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.

1型糖尿病（T1D）的老年人患低血糖和高血糖的风险增加 导致严重的健康后果，例如癫痫发作，跌落和心肌梗死。护理伙伴（例如， 配偶，朋友）经常成为糖尿病护理团队的一部分，以协助自我管理 糖尿病年龄。糖尿病患者及其护理的人可以使用的技术进步 解决有害低血糖和高血糖的合作伙伴是使用连续的葡萄糖监测（CGM）， 使用数据共享应用程序，该应用程序允许老年人患有T1D及其护理伙伴（Dyad）查看葡萄糖数据 在其智能手机上，并在低血糖或高血糖发生之前收到警报。我们的长期目标 是利用技术和护理伙伴干预措施的全部潜力来优化护理的支持 合作伙伴可以为患有T1D的老年人提供有效的葡萄糖管理。我们的总体目标是测试 旨在改善糖尿病患者之间数据共享的使用，旨在改善数据共享的干预措施 以及他们的护理伙伴，以最大程度地利用CGM的好处。份额加干预提供 向当前CGM用户的说明如何设置数据共享应用程序，二元通信和问题 解决，以及如何为T1D及其护理伙伴的老年人制定数据共享行动计划。 我们的中心假设是，共享加上将导致时间增加和减少糖尿病困扰 与对照组相比，两个患有糖尿病（PWD）及其护理伙伴（CPS）的人（CPS）。这 这项试点研究的理由是，证明股份的功效加上将为一个新的机会 临床上有用的方法来增加葡萄糖范围的时间并减少老年人的糖尿病困扰 与T1D及其护理伙伴。中央假设将通过追求三个具体目标来检验：1） 与对照组相比，评估股份的可行性，可用性和可接受性以及干预措施 接受糖尿病自我管理教育的数据共享，2）评估股份的影响 干预时间内和糖尿病困扰，3）探索PWD中组之间的差异 以及CP二元评估和应对，生活质量，糖尿病自我保健和护理伙伴负担。测试我们的 中心假设，我们将在已经使用T1D的老年人中进行随机分配1：1对照试验 CGM（n = 80个二元组）以远程医疗格式，干预组将获得数据共享和共享 另外，对照组将接受糖尿病自我管理教育和协助设置数据 共享应用。该试验将包括一项为期12周的主动干预措施，以确定主要结果的变化 以及一个为期12周的观察阶段，以确定变化的维持。这项研究提出了 应用具有创新性，因为它提供了与现状相比的必要和实质性偏离。 使用数据共享技术带来了T1D管理的二元观点。