iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

 描述（由申请方提供）：在1型糖尿病（T1 D）的临床管理中，为控制体重而故意遗漏胰岛素是一个重要问题，与早期和重度糖尿病相关医学并发症和过早死亡相关。高达40%的T1 D年轻女性滥用胰岛素来控制体重，符合进食障碍（艾德）的诊断标准。省略胰岛素使个体能够进食并通过将葡萄糖排泄到尿液中来维持甚至减轻体重;然而，它也导致死亡风险增加3至14倍。对于患有ED的T1 D患者的治疗尚不成熟且研究不足。没有明确的证据表明，目前的策略可以改善这一高风险人群的代谢控制，并且治疗创新有限，无法产生更令人信服的结果。我们收集了与故意胰岛素遗漏相关的想法、感受和行为的日常即时数据，以及增加T1 D患者对艾德易感性的因素（5 R 01 DK-089329-03）。这些数据提供了关于胰岛素遗漏的预测因子和相关性的新见解，使我们能够为患者群体量身定制治疗并减少日常生活中的胰岛素滥用。在目前的项目中，我们将这些新发现转化为一种创新的治疗策略，该策略使用智能手机多媒体应用程序（app）来帮助个人识别他们在治疗过程中胰岛素滥用的触发因素。 更有效地应对和科普。这是第一个基于在自然环境中故意遗漏胰岛素的系统研究的治疗方法。由于干预措施是基于高度生态有效的数据，因此更有可能涉及关键的治疗目标。这也是第一项利用智能手机克服T1 D管理心理障碍的研究。在最需要的时间和地点向患者提供干预可能是实现行为改变的更有效和更高效的策略，并允许患者更容易将技能推广到他们的家庭环境。为了更快地将临床资源提供给这一患者群体，我们在现有的ED移动的应用程序Recovery Record的基础上构建了我们的创新治疗工具。在目标1中，我们根据我们的经验证据，将T1 D特定内容构建到应用程序中，这些证据是胰岛素遗漏的触发因素和T1 D患者的定性反馈。这款功能齐全的应用程序在有意省略胰岛素的T1 D患者中进行了beta测试。在目标2中，我们测试了应用程序支持的个体化治疗是否与改善代谢控制和减少艾德症状和紧急护理利用相关。我们还检查了应用程序使用频率与结果之间的对应关系，并计算了流失率。项目可交付成果包括（1）T1 D患者可访问的移动的应用程序，可减少故意胰岛素遗漏，以及（2）将在更大规模临床试验中测试的治疗胰岛素滥用的程序。这项研究的长期目标是建立一种药物支持的治疗方法，帮助T1 D患者减少危及生命的胰岛素滥用，保持寿命和生活质量。

 DESCRIPTION (provided by applicant): Intentional insulin omission for weight control is a significant problem in the clinical management of type 1 diabetes (T1D), associated with early and severe diabetes-related medical complications and premature death. Up to 40% of young women with T1D misuse insulin to control weight, meeting diagnostic criteria for an eating disorder (ED). Omitting insulin allows individuals to eat and maintain or even lose weight by excreting glucose into the urine; however, it also contributes to a 3 to 14-fold increase in mortality risk. Treatments for T1D patients with EDs are underdeveloped and understudied. There is no clear evidence that current strategies improve metabolic control in this high-risk population, and there has been limited treatment innovation to produce more compelling outcomes. We have collected daily, in-the-moment data on thoughts, feelings, and behaviors that are associated with intentional insulin omission, as well as factors that increase T1D patients' vulnerability to ED symptomatology (5R01 DK-089329-03). These data provide new insights on predictors and correlates of insulin omission that allow us to tailor treatments to thi patient population and reduce insulin misuse in daily life. In the current project, we translate these emerging findings into an innovative treatment strategy that uses a smartphone multimedia application (app) to help individuals recognize their triggers for insulin misuse in-the moment and cope more effectively. This is the first treatment that is based on the systematic study of intentional insulin omission in the natural environment. Because the intervention is based on data that are highly ecologically valid, it is more likely to engage critical treatment targets. This is also the first study to leverage smartphones to overcome psychological barriers to T1D management. Delivering intervention to patients at the time and place when it is most needed may be a more effective and efficient strategy to achieve behavior change, and allow patients to more readily generalize skills to their home environment. In order to more swiftly bring clinical resources to this patient population, we build our innovative treatment tool on the infrastructure of an existing mobile app for EDs, Recovery Record. In Aim 1, we build T1D-specific content into the app based on our empirical evidence of triggers for insulin omission and qualitative feedback from T1D patients. The fully functional app is beta tested with T1D patients who intentionally omit insulin. In Aim 2, we test whether app-supported individual treatment is associated with improved metabolic control and a decrease in ED symptoms and emergency care utilization. We also examine correspondence between frequency of app use and outcomes and calculate attrition. Project deliverables include (1) a mobile app that is accessible to T1D patients that may reduce intentional insulin omission, and (2) procedures for treating insulin misuse to be tested in a larger clinical trial. The long-term goal of this research is to establishan empirically-supported treatment that helps T1D patients reduce life-threatening insulin misuse and preserve longevity and quality of life.