Minimizing Hypoglycemia in Adults with Type 1 Diabetes through an Integrated Mobile Health and Continuous Glucose Monitoring System

项目概要/摘要 2级低血糖（血糖<54 mg/dL）是一种医疗紧急情况，可导致意识混乱、心脏病、 心律失常甚至死亡这种危险的情况经常发生在1型糖尿病患者中 (T1D)，包括使用连续葡萄糖监测系统（CGMs）的那些。在以前的研究中， 研究人员使用CGMs确定了患者的信念，这些信念会干扰低血糖症的治疗。然而，在这方面， CGM使用者的治疗干扰信念仍有待评估， 这些信念在CGM用户中是需要的。这个项目的目标是全面评估信念， 干预成人T1 D CGM使用者的低血糖治疗，并开发一种新的行为干预 计划来解决这些信念，并尽量减少低血糖。混合方法技术可以指导 识别低血糖治疗干扰信念，并确定预测2级的信念 低血糖症的有针对性的干预发展。移动的健康（mHealth）技术可以与 CGM数据用于开发广泛可访问的、以患者为中心的实时干预措施，以解决治疗问题 干扰信仰中心假设：mHealth-CGM行为干预计划可以减轻信念 干扰低血糖治疗并减少T1 D CGM使用者的低血糖。目标：（1）获得 深入了解CGM用户干扰低血糖治疗的信念;（2）开发 一个mHealth短信程序，生成自动化的，实时的行为干预，以减轻 干扰低血糖治疗的信念;（3）评估可行性，可接受性和初步的 mHealth-CGM行为干预计划在降低飞行员低血糖行为中的有效性 临床试验候选人：Yu Kuei Lin，医学博士是一名内分泌学家和早期职业研究者， 目标是成为一名独立的调查员，确定和制定干预措施，以减少 糖尿病患者的低血糖管理和预防。他有着成功的设计历史， 开展低血糖调查研究和生物医学临床试验，但需要更多的高级培训 行为科学研究这个K-23奖项将为他提供识别障碍所需的独特技能 管理或预防低血糖，并制定和评估以患者为中心的有针对性的干预措施 通过mHealth提供的旨在优化低血糖管理和预防的计划。培训 目标：（1）获得进行定性和混合方法研究的技能;（2）获得以下技能 发展移动健康行为干预措施;（3）发展进行行为临床试验的专业知识。博士 林的培训将得到经验丰富，互补的导师和顾问，先进的 教学课程，并参加研究和职业发展研讨会和会议， 丰富的培训环境。NIDDK K-23奖将为林博士提供受保护的时间， 需要进行培训，以帮助所有糖尿病患者最大限度地减少低血糖，改善健康状况。

Project Summary / Abstract Level 2 hypoglycemia (blood glucose <54 mg/dL) is a medical emergency that can lead to confusion, cardiac arrhythmias, and even death. This dangerous condition occurs frequently in patients with type 1 diabetes (T1D), including those using continuous glucose monitoring systems (CGMs). In prior studies of patients not using CGMs, researchers identified patient beliefs that interfere with hypoglycemia treatment. However, treatment interfering beliefs in CGM users remain to be evaluated, and an intervention to impactfully address these beliefs among CGM users is needed. The goal of this project is to comprehensively evaluate beliefs that interfere with hypoglycemia treatment in adult T1D CGM users, and to develop a novel behavioral intervention program to address these beliefs and minimize hypoglycemia. Mixed methods techniques can guide identification of hypoglycemia treatment interfering beliefs, and determine those predictive of level 2 hypoglycemia for targeted intervention development. Mobile health (mHealth) technology can be linked to CGM data to develop widely accessible, patient-centered, real-time interventions to address treatment interfering beliefs. Central hypothesis: An mHealth-CGM behavioral intervention program can mitigate beliefs that interfere with hypoglycemia treatment and reduce hypoglycemia in T1D CGM users. Aims: (1) Acquire an in-depth understanding of CGM users’ beliefs that interfere with hypoglycemia treatment; (2) Develop an mHealth text messaging program that generates automated, real-time behavioral interventions to mitigate beliefs that interfere with hypoglycemia treatment; (3) Assess the feasibility, acceptability and preliminary efficacy of the mHealth-CGM behavioral intervention program in reducing hypoglycemia in a pilot behavioral clinical trial. Candidate: Yu Kuei Lin, MD is an endocrinologist and early career investigator with the career goal of becoming an independent investigator, identifying and developing interventions to mitigate barriers to hypoglycemia management and prevention in diabetes patients. He has a successful history of designing and conducting hypoglycemia survey studies and biomedical clinical trials, but needs more training in advanced behavioral science research. This K-23 award will provide him with unique skills necessary to identify barriers to managing or preventing hypoglycemia, and to develop and evaluate patient-centered, targeted intervention programs delivered through mHealth aimed at optimizing hypoglycemia management and prevention. Training Objectives: (1) Acquire skills in conducting qualitative and mixed methods research; (2) Gain skills in developing mHealth behavioral interventions; (3) Develop expertise in conducting behavioral clinical trials. Dr. Lin’s training will be supported by highly experienced, complementary mentors and advisors, advanced didactic coursework, and participation in research and career development seminars and meetings within a resourceful, enriching training environment. An NIDDK K-23 award will provide Dr. Lin the protected time and training needed to help all patients with diabetes minimize hypoglycemia and improve health outcomes.