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 “评估自动胰岛素输送技术的随机交叉试验 关于1型糖尿病老年人的血糖结果和生活质量”（辅助） 减少低血糖是老年人1型糖尿病治疗的重要方面， 其中许多人具有低血糖不认识，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包括足够数量的老年人 为了重点评估效率和生活质量的影响，可能与之不同 在年龄段中观察到。 该研究名为“评估自动胰岛素输送的随机交叉试验 1型糖尿病老年人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）预测性的有效性 与血糖结果，QOL指标和可用性相比，低葡萄糖悬浮液（PLG） 使用传感器增强泵（SAP）治疗，并评估这些技术的安全性 在T1D的老年人中。次要目标是将HCl与PLG直接比较这些目标 相同的结果。 这些目标将通过多中心，随机，跨界试验实现，由三个 在三个12周期间的治疗臂，在一个时期内使用HCL治疗臂， 一个时期使用的PLGS治疗臂，以及在 一个时期。跨界试验将在一个淘汰阶段之前，参与者将收到 使用研究设备的培训。随机试验将包括90个人，至少年龄 65年，T1D至少有一年的传感器证据测量了低血糖症 在基线磨合期间。主要结果是葡萄糖水平花费的时间百分比较少 在每个时期内，超过70 mg/dl。其他血糖指标，QOL评估和系统可用性 将是次要结果。严重低血糖症，糖尿病性酮症酸中毒的发生 还将评估跌倒/骨折，急诊室就诊和住院治疗。跟随 交叉试验，将为参与者提供使用学习设备的机会，以额外12次 评估系统使用选择（PLG与HCL）的几周，长期耐用性和安全性 现实世界中的设置较少，研究触点较少。 这是必须评估更先进的技术是否涉及自动化的 胰岛素输送可以成功实施到老年人的糖尿病管理中。 招募由于共同的大流行而减慢了。截至2022年10月18日，总计90 参与者是随机的，其中36个仍然活跃。招聘在covid期间停滞不前 19大流行；此申请是为了完成参与者的随访，直到 2023年12月1日，随后有4个月的分析和关闭。