Optimizing Self-Management Adherence and Glycemic Control in Older Teens with T1D

描述（由申请人提供）：尽管有许多新的药物和技术可以改善糖尿病自我管理和血糖控制（血糖[BG]水平），但慢性糖尿病并发症导致的残疾和过早死亡仍然很常见，突出了治疗进展与患者接受之间的差距。不遵守规定的糖尿病治疗是造成这一差距的重要原因，特别是在1型糖尿病（T1D）的弱势人群中，他们正在摆脱父母的照顾，在自我照顾方面变得更加独立。在此发育期间，血糖控制通常会随着血糖监测依从性的下降而恶化。纵向研究表明，青少年后期的不依从是血糖控制不良、多种身体和精神共病和过早死亡的危险因素。拟议项目的主要目的是通过激励14 - 17岁的T1D中老年人的自我护理行为来改善血糖控制，测量为血红蛋白A1c（A1c）（过去2 - 3个月的平均BG水平指数）。考虑到青少年中不依从性的复杂性和通常难以处理的性质，本申请提出设计、实施和评估旨在增加依从性（特别是对BG监测的依从性）和改善血糖控制的多方面干预。这些干预措施包括：（1）青少年行为工作（TW）干预，旨在通过提高自我效能进行血糖监测和糖尿病自我管理，（2）自动双向短信提醒以检查血糖水平（TX），或（3）两者（TW/TX）。拟议的项目扩展了我们以前在学龄儿童和青少年T1D中验证的家庭团队干预，将其定制为T1D的中老年人，并建立在我们的双向短信提醒试点工作的基础上，以增加血糖监测频率。青少年工作干预的重点是自我保健行为，并纳入青少年的定期季度糖尿病诊所访问。基于社会认知理论，本多PI R01随机对照临床试验将在2个大型糖尿病临床研究中心实施。我们提出了一种2x2析因设计，其中300名T1D持续时间为e1年且A1c水平为7 - 13%的中老年青少年将被随机分配到4组之一：TW，TX，TW/TX或标准治疗（SC）。在这项为期2年的研究中，主要结局将是4组中A1c从基线至12个月以及从12个月至24个月的变化。为确保招募和保留该风险人群，SC组将在12个月时交叉至TW/TX。TW、TX和TW/TX组将在12 - 24个月内继续接受各自的干预措施，以评估持久性。我们将评估血糖监测频率和A1C，以及其他用于模式合理性和冥想分析的指标。将收集有关干预措施成本和任何不良结果的数据，以评估干预措施是否能提高对血糖监测的依从性，并在准备过渡到青年和糖尿病自我护理时，以成本效益的方式改善中老年T1D青少年的A1c。

DESCRIPTION (provided by applicant): Despite many new medications and technologies to improve diabetes self-management and glycemic control (blood glucose [BG] levels), disability and premature mortality from chronic diabetes complications remain common, highlighting the gap between treatment advances and robust patient uptake. Non-adherence to prescribed diabetes treatment contributes significantly to this gap, especially in the vulnerable population o mid to older teens with type 1 diabetes (T1D) who are emerging from their parents' care and becoming more independent in their own self-care. During this developmental period, glycemic control often deteriorates as adherence to BG monitoring declines. Longitudinal studies reveal that non-adherence in late adolescence is a risk factor for poor glycemic control, multiple physical and psychiatric comorbidities, and premature mortality. The primary aim of the proposed project is to improve glycemic control, measured as hemoglobin A1c (A1c) (an index of average BG levels over the previous 2-3 months), by motivating self-care behaviors in mid to older teens with T1D, ages 14-17 years old. Given the complex and often intractable nature of non- adherence in adolescence, this application proposes to design, implement, and evaluate multi-faceted interventions aimed at increasing adherence, particularly to BG monitoring, and improving glycemic control. These interventions include: (1) a behavioral Teen work (TW) intervention targeting BG monitoring and diabetes self-management through increased self-efficacy, (2) automated 2-way text message reminders to check BG levels (TX), or (3) both (TW/TX). The proposed project extends our Family Teamwork intervention, previously validated in school-age children and young teens with T1D, by tailoring it to mid to older teens with T1D, and also builds on our pilot work of 2-way text message reminders to increase BG monitoring frequency. The Teen work intervention is focused on self-care behaviors and is integrated into the teen's regular quarterly diabetes clinic visits. Grounded in social cognitive theory, this multiple-PI R01 randomized controlled clinical trial will be implemented at 2 large diabetes clinical sites. We propose a 2x2 factorial design in which 300 mid to older teens with T1D duration of e1 year and A1c levels of 7-13% will be randomized to 1 of 4 groups: TW, TX, TW/TX, or Standard Care (SC). In this 2-year study, the primary outcome will be change in A1c from baseline to 12 months across the 4 groups, as well as from 12 to 24 months. To ensure recruitment and retention of this at-risk population, the SC group will cross-over to TW/TX at 12 months. The TW, TX, and TW/TX groups will continue to receive their respective interventions in months 12-24 to assess durability. We will assess BG monitoring frequency and A1C, as well as other measures for mode rational and meditational analyses. Data will be collected on costs of the interventions and any adverse outcomes to assess if the interventions enhance adherence to BG monitoring and improve A1c cost-effectively in mid to older teens with T1D as they prepare to transition to young adulthood and diabetes self-care.