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 降低低血糖是治疗1型糖尿病的一个重要方面 老年人，他们中的许多人有低血糖意识或认知障碍，或两者兼而有之。 现有的自动化胰岛素给药系统的临床试验还没有将老年人包括在内 足够的数字，以便集中评估疗效和生活质量影响，这可能 与年轻人群中观察到的不同。 一项题为《自动化随机交叉试验评价》的拟议研究 胰岛素给药技术对老年糖尿病患者血糖结局和生活质量的影响 1型糖尿病“旨在评估1)混合闭环(HCL)技术的有效性 2)预测低糖混悬液(PLGS)对血糖结果、生活质量指标和 与传感器增强泵(SAP)疗法的易用性进行比较，并评估其安全性 在这些技术中，有T1D的老年人。第二个目标是直接比较 HCL和PLGS对这些结果的影响。 这些目标将通过多中心、随机、交叉试验来实现，该试验包括 在三个12周的周期内使用三个治疗臂，在一个疗程中使用盐酸治疗臂 期间，PLGS治疗臂在一个周期内使用，SAP治疗臂(对照)使用 在一段时期内。交叉试验之前将有一个磨合阶段，参与者 将接受使用学习设备的培训。这项随机试验将包括90名个体， 年龄至少65岁，T1D至少1年，有传感器测量的证据 在基线磨合期间出现低血糖。主要结果是花费时间的百分比 每一时期的血糖水平均低于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结果。严重中毒事件的发生 低血糖、糖尿病酮症酸中毒、跌倒/骨折、急诊室就诊和住院 也将进行评估。交叉试验后，参与者将有机会 再使用研究设备12周来评估系统使用的选择(PLGS与HCL)， 长期耐用性和安全性，在更真实的环境中，学习接触较少。 因此，必须评估更先进的技术是否涉及 胰岛素注射自动化可以成功地应用于糖尿病的治疗 上了年纪的人。