Use of Continuous Glucose Monitoring (CGM) in End-Stage Renal Disease (ESRD) Patients with Type 2 Diabetes

连续血糖监测 (CGM) 在患有 2 型糖尿病的终末期肾病 (ESRD) 患者中的应用

• 批准号: 10327284
• 负责人: Rodolfo Galindo
• 金额: $ 18.94万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-15 至 2024-12-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10327284
• 关键词: Advisory Committees; Affect; Arrhythmia; Bioinformatics; Biometry; Blinded; Blood Glucose; Blood capillaries; Clinical Research; Comparative Study; Data; Databases; Detection; Development Plans; Diabetes Mellitus; Diabetic Nephropathy; Dialysis patients; Dialysis procedure; Doctor of Philosophy; Dose; Emergency department visit; End stage renal failure; Exposure to; F2-Isoprostanes; Funding; Future; Glucose; Heat-Shock Proteins 70; Hemodialysis; Home; Hospital Costs; Hospitalization; Hour; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Inflammation Mediators; Inflammatory; Institution; Insulin; Interleukin-6; Intervention; Knowledge; Length of Stay; Longitudinal cohort study; Measures; Mentors; Mentorship; Monitor; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Oxidative Stress; Patients; Pattern; Pharmaceutical Preparations; Phase; Plasma; Population; Prevalence; Renal clearance function; Reporting; Research; Research Methodology; Resources; Risk; Role; Seizures; Stroke; Sulfonylurea Compounds; System; Technology; Testing; Therapeutic; Time; Training; United States National Institutes of Health; Universities; Validation; Venous; base; blood glucose regulation; career; career development; cohort; diabetes management; experience; glucose metabolism; glucose monitor; glycemic control; high risk; improved; innovation; insight; insulin sensitivity; monitoring device; mortality; multidisciplinary; novel; nutrition; patient oriented; point of care; prevent; public health relevance; randomized trial; standard of care; sudden cardiac death; translational study; treatment as usual; trend

Project Summary/Abstract Diabetes affects up to 40% of patients with end-stage renal disease (ESRD). Diabetes management in the context of existing ESRD is challenging due to alterations on glucose metabolism, insulin sensitivity, and also renal clearance of several medications. Thus, most patients with diabetes on dialysis are treated with insulin therapy, resulting in increased risk for hospitalizations for hypoglycemia, mortality, length-of-stay and hospitalization costs at a national level. In many instances, clinicians and patients need to make treatment decisions based on few point-of-care blood glucoses (POC BG) per day, which fails to detect asymptomatic and nocturnal hypoglycemia and are not a good indicator of the 24-hours glycemic excursions. Novel factory-calibrated continuous glucose monitoring (CGM) devices have shown improved accuracy and could fill the critical need for better glycemic monitoring systems in dialysis patients. In this proposal, the PI, Dr. Galindo, will use CGM (Aim 1a) to examine the prevalence of hypoglycemia, hyperglycemia and estimate glycemic variability patterns among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis, (Aim 1b) to assess the accuracy of the CGM in this specific cohort, (Aim 2a) to assess the efficacy of real-time CGM data in preventing hypoglycemia and hyperglycemia, and (Aim 2b) to examine the relationship between glycemic variability and inflammatory/oxidative stress markers in patients participating in Aim 2a. We anticipate that this study will provide novel insights into the glycemic exposure patterns among dialysis patients and will provide preliminary data for future outcomes-based studies determining the best glycemic targets for this group. Dr. Galindo has created a multidisciplinary mentorship team with track record of NIH funding, led by Dr. Umpierrez, with expertise in glucose monitoring and research methodology, and Dr. Tuttle, who is an expert on clinical and translational studies in diabetic kidney disease. His scientific advisory committee includes experts in biostatistics and bioinformatics (Dr. Limin Peng, PhD), and in CGM technology for (Dr. Beck). Dr. Galindo will test the proposed aims within the vast resources available at Emory University - a world-known research institution. The career development plan includes didactic classes, mentored-based training on clinical research and hands-on experience on CGM use and large database analyses. This innovative proposal and formal training plan, will provide Dr. Galindo with the bases for future R01 applications, and an independent career in patient-oriented clinical research.

项目摘要/摘要 糖尿病影响高达40%的终末期肾病(ESRD)患者。糖尿病 由于血糖的变化，在现有ESRD的背景下进行管理是具有挑战性的 代谢、胰岛素敏感性，以及几种药物的肾脏清除。因此，大多数 糖尿病透析患者接受胰岛素治疗，会增加患糖尿病的风险。 因低血糖住院、死亡率、住院时间和住院费用 水平。在许多情况下，临床医生和患者需要根据少数几个因素做出治疗决定 每日护理点血糖(POC BG)，未能检测到无症状和 夜间低血糖并不是24小时血糖漂移的良好指标。 新的工厂校准的连续血糖监测(CGM)设备显示出改进 精确度，可以满足透析中对更好的血糖监测系统的迫切需求 病人。在这项提案中，私人助理加林多博士将使用CGM(目标1a)来检查患病率 糖尿病患者的低血糖、高血糖和血糖变异模式的评估 2型糖尿病(DM2)，接受胰岛素治疗和血液透析(目标1b)，以评估 CGM在这一特定队列中的准确性(目标2a)，以评估实时CGM的有效性 预防低血糖和高血糖的数据，并(目标2b)检查两者之间的关系 参与试验的患者的血糖变异性与炎症/氧化应激标志物之间的关系 在目标2a中。我们预计，这项研究将为血糖暴露提供新的见解。 在透析患者中的模式，并将为未来基于结果的初步数据 为这一群体确定最佳血糖目标的研究。加林多博士创造了一种 有NIH资助记录的多学科指导团队，由Umpierrez博士领导， 在血糖监测和研究方法方面的专业知识，以及塔特尔博士，他是 糖尿病肾病的临床和翻译研究。他的科学顾问委员会 包括生物统计学和生物信息学专家(彭利民博士，博士)和CGM专家 (贝克博士)的技术。加林多博士将在巨大的资源中测试提出的目标 可在埃默里大学--一家世界知名的研究机构--购买。职业发展计划 包括授课、临床研究指导培训和实践 有使用CGM和大型数据库分析的经验。这一创新的建议和正式的 培训计划，将为Galindo博士提供未来R01应用的基础，以及 独立从事以病人为中心的临床研究。