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型糖尿病中胰岛素治疗的常见并发症（T2D） 这会随着年龄的增长而大大增加。在老年人（年龄≥75岁）中，低血糖占所有的20％ 广告药物事件的急诊科入学（主要是由于胰岛素）。降血糖 老年人的发作也与秋天相关骨折事件增加有关， 心血管事件，认知能力下降和痴呆，住院，自我报告的质量较差 生活和死亡率。对于需要胰岛素的T2D患者，最佳给药需要监测葡萄糖 在胰岛素类型和剂量，饮食，体育锻炼，健康状况， 和符号。胰岛素方案不匹配的任何时候都可能发生严重的低血糖 相应的患者需要。在老年患者中，血糖（SMBG）经常自我监测 使用传统的指尖检查通常在身体上是不可能的（也不理想的）。而且，许多 持续时间长的老年患者T2D患有低血糖不认识（严重的潜在危险因素 低血糖）和/或对低血糖的恐惧（相应地不愿注入全胰岛素剂量）。 这项R01研究建议的总体目标是支持更安全的胰岛素重新管理， 老年人（年龄≥75岁），T2D患有严重低血糖症的高风险。我们将检验以下假设 这些高风险的老年人与T2D，这是一个基于小组的教育计划，结合了警报 - 启用的连续葡萄糖监测（CGM）将减少严重低血糖症的发生率 由美国糖尿病协会定义为需要另一个人的积极帮助 管理复苏测量。目标1：我们将进行3臂随机，务实的临床试验 旨在测试两种干预策略的效率，即ARM 1 - 仅患者和手臂2 - 患者 + 与ARM 3相比，药剂师 - 大型集成护理系统中的通常护理（Kaiser 北加州的永久性）。这种3臂设计使我们能够检查两个版本的影响 基于CGM的计划实施需要不同水平的卫生系统投资（即 有或没有增加临床人员的患者教育和培训）。目标2：我们还将检查 干预治疗效果的异质性通过临床环境（基线血糖控制，并发） 合并症）和患者环境（年龄，健康素养），以告知未来的适应和传播 策略。这种以安全为导向的干预策略结合了支持警报的CGM 潜在的低责任方法来帮助高危患者降低严重的发生率 低血糖。如果成功，本研究的RCT证据将支持新的护理模型 旨在改善T2D老年人的患者安全性和以患者为中心的结果。