Hypoglycemia and glycemic control in patients treated with dialysis

透析患者的低血糖和血糖控制

• 批准号: 10408827
• 负责人: Ian H de Boer
• 金额: $ 64.42万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-21 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10408827
• 关键词: Accidents; Acute; Area; Arrhythmia; Biological Markers; Blood Glucose; Cardiovascular system; Caring; Chronic Care; Clinical; Clinical Data; Clinical Management; Clinical Practice Guideline; Clinical Trials; Cohort Studies; Coma; Communities; Conflict (Psychology); Data; Diabetes Mellitus; Diabetic Ketoacidosis; Diagnosis; Diagnostic; Dialysis patients; Dialysis procedure; Dimensions; Emergency Situation; End stage renal failure; Enrollment; Erythrocytes; Event; Foundations; Fracture; Frequencies; Fright; Gluconeogenesis; Glucose; Glycosylated hemoglobin A; Goals; Hemodialysis; Hospitalization; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Incidence; Infection; Insulin; Intervention Studies; Kidney; Lead; Longevity; Longitudinal Studies; Maintenance; Measurement; Measures; Medical; Methods; Modernization; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Pain; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Perception; Peripheral Nervous System Diseases; Peritoneal Dialysis; Pharmaceutical Preparations; Population; Population Intervention; Procedures; Proteins; Protocols documentation; Provider; Quality of life; Renal function; Research; Research Project Grants; Residual state; Retinal Diseases; Risk; Risk Factors; Severities; Signs and Symptoms; Sulfonylurea Compounds; Symptoms; Technology; Technology Assessment; Testing; Therapeutic; Time; Vision; Visit; Work; acute care; autonomic neuropathy; base; clinical care; clinical risk; clinically relevant; cohort; diabetes distress; experience; falls; glucose monitor; glycemic control; improved; improved outcome; insight; metropolitan; mortality; multidisciplinary; novel strategies; patient oriented; patient population; patient subsets; prospective; response; satisfaction; standard measure; tool; wasting

PROJECT SUMMARY/ABSTRACT Hypoglycemia and hyperglycemia are common and morbid problems for end stage kidney disease patients treated with dialysis. Severe hypoglycemia occurs frequently among dialysis patients with and without diabetes due to reduced kidney gluconeogenesis, protein-energy wasting, a blunted counter-regulatory response, and reduced medication clearance and may cause substantial morbidity due to accidents, arrhythmias, and cardiovascular events. However, accurate rates of hypoglycemia (including subclinical episodes), hypoglycemia risk factors, and associations of hypoglycemia with clinical outcomes are not known in the dialysis population. Conversely, hyperglycemia due to inadequately treated diabetes may promote painful peripheral neuropathy, vision-threatening retinopathy, and infections, but standard measures of glycemia such as hemoglobin A1c are known to be unreliable among dialysis patients, leading to diagnostic and therapeutic nihilism. The goal of this research project is to comprehensively define glycemia in dialysis patients using modern continuous glucose monitoring (CGM) technology, informing needs for clinical care and building a foundation for intervention studies. CGM offers a new paradigm for glycemia assessment and management that can provide new scientific insights and potentially change the clinical approach to glycemic management. However, there has been no large, externally valid study to understand the incidence or severity of abnormalities detectable by CGM, identify which patients may benefit most from use of CGM, or examine whether CGM metrics are related to clinically relevant outcomes in this population. We propose a prospective community-based cohort study of 800 patients treated with dialysis at Northwest Kidney Centers, a not-for- profit organization that provides the majority of dialysis care in the greater Seattle metropolitan area. The foundation of the cohort study will be a 10-day period of CGM, performed at baseline using cutting-edge technology. A participatory approach to research will enhance enrollment, external validity, and clinical relevance. With this cohort, we aim to (1) determine the incidence and severity of hypoglycemia and its clinical risk factors among dialysis patients with and without diabetes; (2) define the distribution and clinical correlates of glucose time in range and related CGM metrics among dialysis patients with diabetes; and (3) test associations of hypoglycemia and time in range with clinical outcomes relevant to dialysis patients. Results may suggest opportunities for CGM implementation to improve clinical care and will define appropriate populations, interventions, outcomes, and power assumptions for clinical trials.

项目总结/摘要 低血糖和高血糖是终末期肾病患者常见的病理问题 接受透析治疗严重的低血糖在有糖尿病和无糖尿病的透析患者中经常发生 由于肾脏新生血管减少、蛋白质能量消耗、反调节反应减弱， 药物清除率降低，并可能因事故、心律失常和 心血管事件。然而，低血糖（包括亚临床发作）的准确发生率， 低血糖风险因素，以及低血糖与临床结局的相关性尚不清楚。 透析人群。相反，由于糖尿病治疗不当而导致的高血糖可能会促进疼痛， 周围神经病变，威胁视力的视网膜病变和感染，但标准措施， 由于血红蛋白A1 c在透析患者中是不可靠的，导致诊断和治疗 虚无主义本研究项目的目标是使用以下方法全面定义透析患者的透析 现代动态葡萄糖监测（CGM）技术，告知临床护理需求，并建立一个 干预研究基金会。CGM提供了一个新的范例，为可持续发展评估和管理 这可以提供新的科学见解，并可能改变血糖管理的临床方法。 然而，还没有大型的外部有效研究来了解 CGM可检测到的异常，确定哪些患者可能从CGM的使用中获益最多，或检查 CGM指标是否与该人群的临床相关结局相关。我们提出了一个前瞻性的 一项基于社区的队列研究，对800名在西北肾脏中心接受透析治疗的患者进行了研究， 在大西雅图都市区提供大部分透析护理的盈利组织。的 队列研究的基础将是10天的CGM，在基线时使用最先进的 技术.参与式研究方法将提高入学率，外部效度和临床 本案无关通过该队列，我们的目的是（1）确定低血糖的发生率和严重程度及其临床意义， 糖尿病与非糖尿病透析患者的危险因素;（2）确定分布和临床相关因素 糖尿病透析患者的血糖时间范围和相关CGM指标;（3）测试 低血糖和范围内时间与透析患者相关临床结局的相关性。结果 可能建议CGM实施的机会，以改善临床护理，并将定义适当的 临床试验的人群、干预措施、结局和功效假设。