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

通过集成移动健康和连续血糖监测系统最大限度地减少 1 型糖尿病成人的低血糖

• 批准号: 10455619
• 负责人: YU KUEI LIN
• 金额: $ 19.61万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10455619
• 关键词: Address; Adult; Applications Grants; Arrhythmia; Award; Behavior; Behavior Therapy; Behavioral Research; Behavioral Sciences; Belief; Blood Glucose; Cardiac; Cessation of life; Clinical; Clinical Trials; Complex; Confusion; Control Groups; Dangerousness; Data; Development; Devices; Diabetes Mellitus; Endocrinologist; Environment; Event; Face; Future; Glucose; Goals; Health; Health Technology; Hyperglycemia; Hypoglycemia; Impaired cognition; Insulin-Dependent Diabetes Mellitus; Intervention; Interview; K-Series Research Career Programs; Knowledge; Lead; Life; Link; Medical emergency; Mentors; Methods; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Patients; Persons; Prevention; Qualitative Research; Recording of previous events; Research; Research Methodology; Research Personnel; Research Project Grants; Resources; Risk; Self Management; Structure; Surveys; System; Techniques; Technology; Text Messaging; Time; Training; Work; arm; behavior change; behavioral clinical trial; behavioral health intervention; career; career development; cognitive function; design; diabetes self-management; evidence base; experience; glucose monitor; group intervention; improved; innovation; insight; intervention program; mHealth; meetings; mortality; novel; patient oriented; pilot test; prevent; primary outcome; programs; randomized trial; recruit; research and development; skills; tailored messaging; text messaging intervention; therapy development; time use

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.

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，可能导致精神错乱、心脏病、 这种危险的情况经常发生在 1 型糖尿病患者身上。 (T1D)，包括那些使用连续血糖监测系统 (CGM) 的患者。 使用连续血糖监测，研究人员发现了干扰低血糖治疗的患者信念。 CGM 用户的治疗干扰信念仍有待评估，以及有效解决的干预措施 CGM 用户的这些信念是必要的，该项目的目标是全面评估以下信念： 干扰成人 T1D CGM 用户的低血糖治疗，并开发一种新的行为干预措施 混合方法技术可以指导解决这些信念并尽量减少低血糖的计划。 识别低血糖治疗干扰信念，并确定那些预测 2 级的信念 低血糖有针对性的干预开发可以与移动医疗（mHealth）技术联系起来。 CGM 数据可用于开发可广泛访问、以患者为中心的实时干预措施来解决治疗问题 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 T1D CGM 用户的低血糖。 深入了解 CGM 用户干扰低血糖治疗的信念（2）制定； 一种移动医疗短信程序，可生成自动、实时的行为干预措施，以缓解 干扰低血糖治疗的信念； (3) 评估可行性、可接受性和初步结果 mHealth-CGM 行为干预计划在减少行为试点低血糖方面的功效 临床试验候选人：Yu Kuei Lin，医学博士是一位内分泌学家和早期职业研究者。 成为一名独立调查员的目标，确定并制定干预措施以减轻障碍 他在设计和预防糖尿病患者的低血糖方面拥有成功的历史。 低血糖调查正在进行研究和生物医学临床试验，但需要更多高级培训 这项 K-23 行为科学研究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 通过移动医疗提供的计划旨在优化低血糖管理和预防培训。 目标： (1) 获得进行定性和混合方法研究的技能； (2) 获得以下方面的技能： 开发移动医疗行为干预措施；(3) 培养进行行为临床试验的专业知识。 林的培训将得到经验丰富、互补的导师和顾问、高级 教学课程，以及参加研究和职业发展研讨会和会议 NIDDK K-23 奖项将为林博士提供受保护的时间和丰富的培训环境。 需要培训来帮助所有糖尿病患者最大限度地减少低血糖并改善健康结果。