DETERMINING HIGH-YIELD RISK FACTORS FOR DIABETES IN EMERGENCY DEPT PATIENTS

确定急诊科患者糖尿病的高风险因素

• 批准号: 7606184
• 负责人: Michelle Charfen
• 金额: $ 2.52万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606184
• 关键词: Accident and Emergency department; Acute; Back; Blood; Blood Glucose; Blood specimen; Body mass index; Caring; Characteristics; Chemistry; Chronic; Clinical; Computer Retrieval of Information on Scientific Projects Database; Data; Data Collection; Databases; Diabetes Mellitus; Diagnosis; Disease; Emergency Situation; Eye; Family history of; Fasting; Funding; Glucose; Grant; Healthcare; Heart; Hemoglobin; Hospitals; Human Resources; Hydrocortisone; Informed Consent; Institution; Kidney; Laboratories; Location; Medical; Medical Records; Minority; Monitor; Numbers; OGTT; Observational Study; Operative Surgical Procedures; Organ; Outpatients; Patients; Persons; Plasma; Primary Health Care; Procedures; Protocols documentation; Provider; Purpose; Reporting; Research; Research Personnel; Resources; Risk; Risk Factors; Safety; Screening procedure; Solutions; Source; Systemic disease; Testing; Time; Underserved Population; United States National Institutes of Health; Visit; Week; Work; Writing; base; care seeking; day; drinking; follow-up; health care service utilization; prevent; prospective

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Diabetes is a chronic systemic disease which, over time, causes a severe and irreversible damage to the kidneys, heart, eyes, and other organs. The progression of such damage can be delayed or prevented through treatment to control blood sugar levels. Unfortunately, as many as half of all persons with diabetes do not know they have the disease and thus receive no treatment. Such patients are disproportionately found within minority and underserved populations, such as those that frequently seek care in hospital emergency departments. The purpose of this study is to identify patient and clinical characteristics which can be used to identify the at-risk patients most likely to benefit from formal screening for diabetes. This study is a prospective, observational study. Eligible patients will be identified by their clinical care providers in the emergency department, based on recognized risk factors for the subsequent identification of diabetes (e.g., body mass index [BMI], elevated blood glucose noted in the emergency department, family history). Clinical care providers will ask patients if they would be willing to speak with study personnel. Willing patients will then be approached by study personnel and written informed consent for participation will be sought. Those who agree to participate will then have additional laboratory tests obtained (chemistries, hemoglobin A1C, cortisol level) and additional clinical and demographic data will be obtained. Patients to be admitted to the hospital for serious medical and surgical illness, as defined in the protocol, will be excluded. After a period of 6 weeks, during which time patients will be expected to have recovered from their acute illness, patients will be brought back to the outpatient facility of the GCRC for follow-up testing. Follow-up testing will include additional blood work and either a formal fasting plasma glucose (FPG) or oral glucose tolerance test (OGTT). The oral glucose tolerance test consists of having the subject drink a sugary solution, followed by several blood samples to determine whether they have diabetes. Patients with positive results will be asked to return for a second visit during which they will undergo repeat testing. The ADA states that a diagnosis of diabetes needs to be confirmed on a separate day. Patients found to have diabetes on formal testing will be referred to appropriate primary care providers for management of their disease. In addition, medical records will be reviewed to obtain additional information of diagnosis and health care utilization for the prior and subsequent 6 months. Written informed consent will be obtained from all subjects prior to the initiation of any study-specific procedures and for the recording of protected healthcare information (PHI). Further, all data will be recorded without identifiers on data collection forms and stored in locked locations. A separate sheet identifying patients by study number will be kept in a different locked location. Information will only be entered into password-protected electronic databases and all information will be reported without patient identifiers. The study will be monitored in accordance with an approved data safety monitoring plan through the GCRC.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 糖尿病是一种慢性全身性疾病，随着时间的流逝，糖尿病会对肾脏，心脏，眼睛和其他器官造成严重且不可逆转的损害。 通过治疗可以延迟或阻止这种损害的进展以控制血糖水平。 不幸的是，多达一半的糖尿病患者不知道他们患有这种疾病，因此没有接受治疗。 此类患者在少数群体和服务不足的人群中，例如经常在医院急诊室寻求护理的患者。 这项研究的目的是鉴定患者和临床特征，可用于识别最有可能受益于糖尿病正式筛查的高危患者。 这项研究是一项前瞻性，观察性研究。 急诊室的临床护理提供者将根据公认的糖尿病识别危险因素（例如体重指数[BMI]，急诊科中升高的血糖升高，家族史，家族史）。 临床护理提供者会询问患者是否愿意与学习人员交谈。然后，将寻求愿意的患者与研究人员联系，并寻求书面知情同意。 那些同意参加的人将获得其他实验室测试（化学，血红蛋白A1C，皮质醇水平），并获得其他临床和人口统计数据。 该方案中定义的严重医学和外科疾病医院的患者将被排除在外。 经过6周的时间，在此期间，预计患者将从急性疾病中康复，将使患者重新回到GCRC的门诊设施进行后续测试。 后续测试将包括其他血液检查，以及正式的禁食血浆葡萄糖（FPG）或口服葡萄糖耐受性测试（OGTT）。口服葡萄糖耐受性测试包括让该受试者饮用含糖溶液，然后是几个血液样本，以确定它们是否患有糖尿病。阳性结果的患者将被要求返回第二次访问，在此期间他们将进行重复测试。 ADA指出，糖尿病的诊断需要在不同的一天得到确认。发现患有正式测试的糖尿病的患者将转交给适当的初级保健提供者以治疗其疾病。 此外，将审查医疗记录，以获取先前及以后6个月的诊断和医疗保健利用的其他信息。 在启动任何特定研究程序和记录受保护的医疗保健信息（PHI）之前，将从所有受试者中获得书面知情同意书。 此外，所有数据都将在数据收集表上没有标识符并存储在锁定位置中的情况下记录。 一张单独的表格识别患者按研究编号保存在不同的锁定位置。 信息仅将输入到受密码保护的电子数据库中，并且所有信息将在没有患者标识符的情况下报告。 该研究将根据批准的数据安全监控计划进行监控。