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: 10597623
• 负责人: MARC D BRETON
• 金额: $ 61.65万
• 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/10597623
• 关键词: Address; Adipose tissue; Adolescence; Adolescent; Age; Artificial Pancreas; Attenuated; Blood Glucose; Child; Complex; Conflict (Psychology); Continuous Glucose Monitor; 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; Physiological; Physiological Processes; Physiology; Process; Psychology; Psychosocial Factor; Psychosocial Influences; Puberty; Quality of life; Randomized; Recommendation; 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; glycemic control; improved; innovation; insulin sensitivity; novel; pediatric patients; peer influence; pharmacologic; 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.

摘要 /摘要 该项目解决了1型糖尿病（T1D）临床护理中最大的挑战： 在11-15岁的青少年年龄跨度时，HBA1C水平的令人难以置信的上升。这个上升似乎是 受生理变化（胰岛素抵抗的增加）驱动，部分无法适当解决 由于社会心理挑战（包括家庭冲突，同伴影响和糖尿病困扰）。我们 提议纵向跟随青少年两年，并评估这些生理因素和 探索性的目标是以心理社会因素为基础，并测试了对艺术的承诺干预措施 胰腺（AP）。这项研究的标题为A.P.苹果，用于人造胰腺青少年生理学和社会心理 纵向评估。 我们假设长期使用AP系统（与通常的护理+CGM相比，串联的Control-IQ） 通常会在某种程度上看到HBA1C的上升。但是，即使除了测试这种干预外， 项目提供了有关控制中参与者发生变化的自然历史的价值观察数据 团体。我们将遵循人体室胰岛素抵抗的变化（肝脏与肌肉/脂肪组织） 在青春期进展过程中，使用稳定 - 同位素三重追踪混合餐测试，揭示了新的信息 关于青春期相关的胰岛素抵抗如何随着人体隔室的时间演变而来 - 以及AP如何 也许会回应这些变化。我们还将遵循家庭冲突的关键社会心理过程，同伴 影响，糖尿病困扰，抑郁和生活质量，以评估其与子的临时关系 最佳控制。遵循这些过程可能有助于应用药理学或心理学 改善青少年控制的方法 - 无论是否使用AP使用。最后，我们将跟随现代 T1D控制的标记，包括用于文件的时间范围和血糖变异性，以便提供者如何 因素在青春期进展过程中的变化及其与生理和社会心理变化的关系。 这项研究利用弗吉尼亚大学糖尿病技术中心作为一种环境 在血糖，生理学和社会心理因素的每个领域中都有专业知识 在减少HBA1C的短期试验中有效的AP系统的开发。 在青少年期间的亚最佳控制在最近的研究中变得更加明显，并有助于 长期并发症。该项目将提供有关AP使用耐用性的宝贵线索 青少年以及胰岛素抵抗和社会心理障碍的贡献 - 长期 通过T1D改善青少年的控制和长期健康的目标。