Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Prescribing in High-Risk Older Patients with Type 2 Diabetes

基于连续血糖监测的干预措施为高危老年 2 型糖尿病患者安全处方胰岛素的实用临床试验

• 批准号: 10559099
• 负责人: RICHARD W GRANT
• 金额: $ 61.32万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10559099
• 关键词: Accident and Emergency department; Address; Admission activity; Adult; Adverse drug event; Age; Algorithms; American; Blood Glucose Self-Monitoring; California; Cardiovascular system; Caring; Cessation of life; Classification; Clinical; Clinical Trials Design; Complication; Continuous Glucose Monitor; Coupled; Dementia; Diabetes Mellitus; Diet; Dose; Education; Elderly; Electronic Health Record; Emergency department visit; Ethnic Origin; Event; Fingers; Fracture; Fright; Funding; Future; Glucose; Goals; Health Status; Health system; Heterogeneity; Hospitalization; Human Resources; Hyperglycemia; Hypoglycemia; Iatrogenesis; Impaired cognition; Incidence; Injections; Insulin; Insurance Carriers; Intervention; Investments; Measures; Medicare; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Observational Study; Patient Education; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Pharmacists; Physical activity; Population; Pragmatic clinical trial; Quality of life; Race; Randomized; Regimen; Research Proposals; Risk; Risk Factors; Safety; Self Efficacy; Specific qualifier value; Symptoms; System; Testing; Time; Training and Education; Validation; Veterans; active comparator; arm; care delivery; clinical effect; comorbidity; dementia risk; design; diabetes distress; dissemination strategy; efficacy evaluation; efficacy testing; falls; glucose monitor; glycemic control; health literacy; high risk; hypoglycemia unawareness; improved; innovation; integrated care; intervention program; mortality; novel; older patient; participant enrollment; patient oriented; patient safety; pragmatic trial; prevent; programs; randomized trial; randomized, clinical trials; risk prediction model; statistics; treatment arm; treatment as usual; treatment effect; trend; trial design

Abstract Hypoglycemia is a common and preventable complication of insulin treatment in type 2 diabetes (T2D) that increases dramatically with age. In older adults (age ≥ 75), hypoglycemia accounts for 20% of all Emergency Department admissions for adverse drug events (primarily due to insulin). Hypoglycemic episodes in older adults are also associated with increased incidence of fall-related fractures, cardiovascular events, cognitive decline and dementia, hospitalization, worse self-reported quality of life, and mortality. For patients with T2D requiring insulin, optimal dosing requires monitoring glucose levels and directional trends in the context of insulin type and dose, diet, physical activity, health status, and symptoms. Severe hypoglycemia can occur at any time when the insulin regimen does not match the corresponding patient needs. In older patients, frequent self-monitoring of blood glucose (SMBG) using traditional fingerstick checks are often not physically possible (nor desirable). Moreover, many older patients with long duration T2D have hypoglycemia unawareness (a potent risk factor for severe hypoglycemia) and/or fear of hypoglycemia (with corresponding reluctance to inject full insulin dose). The overarching goal of this R01 research proposal is to support safer management of insulin-requiring, older adults (age ≥ 75) with T2D at high risk of severe hypoglycemia. We will test the hypothesis that in these high-risk older adults with T2D, a group-based educational program that incorporates alarm- enabled continuous glucose monitoring (CGM) will reduce the incidence of severe hypoglycemia as defined by the American Diabetes Association as requiring active assistance from another person to administer resuscitative measures. AIM 1: We will conduct a 3-arm randomized, pragmatic clinical trial designed to test the efficacy of two intervention strategies, Arm 1 – Patient-only and Arm 2 - Patient + Pharmacist compared to Arm 3 – Usual Care within a large, integrated care delivery system (Kaiser Permanente Northern California). This 3-arm design allows us to examine the impact of two versions of CGM-based program implementation that require different levels of health system investment (i.e., patient-education and training with or without added clinical personnel). AIM 2: We will also examine heterogeneity of intervention treatment effects by clinical context (baseline glycemic control, concurrent comorbidity) and patient context (age, health literacy) to inform future adaptation and dissemination strategies. This safety-oriented intervention strategy incorporating alarm-enabled CGM provides the potential for a low-burden approach to helping high-risk patients reduce incidence of severe hypoglycemia. If successful, the RCT evidence from this study will support new models of care designed to improve patient safety and patient-centered outcomes for older adults with T2D.

抽象的 低血糖是 2 型糖尿病 (T2D) 胰岛素治疗的常见且可预防的并发症 随着年龄的增长，低血糖发生率急剧上升（≥ 75 岁）。 因药物不良事件（主要是低血糖）入院急诊。 老年人的发作也与跌倒相关骨折的发生率增加有关， 心血管事件、认知能力下降和痴呆、住院、自我报告质量较差 对于需要胰岛素的 T2D 患者，最佳剂量需要监测血糖。 胰岛素类型和剂量、饮食、身体活动、健康状况的水平和方向趋势， 当胰岛素治疗方案不匹配时，随时可能发生严重低血糖。 相应的老年患者需要频繁自我监测血糖（SMBG）。 使用传统的指尖采血检查通常在物理上是不可能的（也不可取）。 患有长期 T2D 的老年患者对低血糖不知情（严重的潜在危险因素） 低血糖）和/或对低血糖的恐惧（相应地不愿意注射全剂量的胰岛素）。 该 R01 研究提案的总体目标是支持对需要胰岛素的患者进行更安全的管理， 患有 T2D 的老年人（年龄 ≥ 75 岁）患有严重低血糖的高风险 我们将检验以下假设： 针对这些患有 T2D 的高危老年人，这是一项基于团体的教育计划，其中包含警报 启用连续血糖监测（CGM）将减少严重低血糖的发生率，因为 美国糖尿病协会将其定义为需要他人的积极帮助才能 实施复苏措施 目标 1：我们将进行一项 3 组随机、实用的临床试验。 旨在测试两种干预策略的有效性，第 1 组 - 仅患者和第 2 组 - 患者+ 药剂师与第 3 组的比较 – 大型综合护理服务系统中的常规护理 (Kaiser 北加州永久医院）。这种 3 臂设计使我们能够检查两个版本的影响。 基于 CGM 的计划，其实施需要不同水平的卫生系统投资（即 患者教育和培训（无论是否增加临床人员）：我们还将进行检查。 临床背景下干预治疗效果的异质性（基线血糖控制、并发 合并症）和患者背景（年龄、健康素养），为未来的适应和传播提供信息 这种以安全为导向的干预策略结合了启用警报的 CGM，提供了 潜在的低负担方法可以帮助高危患者减少严重疾病的发生 如果成功，这项研究的随机对照试验证据将支持新的护理模式。 旨在改善患有 T2D 的老年人的患者安全和以患者为中心的结果。