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的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，这突出了治疗进步与患者接受之间的差距。不坚持糖尿病处方治疗是造成这一差距的重要原因，特别是在易受伤害的人群中，即患有1型糖尿病（T1D）的中老年青少年，他们正在摆脱父母的照顾，在自己的自我照顾方面变得更加独立。在这一发育时期，血糖控制往往随着BG监测依从性的下降而恶化。纵向研究表明，青春期晚期不坚持服药是血糖控制不良、多种身体和精神合并症以及过早死亡的危险因素。该项目的主要目的是通过激励14-17岁T1D青少年的自我护理行为，改善血糖控制，以血红蛋白A1c (A1c)（前2-3个月平均血糖水平的指数）来测量。鉴于青少年不依从性的复杂性和通常难以处理的性质，本应用建议设计、实施和评估旨在增加依从性的多方面干预措施，特别是对BG监测和改善血糖控制。这些干预措施包括：(1)通过提高自我效能来进行针对BG监测和糖尿病自我管理的青少年行为工作（TW）干预，(2)自动双向短信提醒检查BG水平（TX），或(3)两者兼而有之（TW/TX）。拟议的项目扩展了我们的家庭团队合作干预，之前在学龄儿童和患有T1D的青少年中得到了验证，通过将其定制为患有T1D的中老年青少年，并且还建立在我们的双向短信提醒试点工作的基础上，以增加BG监测频率。青少年工作干预的重点是自我照顾行为，并与青少年定期的季度糖尿病诊所就诊相结合。本研究以社会认知理论为基础，在2个大型糖尿病临床站点进行多pi R01随机对照临床试验。我们提出了一个2 × 2的析因设计，其中300名T1D持续时间为1年，A1c水平为7-13%的中老年青少年将被随机分为4组：TW、TX、TW/TX或标准护理（SC）。在这项为期2年的研究中，主要结果将是4组患者从基线到12个月以及从12个月到24个月的A1c变化。为了确保招募和保留这些高危人群，SC组将在12个月后转到TW/TX。TW组、TX组和TW/TX组将在12-24个月继续接受各自的干预措施，以评估其耐久性。我们将评估BG监测频率和A1C，以及模式理性和冥想分析的其他措施。将收集干预措施的成本和任何不良结果的数据，以评估干预措施是否能在准备过渡到青年成年期和糖尿病自我护理的中老年T1D青少年中增强对BG监测的依从性，并经济有效地改善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.