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: 9982950
• 负责人: Naomi Sage Chaytor
• 金额: $ 65.73万
• 依托单位: JAEB CENTER FOR HEALTH RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-25 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9982950
• 关键词: Acute; Adult; Adverse effects; Age; Algorithms; Automation; Characteristics; Clinic; Clinical Trials; Cognition; Cross-Over Trials; Data; Devices; Diabetes Mellitus; Diabetic Ketoacidosis; Effectiveness; Elderly; Emergency department visit; Event; Family; Fracture; Fright; Glucose; Glycosylated hemoglobin A; Goals; Hospitalization; Hybrids; Hyperglycemia; Hypoglycemia; Impaired cognition; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Knowledge; Lead; Measures; Methods; Outcome; Outcome Measure; Participant; Patient Care; Patient Outcomes Assessments; Patient Preferences; Patients; Perception; Phase; Population; Prevention; Pump; Quality of life; Quality-of-Life Assessment; Randomized; Research; Running; Safety; Suspensions; System; Technology; Time; Training; Translating; Vulnerable Populations; Wireless Technology; age group; arm; automobile accident; clinical care; data registry; diabetes distress; diabetes management; effectiveness evaluation; efficacy evaluation; fall risk; falls; 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; safety outcomes; satisfaction; secondary outcome; sensor; societal costs; treatment arm; treatment comparison; trial design; usability

Project Summary/Abstract 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 proposed 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, age at least 65 years old, with T1D for at least 1 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.

项目摘要/摘要 减少低血糖是1型糖尿病管理的重要方面 老年人，其中许多人具有降血糖不认识，认知障碍或两者兼而有之。 现有的自动胰岛素输送系统的临床试验尚未包括老年人 足够的数字可以重点评估效率和生活质量的影响 与年龄段的年龄段观察到的不同。 拟议的研究名为“评估自动化的随机交叉试验 关于血糖结果和老年人的血糖结果和生活质量的胰岛素输送技术 1型糖尿病”旨在评估1）混合闭环技术的有效性 2）在血糖结果，QOL指标和 与传感器调节泵（SAP）疗法相比，可用性以及评估安全性 在这些技术中，在T1D的老年人中。次要目标是直接比较 HCl与PLG相同的结果。 这些目标将通过多中心，随机，跨界试验来实现，由 在三个12周期间的三个治疗臂，在一个期间使用HCL治疗臂 时期，一个时期使用的PLGS治疗组和SAP治疗组（对照）使用 在一个时期。跨界试验将在参与者的过程中进行磨合阶段 将接受有关使用研究设备的培训。随机试验将包括90个人 年龄至少65岁，T1D至少有1年的传感器证据 基线磨合期间低血糖。主要结果是与 在每个周期内，葡萄糖水平小于70 mg/dl。其他血糖指标，QOL 评估和系统可用性将是次要结果。严重的发生 低血糖，糖尿病性酮症酸中毒，跌倒/骨折，急诊室就诊和住院治疗 也将评估。跨审判之后，将有机会 使用研究设备额外12周来评估系统使用的选择（PLG与HCL）， 在更真实的环境中，长期耐用性和安全性和频率较低的研究联系人。 这是必须评估是否涉及更多高级技术的 胰岛素输送的自动化可以成功实施到糖尿病管理中 老年人。