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) 临床护理中可能面临的最大挑战： 在 11 至 15 岁的青少年时期，糖化血红蛋白 (HbA1c) 水平令人难以置信地上升。这次上涨似乎是 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，评估这些生理因素和 遵循心理社会因素的探索性目标，以及测试人工干预的有前途的干预措施 胰腺（AP）。这项研究的标题是 A.P. APPLE for Artificial Pancreas Adolescent Physiology and Psychosocial 纵向评估。 我们假设长期使用 AP 系统（Tandem 的 Control-IQ，与 Usual Care+CGM 相比） 会在一定程度上抑制通常出现的 HbA1c 升高。然而，即使除了测试这种干预之外， 项目提供了有关控制参与者所见变化的自然历史的有价值的观察数据 团体。我们将跟踪身体部位（肝脏与肌肉/脂肪组织）的胰岛素抵抗变化 在青春期进展期间使用稳定同位素三重示踪剂混合膳食测试揭示新信息 关于青春期相关的胰岛素抵抗如何通过身体部位随时间演变，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、同伴冲突等关键社会心理过程。 影响、糖尿病困扰、抑郁和生活质量，以评估其与亚健康的时间关系 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 改善青少年控制力的方法——无论是否使用 AP。最后，我们将遵循现代 T1D 控制标志物，包括时间范围和血糖变异性，以便为提供者记录这些 青春期进展过程中因素的变化以及它们与生理和心理变化的关系。 本研究利用弗吉尼亚大学糖尿病技术中心作为环境 拥有血糖、生理学和心理社会因素各个领域的专业知识，以及 开发可在短期试验中有效降低 HbA1c 的 AP 系统。 在最近的研究中，青春期的次优控制变得更加明显，并导致 长期并发症。该项目将为了解 AP 使用的持久性提供有价值的线索 青少年以及不断上升的胰岛素抵抗和社会心理障碍的影响——长期来看 改善 T1D 青少年的控制和长期健康的目标。