Artificial Pancreas - Adolescent Physiology and Psychology Longitudinal Evaluation (A.P. APPLE)

人工胰腺 - 青少年生理学和心理学纵向评估 (A.P. APPLE)

• 批准号: 10381710
• 负责人: MARC D BRETON
• 金额: $ 63.89万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10381710
• 关键词: Address; Adipose tissue; Adolescence; Adolescent; Age; Artificial Pancreas; Attenuated; Blood Glucose; Child; Complex; Conflict (Psychology); Control Groups; Data; Deterioration; Development; Diabetes Mellitus; Distress; Dose; Environment; Evaluation; Evolution; Family; Family Process; Family dynamics; Glucose; Glycosylated hemoglobin A; Goals; Group Affiliation; Hyperglycemia; Hypoglycemia; Injections; Insulin; Insulin Infusion Systems; Insulin Resistance; Insulin-Dependent Diabetes Mellitus; Intervention; Label; Link; Liver; Mental Depression; Modernization; Muscle; Natural History; Outcome; Participant; Peer Group; Pharmacology; Physiological; Physiological Processes; Physiology; Process; Psychology; Psychosocial Factor; Psychosocial Influences; Puberty; Quality of life; Randomized; Risk; System; Techniques; Technology; Testing; Time; Tracer; Universities; Virginia; Youth; adolescent health; blood glucose regulation; clinical care; diabetes control; diabetes distress; diabetes management; follow-up; glucose monitor; glycemic control; improved; innovation; insulin sensitivity; novel; pediatric patients; peer influence; provider factors; psychologic; psychosocial; psychosocial stressors; response; stable isotope; treatment as usual; trend; uptake

SUMMARY / ABSTRACT This project addresses what is perhaps the biggest challenge in the clinical care of Type 1 diabetes (T1D): the incredible rise in HbA1c levels seen during the adolescent age span of 11-15 years. This rise appears to be driven by physiologic changes (an increase in insulin resistance) that are not adequately addressed, in part because of psychosocial challenges (including family conflict, peer influence, and diabetes distress). We propose to follow adolescents longitudinally for two years, with assessment of these physiologic factors and exploratory aim following psychosocial factors, as well as testing a promising intervention in the artificial pancreas (AP). This study is titled A.P. APPLE for Artificial Pancreas Adolescent Physiology and Psychosocial Longitudinal Evaluation. We hypothesize that long-term use of an AP system (Tandem's Control-IQ, compared to Usual Care+CGM) will in part blunt the rise in HbA1c that is typically seen. However, even apart from testing this intervention, this project offers valuable observational data on the natural history of changes seen in participants in the control group. We will follow changes in insulin resistance by body compartment (liver vs. muscle/adipose tissue) during pubertal progression using stable-isotope triple-tracer mixed meal tests, revealing novel information about how puberty-related insulin resistance evolves over time by body compartment—as well as how the AP might respond to these changes. We will also follow key psychosocial processes of family conflict, peer influence, diabetes distress, depression and quality of life to evaluate their temporal relationships to sub- optimal control. Following these processes may help in the application of pharmacologic or psychologic approaches to improve adolescent control—either with or without AP use. Finally, we will follow modern markers of T1D control, including time-in-range and glycemic variability to document for providers how these factors change during pubertal progression and how they are related to physiologic and psychosocial changes. This study takes advantage of the University of Virginia Center for Diabetes Technology as an environment with expertise in each of the domains of glycemia, physiology and psychosocial factors—as well as development of an AP system that is effective in short-term trials at reducing HbA1c. The sub-optimal control during adolescence has gotten more pronounced in recent studies and contributes to long-term complications. This project will provide valuable clues about the durability of AP use among adolescents as well the contribution of rising insulin resistance and psychosocial barriers—with a long-term goal of improving control and long-term health of adolescents with T1D.

总结/摘要 该项目解决了可能是1型糖尿病（T1 D）临床护理中最大的挑战： 在11-15岁的青少年时期，HbA 1c水平出现了令人难以置信的上升。这种上升似乎是 部分由未得到充分解决的生理变化（胰岛素抵抗增加）驱动 由于心理社会挑战（包括家庭冲突，同伴影响和糖尿病困扰）。我们 建议对青少年进行为期两年的纵向跟踪，评估这些生理因素， 探索性的目标，以下心理社会因素，以及测试一个有前途的干预，在人工 胰腺（AP）。这项研究的标题是A. P. APPLE人工胰腺青少年生理和心理社会 纵向评价。 我们假设，长期使用AP系统（Tandem的Control-IQ，与患者护理+CGM相比） 将部分抑制通常可见的HbA 1c升高。然而，除了测试这种干预措施， 该项目提供了有价值的观察数据，了解对照组参与者的自然变化史。 组我们将按照体室（肝脏vs.肌肉/脂肪组织）跟踪胰岛素抵抗的变化 在青春期进展期间使用稳定同位素三示踪剂混合餐试验，揭示了新的信息 关于青春期相关的胰岛素抵抗如何随着时间的推移由身体分区演变-以及AP如何 可能会对这些变化做出反应。我们还将跟踪家庭冲突、同伴冲突、家庭暴力和家庭暴力等关键的心理社会过程。 影响，糖尿病困扰，抑郁和生活质量，以评估其时间关系， 最优控制遵循这些过程可能有助于药理学或心理学的应用。 改善青少年控制的方法-无论是否使用AP。最后，我们将遵循现代 T1 D控制的标志物，包括范围内时间和血糖变异性，以记录提供者如何 因素在青春期的发展变化，以及它们如何与生理和心理社会变化相关。 这项研究利用弗吉尼亚大学糖尿病技术中心作为环境， 在每个领域的专业知识，生理学和心理社会因素，以及 开发一种AP系统，在短期试验中有效降低HbA 1c。 在最近的研究中，青春期的次优控制变得更加明显，并有助于 长期并发症。该项目将提供关于AP使用的持久性的有价值的线索， 青少年以及胰岛素抵抗和心理障碍的增加的贡献-与长期 目标是改善T1 D青少年的控制和长期健康。