Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial (CONDOR TRIAL)

透析患者连续血糖监测克服血糖异常试验（CONDOR TRIAL）

• 批准号: 10587470
• 负责人: Kamyar Kalantar-Zadeh
• 金额: $ 31.4万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 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 2023-08-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10587470
• 关键词: 2 arm randomized control trial; Accounting; Address; Adult; Affect; Agreement; Anxiety; Arrhythmia; Blood; Blood Glucose; Blood Glucose Self-Monitoring; Cardiovascular system; Cessation of life; Chronic Kidney Failure; Clinical Trials; Coin; Complication; Continuous Glucose Monitor; Data; Devices; Diabetes Mellitus; Diabetic Nephropathy; Dialysis Solutions; Dialysis patients; Dialysis procedure; End stage renal failure; Endocrine System Diseases; Exposure to; Feasibility Studies; Food Access; Frequencies; Fright; Fructosamine; Future; Gluconeogenesis; Glucose; Glycemic Index; Glycosylated hemoglobin A; Health Expenditures; Hemodialysis; Hospitalization; Hyperglycemia; Hypoglycemia; Impairment; Insulin Resistance; Intervention; Kidney; Knowledge; Lead; Measurable; Measurement; Measures; Metabolism; Methods; Monitor; Myocardial Ischemia; Participant; Pathway interactions; Patient Outcomes Assessments; Patients; Peritoneal Dialysis; Pharmaceutical Preparations; Pilot Projects; Population; Publishing; Quality of life; Randomized, Controlled Trials; Research; Risk; Safety; Site; Stress; Surveys; Technology; Time; Training; Veterans; Well in self; cardiovascular health; cohort; comorbidity; diabetes distress; diabetes management; diabetic; experience; glycemic control; glycosylated serum albumin; health related quality of life; high risk; improved; indexing; insulin secretion; monitoring device; mortality risk; non-diabetic; novel; primary endpoint; psychological distress; secondary endpoint; study population; success; tool; treatment as usual; trial comparing

PROJECT SUMMARY/ABSTRACT Diabetes mellitus (DM) is the leading cause of chronic kidney disease (CKD), accounting for ~47% and ~39% of US incident and prevalent end‐stage kidney disease (ESKD) patients, respectively. Our published research has shown that hypoglycemia is a highly prevalent complication associated with higher death risk in diabetic kidney disease (DKD) patients. Diabetic hemodialysis (HD) patients are at heightened risk for hypoglycemia via multiple pathways, including 1) decreased renal gluconeogenesis, 2) impaired metabolism/ clearance of DM medications, 3) co-existing comorbidities, 4) limited in-center HD food access, and 5) intra- dialytic glucose shifts. Given the ill effects of hypoglycemia on the cardiovascular (CV) health (arrhythmia, myocardial ischemia) and psychological well-being (hypoglycemia fear, stress/anxiety) observed in non-CKD studies, and the poor survival of diabetic HD patients (<35% over 5 years) largely due to CV causes, there is an urgent unmet need to identify strategies that mitigate low glycemic complications in this population. One of the major barriers to optimal glycemic control in DKD has been the lack of access to a practical, reliable method for frequent glycemic assessment. In diabetic HD patients, conventional metrics (self- monitored blood glucose [SMBG], HbA1c) are dominantly used despite limitations in accuracy, convenience, and intermittent frequency. In contrast, continuous glucose monitoring (CGM) is a convenient, automated glycemic assessment method that has shown improved glycemic control and reduced hypoglycemia in non- CKD trials. While our pilot data of CGM in HD patients shows strong agreement with gold-standard blood glucose levels and superior identification of hypoglycemia, it remains uncertain as to whether CGM can improve glycemic control, reduce hypoglycemia, optimize patient-reported outcomes in this population. To address this knowledge gap, we propose this Multiple-PI R01 study in which we aim to conduct a parallel, two-arm randomized controlled trial (RCT) comparing real-time CGM using Dexcom G6 devices vs. usual care (SMBG 4-times/day) among 122 in-center HD patients with DM over a 12-week period. Our primary objective will be to determine the effects of CGM vs. usual care on glycemic control, defined by percent (%) of time in target glucose range (70-180 mg/dl). Our main and exploratory secondary objectives will be to determine the effects of CGM on CGM-indices of hypoglycemia, blood-based glycemic markers (HbA1c, glycated albumin, fructosamine), and patient-reported outcomes (health-related quality of life, diabetes distress, hypoglycemia fear). We will also evaluate feasibility endpoints by measuring CGM compliance during the intervention period and success/ease of implementing CGM training sessions among patients. This single- center pilot RCT is the critical first step in determining the feasibility, efficacy, and safety of CGM in diabetic HD patients, and it will provide the requisite preliminary data to inform the framework of future large-scale, multi- center corollary RCT’s with an expanded number of endpoints, participants, and sites.

项目摘要/摘要 糖尿病（DM）是慢性肾脏疾病（CKD）的主要原因，占约47％和 〜39％的美国事件和普遍的末期肾脏疾病（ESKD）患者。我们出版了 研究表明，低血糖是与较高的死亡风险相关的高度普遍并发症 糖尿病肾病（DKD）患者。糖尿病血液透析（HD）患者的风险增加 低血糖通过多种途径，包括1）改善肾脏肝脏发生，2）代谢受损 DM药物的清除，3）共存合并症，4）中心内部的高清食品获取和5） 透析葡萄糖的变化。鉴于低血糖对心血管（CV）健康的不良影响（心律不齐， 心肌缺血）和心理健康（低血糖恐惧，压力/焦虑）在非CKD中观察到 研究，糖尿病高清患者的存活不良（在5年内<35％）主要是由于CV原因 紧迫的未满足需要确定减轻该人群中低血糖并发症的策略。 DKD中最佳血糖控制的主要障碍之一是无法获得实用的， 可靠的经常血糖评估的方法。在糖尿病高清患者中，常规指标（自我 受监测的血糖[SMBG]，HBA1C）在准确性，便利性和 和间歇性频率。相反，连续葡萄糖监测（CGM）是一种方便的自动化 血糖评估方法已显示出血糖控制改善和非血糖降低非血糖 CKD试验。虽然我们在高清患者中CGM的试验数据与金标准的血液表现出很强的一致性 葡萄糖水平和低血糖的卓越鉴定，CGM是否可以 改善血糖控制，减少低血糖，优化该人群中患者报告的结果。 为了解决这一知识差距，我们提出了这项多重PI R01研究，我们旨在进行一次 使用Dexcom G6设备VS进行实时CGM的平行，两臂随机对照试验（RCT） 在12周内的122例中心HD患者中，通常的护理（SMBG 4倍/天）在12周内。我们的主要 目的是确定CGM与常规护理对血糖控制的影响，该影响由百分比（％）定义 目标葡萄糖范围（70-180 mg/dl）的时间。我们的主要和探索性次要目标是 确定CGM对血糖，血糖标志物（HBA1C，HBA1C， 糖化白蛋白，果糖胺）和患者报告的结果（与健康相关的生活质量，糖尿病 困扰，低血糖恐惧）。我们还将通过测量CGM合规性来评估可行性终点 干预期以及在患者中实施CGM培训课程的成功/易用性。这个单个 中心飞行员RCT是确定CGM在糖尿病高清的可行性，效率和安全性的关键第一步 患者，它将提供必要的初步数据，以告知未来大规模的多个大规模的框架 中心Colrollary RCT的终点，参与者和站点扩大。