A Randomized Cross-Over Trial Evaluating Automated Insulin Delivery Technologies on Glycemic Outcomes and Quality of Life in Older Adults with Type 1 Diabetes

一项随机交叉试验，评估自动胰岛素输送技术对患有 1 型糖尿病的老年人的血糖结果和生活质量的影响

• 批准号: 10734496
• 负责人: Naomi Sage Chaytor
• 金额: $ 23.9万
• 依托单位: JAEB CENTER FOR HEALTH RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-04 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10734496
• 关键词: Acute; Adopted; Adult; Adverse effects; Age; Algorithms; Automation; COVID-19 pandemic; Characteristics; Clinic; Clinical Trials; Cognition; Continuous Glucose Monitor; Cross-Over Trials; Data; Devices; Diabetes Mellitus; Diabetic Ketoacidosis; Effectiveness; Elderly; Emergency department visit; Event; Family; Fracture; Fright; Funding; Glucose; Glycosylated hemoglobin A; Goals; Hospitalization; Hybrids; Hyperglycemia; Hypoglycemia; Impaired cognition; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Knowledge; Measures; Methods; Outcome; Outcome Measure; Participant; Patient Care; Patient Outcomes Assessments; Patient Preferences; Patients; Perception; Phase; Population; Prevention; Pump; Quality of Life Assessment; Quality of life; Randomized; Research; Running; Safety; Suspensions; System; Technology; Time; Training; Translating; Vulnerable Populations; age group; aged; arm; automobile accident; clinical care; data registry; diabetes distress; diabetes management; effectiveness evaluation; efficacy evaluation; fall risk; falls; follow-up; glucose monitor; glycemic control; human old age (65+); hypoglycemia unawareness; improved; indexing; innovation; mental state; mortality; older patient; preference; primary endpoint; primary outcome; psychosocial; randomized trial; recruit; safety outcomes; satisfaction; secondary outcome; sensor; societal costs; treatment arm; treatment comparison; trial design; usability; wireless

Project Summary/Abstract “A Randomized Cross-Over Trial Evaluating Automated Insulin Delivery Technologies on Glycemic Outcomes and Quality of Life in Older Adults with Type 1 Diabetes” (AIDE) Reducing hypoglycemia is an important aspect of management of type 1 diabetes in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. Clinical trials of existing automated insulin delivery systems have not included older adults in sufficient numbers to allow for focused evaluation of efficacy and quality of life impacts that may differ from those observed in younger age groups. The research entitled “A Randomized Cross-over Trial Evaluating Automated Insulin Delivery Technologies on Glycemic Outcomes and Quality of Life in Older Adults with Type 1 Diabetes” aims to evaluate the effectiveness of 1) hybrid closed loop (HCL) technology and 2) predictive low-glucose suspension (PLGS) on glycemic outcomes, QOL indicators and usability compared with sensor-augmented pump (SAP) therapy, as well as evaluate the safety of these technologies, in older adults with T1D. A secondary objective is to directly compare HCL with PLGS on these same outcomes. These aims will be achieved via a multi-center, randomized, crossover trial, consisting of three treatment arms over three 12-week periods, with the HCL treatment arm used during one period, the PLGS treatment arm used during one period and SAP treatment arm (control) used during one period. The crossover trial will be preceded by a run-in phase in which participants will receive training on using the study devices. The randomized trial will include 90 individuals, aged at least 65 years, with T1D for at least one year who have evidence of sensor measured hypoglycemia during the baseline run-in. The primary outcome is percent of time spent with glucose levels less than 70 mg/dl during each period. Other glycemic metrics, QOL assessments and system usability will be secondary outcomes. Occurrences of severe hypoglycemia, diabetic ketoacidosis, falls/fractures, emergency room visits, and hospitalizations also will be assessed. Following the cross-over trial, participants will be given the opportunity to use study devices for an additional 12 weeks to assess choice of system use (PLGS vs. HCL), long-term durability and safety in a more real-world setting with less frequent study contacts. Thus, it is imperative to assess whether more advanced technologies involving automation of insulin delivery can be successfully implemented into diabetes management of older adults. Recruitment was slowed due to the COVID pandemic. As of October 18th, 2022, 70 of the total 90 participants are randomized, 36 of which are still active. Recruitment stalled during the COVID- 19 pandemic; this application is for funding to complete the follow-up of participants until December 1st, 2023, with 4 months for analysis and closeout afterward.

项目摘要/摘要 “一项评估自动化胰岛素给药技术的随机交叉试验 老年1型糖尿病患者的血糖结果和生活质量“(AIDE) 降低低血糖是管理老年人1型糖尿病的一个重要方面， 他们中的许多人有低血糖意识障碍，认知障碍，或两者兼而有之。临床试验 现有的胰岛素自动给药系统没有包括足够多的老年人 允许集中评估疗效和生活质量影响，这些影响可能不同于 在较年轻的年龄组中观察到。 一项题为《评估自动化胰岛素给药的随机交叉试验》的研究 关于老年1型糖尿病患者血糖结果和生活质量的技术 旨在评估1)混合闭环系统(HCL)技术和2)预测技术的有效性 低糖混悬液(PLGS)对血糖、生活质量指标和易用性的影响比较 使用传感器增强型泵(SAP)治疗，以及评估这些技术的安全性， 在患有T1D的老年人中。第二个目标是直接比较HCL和PLGS在这些方面的差异 同样的结果。 这些目标将通过一项多中心、随机、交叉试验来实现，该试验由三个 三个为期12周的治疗臂，其中一个疗程使用氯化氢治疗臂， 在一个疗程中使用PLGS治疗臂，在一个疗程中使用SAP治疗臂(对照) 只有一个时期。交叉试验之前将经过磨合阶段，参与者将在该阶段获得 关于使用学习设备的培训。这项随机试验将包括90名年龄至少为30岁的受试者。 65岁，T1D至少一年，有传感器测量的低血糖证据 在基线磨合过程中。主要结果是血糖水平较低的时间百分比 每期均大于70 mg/dl。其他血糖指标、生活质量评估和系统可用性 将是次要的结果。出现严重低血糖、糖尿病酮症酸中毒、 还将评估跌倒/骨折、急诊室就诊和住院情况。紧随其后的是 交叉试验，参与者将有机会使用额外的12个研究设备 数周时间评估系统使用选择(PLGS与HCL)、长期耐用性和安全性 学习接触较少的真实环境。 因此，必须评估更先进的技术是否涉及自动化 胰岛素释放可以成功地应用于老年人的糖尿病治疗。 由于COVID大流行，招募工作放缓。截至2022年10月18日，90个国家中的70个 参与者是随机的，其中36人仍然活跃。招聘在COVID期间停滞不前- 19大流行；这项申请是为了资助完成参与者的后续行动，直到 2023年12月1日，有4个月的时间进行分析和收尾。