Function and Emotion in Everyday Life with Type 1 Diabetes: FEEL-T1D

项目摘要/摘要 情绪幸福感和日常生活功能是1型糖尿病患者的重要结局 也是整体生活质量的有力贡献者。各种情绪困扰的指标(例如，消极的 情绪、抑郁症状、糖尿病痛苦)在患有T1D的人中升高。同样，函数或 进行必要或期望的日常生活活动的能力也受到不利影响：低血压和 高血糖和T1D自我管理任务会扰乱日常工作、休闲和社交活动 T1D患者的活动。而急性血糖水平和变异性被认为是导致 患有T1D的人功能和幸福感降低，这些关系鲜为人知。糖尿病 到目前为止的研究主要依赖于对血糖、功能和 情感幸福感，无法捕捉到他们在日常生活中展开的复杂动态关系 上下文。为了克服这一限制，1型糖尿病患者日常生活中的功能和情绪(感觉- T1D)研究是第一个将连续血糖监测(CGM)、加速度计和 生态瞬时评估(EMA)解开血液之间的短期动态关系 成人1型糖尿病患者的血糖、功能和情绪健康状况。 在Feel-T1D研究中，200名患有T1D的成年人将完成一组基线调查，随后14天 使用盲目CGM和EMA调查进行密集的纵向数据收集，动态认知 任务和加速度计的磨损。这些工具将用于评估血糖、情绪幸福感(压力、 积极和消极情绪、糖尿病痛苦)、功能(自我报告的活动表现、客观认知 功能、体力活动)，以及可能调节或混淆感兴趣的关系的协变量。多重 表征血糖的指标(急性血糖水平、血糖漂移、血糖变异性和% 血糖范围内的时间)将从CGM数据中导出，以确定哪些最显著 在短期和日常的基础上与幸福感和功能的关系。通过澄清哪些内容 血糖指标与临床和患者报告的结果最密切相关，这些分析将 为个性化治疗建议奠定基础，并导致 创新的及时适应性干预措施，以应对最有效的健康和福祉预测因素。 这项研究的具体目标如下：目标1：了解人与人之间的动态关系 血糖指标、功能和情绪幸福感，通过使用CGM的多水平时间序列分析， EMA和加速度计数据。目标2：检查短期和日常关系的主持人，例如 人口学、临床特征和糖化血红蛋白，血糖指标、功能和情绪之间的关系 幸福。目标3：了解血糖指标、功能和血糖之间的短期动态 情绪幸福感是全球功能、幸福感和生活质量的预测指标。

PROJECT SUMMARY/ABSTRACT Emotional well-being and everyday life function are important outcomes for people with type 1 diabetes (T1D) and are robust contributors to overall quality of life. Various indicators of emotional distress (e.g., negative mood, depressive symptoms, diabetes distress) are elevated in people with T1D. Likewise, function, or the ability to perform necessary or desired daily life activities, is also adversely impacted: symptoms of hypo- and hyperglycemia and T1D self-management tasks can disrupt participation in everyday work, leisure, and social activities among people with T1D. While acute blood glucose levels and variability are thought to contribute to diminished function and well-being in people with T1D, these relationships are poorly understood. Diabetes research to date has primarily relied on global, retrospective measures of blood glucose, function and emotional well-being that cannot capture their complex dynamic relationships as they unfold in everyday life contexts. To overcome this limitation, the Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL- T1D) study is the first large-scale study to integrate continuous glucose monitoring (CGM), accelerometry, and ecological momentary assessment (EMA) to disentangle the short-term dynamic relationships between blood glucose, function, and emotional well-being in adults with type 1 diabetes. In the FEEL-T1D study, 200 adults with T1D will complete a baseline survey battery followed by 14 days of intensive longitudinal data collection using blinded CGM coupled with EMA surveys, ambulatory cognitive tasks, and accelerometer wear. These tools will be used to assess blood glucose, emotional well-being (stress, positive and negative affect, diabetes distress), function (self-reported activity performance, objective cognitive function, physical activity), and covariates that may moderate or confound the relationships of interest. Multiple metrics characterizing blood glucose (acute glucose level, glycemic excursions, glycemic variability, and % time in glycemic ranges) will be derived from CGM data to determine which have the most pronounced relationships with well-being and function on both a short-term and day-to-day basis. By clarifying which metrics of blood glucose are most closely related to clinical and patient-reported outcomes, these analyses will be foundational to the individualization of treatment recommendations and lead to the development of innovative just-in-time adaptive interventions to address the most potent predictors of health and well-being. The study's specific aims are as follows: Aim 1: Understand within-person dynamic relationships between blood glucose metrics, function, and emotional well-being through multi-level time-series analyses using CGM, EMA, and accelerometer data. Aim 2: Examine moderators of short-term and daily relationships, such as demographics, clinical characteristics, and HbA1c, between blood glucose metrics, function, and emotional well-being. Aim 3: Understand how short-term dynamics between blood glucose metrics, function, and emotional well-being are predictive of global function, well-being, and quality of life.