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: 10402780
• 负责人: Naomi Sage Chaytor
• 金额: $ 56.58万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10402780
• 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; 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; wireless

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.

项目总结/摘要 减少低血糖是1型糖尿病管理的一个重要方面， 老年人，其中许多人患有低血糖无意识、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。 足够的数量，以便集中评估可能 与在年轻人中观察到的不同。 这项名为“一项随机交叉试验， 胰岛素给药技术对老年糖尿病患者血糖结果和生活质量的影响 1型糖尿病”旨在评估1）混合闭环（HCL）技术的有效性 和2）预测性低血糖暂停（PLGS）对血糖结果，QOL指标和 与传感器增强泵（SAP）治疗相比的可用性，以及评价安全性 这些技术，在老年人与T1 D。第二个目标是直接比较 HCL与PLGS在这些相同的结果。 这些目标将通过一项多中心、随机、交叉试验实现，包括 在3个12周周期内使用3个治疗组，其中1个周期内使用HCL治疗组 在一个阶段期间使用PLGS治疗组，在一个阶段期间使用SAP治疗组（对照）， 在一个时期。交叉试验之前将有一个磨合期，参与者 将接受关于使用研究器械的培训。随机试验将包括90名个体， 年龄至少65岁，患有T1 D至少1年，有探头测量证据 基线导入期低血糖。主要结果是花费的时间百分比 每个时期的葡萄糖水平低于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 低血糖、糖尿病酮症酸中毒、福尔斯/骨折、急诊室就诊和住院 也将被评估。在交叉试验之后，参与者将有机会 使用研究器械额外12周，以评估系统使用的选择（PLGS与HCL）， 在更真实的环境中具有长期耐用性和安全性，研究接触频率较低。 因此，必须评估是否有更先进的技术， 胰岛素输送的自动化可以成功地实施到糖尿病管理中， 老年人