Share plus: Continuous Glucose Monitoring with Data Sharing in Older Adults with T1D and Their Care Partners

分享加：患有 T1D 的老年人及其护理伙伴的持续血糖监测和数据共享

• 批准号: 10660793
• 负责人: NANCY Ann ALLEN
• 金额: $ 30.77万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10660793
• 关键词: Address; Adopted; Adult Children; Age; Behavior; Caring; Cellular Phone; Chronic Disease; Clinical; Clinical Trials; Communication; Complications of Diabetes Mellitus; Continuous Glucose Monitor; Control Groups; Dangerousness; Data; Diabetes Mellitus; Disease; Education; Elderly; Enrollment; Friends; Glucose; Goals; Health; Hyperglycemia; Hypoglycemia; Instruction; Insulin-Dependent Diabetes Mellitus; Intervention; Knowledge; Maintenance; Measures; Mission; Modeling; Myocardial Infarction; National Institute of Diabetes and Digestive and Kidney Diseases; Older Population; Outcome; Persons; Phase; Pilot Projects; Problem Solving; Public Health; Quality of life; Randomized; Readiness; Research; Risk; Science; Seizures; Self Care; Self Management; Signal Transduction; Spouses; Technology; Testing; Time; United States National Institutes of Health; Work; age related; benefit sharing; clinically significant; comparison control; comparison intervention; control trial; coping; data sharing; diabetes distress; diabetes management; diabetes self-management; efficacy trial; experience; falls; group intervention; improved; innovation; mobile application; prevent; primary outcome; response; secondary outcome; telehealth; tool; transmission process; trend; usability

Older adults with type 1 diabetes (T1D) have an increased risk of hypoglycemia and hyperglycemia that can result in grave health consequences, such as seizures, falls, and myocardial infarctions. Care partners (e.g., spouses, friends) regularly become part of the diabetes care team to assist in self-management as a person with diabetes ages. A technological advancement that is available to people with diabetes and their care partners to address harmful hypoglycemia and hyperglycemia is to use continuous glucose monitoring (CGM), with a data-sharing app that allows the older adult with T1D and their care partner (dyad) to see glucose data on their smartphones and to receive an alert before hypoglycemia or hyperglycemia occurs. Our long-term goal is to leverage the full potential of technology and care partner interventions to optimize the support that care partners can provide for effective glucose management in older adults with T1D. Our overall objective is to test an intervention, called Share plus, aimed at improving the use of data sharing between persons with diabetes and their care partners in order to maximize the benefits of CGM. The Share plus intervention provides instruction to current CGM users about how to set up the data sharing app, dyadic communication and problem solving, and how to establish a data-sharing action plan for older adults with T1D and their care partners. Our central hypothesis is that Share plus will result in increased time-in-range and decreased diabetes distress for both persons with diabetes (PWD) and their care partners (CPs) compared to the control group. The rationale for this pilot study is that demonstrating the efficacy of Share plus will provide new opportunities for a clinically useful approach to increase time in glucose range and decrease diabetes distress among older adults with T1D and their care partners. The central hypothesis will be tested by pursuing three specific aims: 1) evaluate feasibility, usability, and acceptability of the Share plus intervention compared to the control group receiving data sharing with diabetes self-management education, 2) evaluate the effect of Share plus intervention on time-in-range and Diabetes Distress, and 3) explore the differences between groups in PWD and CP dyadic appraisal and coping, quality of life, diabetes self-care and care partner burden. To test our central hypothesis, we will conduct a pilot randomized 1:1 control trial in older adults with T1D already using CGM (N=80 dyads) in a telehealth format where the intervention group will receive data sharing and Share plus and the control group will receive diabetes self-management education and assistance setting up the data sharing app. The trial will include a 12-week active intervention to determine a change in primary outcomes and a 12-week observation-only phase to determine maintenance of changes. The research proposed in this application is innovative because it provides a needed and substantive departure from the status quo by bringing a dyadic perspective of T1D management using data-sharing technology.

老年1型糖尿病（T1D）患者发生低血糖和高血糖的风险增加， 导致严重的健康后果，例如癫痫、福尔斯和心肌梗塞。护理伙伴（例如， 配偶、朋友）定期成为糖尿病护理团队的一部分，以协助作为一个人进行自我管理 糖尿病的年龄。糖尿病患者及其护理可获得的技术进步 解决有害的低血糖和高血糖的方法是使用连续葡萄糖监测（CGM）， 使用数据共享应用程序，允许患有T1D的老年人及其护理伴侣（二人组）查看血糖数据 并在发生低血糖或高血糖之前接收警报。我们的长期目标 是充分利用技术和护理合作伙伴干预的潜力，以优化护理支持， 伴侣可以为老年T1D患者提供有效的葡萄糖管理。我们的总体目标是测试 一项名为Share plus的干预措施，旨在改善糖尿病患者之间数据共享的使用 和他们的护理伙伴，以最大限度地发挥CGM的好处。分享加干预提供了 指导当前CGM用户如何设置数据共享应用程序、二元通信和问题 解决问题，以及如何为患有T1D的老年人及其护理伙伴建立数据共享行动计划。 我们的中心假设是，分享加将导致增加的时间范围和减少糖尿病的痛苦 与对照组相比，糖尿病患者（PWD）及其护理伙伴（CP）。的 这项试点研究的理由是，证明Share Plus的功效将为 增加血糖范围时间和减少老年人糖尿病痛苦的临床有效方法 T1D患者及其护理伙伴。中心假设将通过追求三个具体目标来检验：1） 与对照组相比，评价Share plus干预的可行性、可用性和可接受性 接受糖尿病自我管理教育的数据共享，2）评价Share plus的效果 干预的时间范围和糖尿病困扰，3）探讨组间的差异，在PWD 慢性胰腺炎患者对慢性胰腺炎的评价和应对、生活质量、糖尿病自我护理和护理伙伴负担。来测试我们 中心假设，我们将在已经使用T1D的老年人中进行一项初步随机1：1对照试验， 远程医疗格式的CGM（N=80对），干预组将接收数据共享和共享 并与对照组进行糖尿病自我管理教育及协助建立资料 该试验将包括12周的积极干预，以确定主要结局的变化 以及为期12周的观察阶段，以确定是否维持变化。这项研究提出， 应用是创新的，因为它提供了一个必要的和实质性的脱离现状， 利用数据共享技术，从二元角度看待T1D管理。