We will compare the two groups on the primary glycemic outcome of percent time-in-range (TIR) of 70-180 mg/dL assessed by CGM and on the secondary outcomes of diabetes distress and A1c from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent TIR, diabetes distress, and A1c compared with the usual care control group.