iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

 描述(由申请人提供)：故意省略胰岛素以控制体重是1型糖尿病(T1D)临床治疗中的一个重要问题，与早期和严重的糖尿病相关的医学并发症和过早死亡有关。高达40%的患有T1D的年轻女性滥用胰岛素来控制体重，符合饮食失调(ED)的诊断标准。如果不使用胰岛素，人们就可以通过将葡萄糖排入尿液来进食、维持甚至减肥；然而，这也会导致死亡风险增加3到14倍。对患有EDS的T1D患者的治疗还不发达，也没有得到充分的研究。没有明确的证据表明，目前的策略改善了这一高危人群的代谢控制，治疗创新也有限，无法产生更令人信服的结果。我们收集了每天的即时数据，其中包括与故意遗漏胰岛素相关的想法、感觉和行为，以及增加T1D患者对ED症状易感性的因素(5R01 DK-089329-03)。这些数据为胰岛素遗漏的预测因素和相关性提供了新的见解，使我们能够针对这些患者群体量身定做治疗方案，并减少日常生活中胰岛素的滥用。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 时刻，更有效地应对。这是第一次在系统研究自然环境中故意遗漏胰岛素的基础上进行的治疗。因为干预是基于高度生态有效性的数据，它更有可能接触到关键的治疗目标。这也是第一次利用智能手机克服T1D管理的心理障碍的研究。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中。为了更快地将临床资源带给这一患者群体，我们将我们的创新治疗工具构建在现有的用于急救的移动应用程序Recovery Record的基础设施上。在目标1中，我们基于我们关于胰岛素遗漏触发因素的经验证据和来自T1D患者的定性反馈，将特定于T1D的内容构建到APP中。这款功能齐全的APP在有意省略胰岛素的T1D患者身上进行了Beta测试。在目标2中，我们测试APP支持的个体化治疗是否与代谢控制的改善、ED症状的减少和急诊护理的利用有关。我们还检查了应用程序使用频率和结果之间的对应关系，并计算了消耗量。项目成果包括(1)T1D患者可以使用的移动应用程序，可以减少故意的胰岛素遗漏，以及(2)将在更大的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经验性支持的治疗方法，帮助T1D患者减少威胁生命的胰岛素滥用，并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.