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.

项目概要/摘要 “评估自动胰岛素输送技术的随机交叉试验 关于患有 1 型糖尿病的老年人的血糖结果和生活质量”（AIDE） 减少低血糖是老年人 1 型糖尿病管理的一个重要方面， 其中许多人患有低血糖症、认知障碍或两者兼而有之。临床试验 现有的自动胰岛素输送系统尚未覆盖足够数量的老年人 以便集中评估可能与这些影响不同的功效和生活质量影响 在较年轻的年龄组中观察到。 该研究题为“评估自动胰岛素输送的随机交叉试验” 关于患有 1 型糖尿病的老年人的血糖结果和生活质量的技术” 旨在评估 1) 混合闭环 (HCL) 技术和 2) 预测的有效性 低血糖混悬液 (PLGS) 对血糖结果、生活质量指标和可用性的比较 传感器增强泵（SAP）疗法，以及评估这些技术的安全性， 患有 T1D 的老年人。第二个目标是在这些方面直接比较 HCL 和 PLGS 相同的结果。 这些目标将通过一项多中心、随机、交叉试验来实现，该试验包括三个 三个 12 周周期的治疗组，其中一个周期使用 HCL 治疗组， 一个时期内使用的 PLGS 治疗组和一个时期内使用的 SAP 治疗组（对照） 一个时期。交叉试验之前将有一个磨合阶段，参与者将获得 使用学习设备的培训。该随机试验将包括 90 名年龄至少 65 岁，患有 T1D 至少一年，有传感器测量低血糖的证据 在基线磨合期间。主要结果是血糖水平较低的时间百分比 每个时期超过 70 mg/dl。其他血糖指标、生活质量评估和系统可用性 将是次要结果。发生严重低血糖、糖尿病酮症酸中毒、 跌倒/骨折、急诊室就诊和住院治疗也将受到评估。继 交叉试验，参与者将有机会使用研究设备额外 12 几周的时间来评估系统使用的选择（PLGS 与 HCL）、长期耐用性和安全性 现实世界的环境，学习接触的频率较低。 因此，有必要评估是否有更先进的技术涉及自动化 胰岛素输送可以成功地应用于老年人的糖尿病管理中。 受新冠疫情影响，招聘工作放缓。截至 2022 年 10 月 18 日，总数 90 名中的 70 名 参与者是随机的，其中 36 人仍然活跃。疫情期间招聘陷入停滞 19 流行病；该申请用于资助完成参与者的后续行动，直到 2023 年 12 月 1 日，之后有 4 个月的时间进行分析和收尾。