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

项目总结/摘要 糖尿病（DM）是慢性肾脏病（CKD）的主要原因，约占47%， 约39%的美国新发和流行终末期肾病（ESKD）患者。我们的出版 研究表明，低血糖症是一种非常普遍的并发症， 糖尿病肾病（DKD）患者。糖尿病血液透析（HD）患者的风险增加， 多途径低血糖，包括1）肾脏新生血管减少，2）代谢受损/ DM药物清除，3）共存合并症，4）中心内HD食物获取受限，5）中心内 透析葡萄糖变化。鉴于低血糖对心血管（CV）健康的不良影响（心律失常， 心肌缺血）和心理健康（低血糖恐惧、压力/焦虑） 研究，以及糖尿病HD患者的生存率差（5年内<35%），主要是由于CV原因， 迫切需要确定减轻该人群低血糖并发症的策略。 DKD患者最佳血糖控制的主要障碍之一是缺乏实用的， 可靠的方法，频繁血糖评估。在糖尿病HD患者中，常规指标（自我评估） 监测的血糖[SMBG]，HbA 1c），尽管在准确性，方便性， 和间歇频率。相比之下，连续葡萄糖监测（CGM）是一种方便的自动化血糖监测方法。 血糖评估方法，已显示改善血糖控制和减少低血糖， CKD试验。虽然我们在HD患者中的CGM初步数据显示与金标准血液非常一致， 血糖水平和低血糖的上级识别，仍然不确定CGM是否可以 改善血糖控制，减少低血糖，优化该人群患者报告结局。 为了解决这一知识差距，我们提出了这项多PI R 01研究，我们的目标是进行一项 比较使用Dexcom G6器械与 在12周期间，122例中心HD DM患者接受常规治疗（SMBG 4次/天）。我们的首要 目的是确定CGM与常规护理对血糖控制的影响，定义为 目标血糖范围内的时间（70-180 mg/dl）。我们的主要和探索性的次要目标将是 确定CGM对低血糖症的CGM指数、基于血液的血糖标记物（HbA 1c， 糖化白蛋白、果糖胺）和患者报告的结局（健康相关生活质量、糖尿病 痛苦、低血糖恐惧）。我们还将通过测量CGM依从性来评估可行性终点， 在患者中实施CGM培训课程的干预期和成功/容易程度。这单- 中心试点RCT是确定CGM在糖尿病HD中的可行性、有效性和安全性的关键第一步 患者，它将提供必要的初步数据，为未来的大规模，多 中心推论RCT的终点、受试者和研究中心数量增加。

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.