The Biostatistics Research Center for the Impaired Awareness of Hypoglycemia Consortium

低血糖意识障碍联盟生物统计学研究中心

• 批准号: 10599379
• 负责人: Vernon M Chinchilli
• 金额: $ 82.93万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-25 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10599379
• 关键词: Accountability; Adherence; Adult; Adverse event; Advocacy; Ancillary Study; Awareness; Biological Assay; Biological Markers; Biometry; Blood Glucose; Caregivers; Cessation of life; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collection; Coma; Communication; Conduct Clinical Trials; Conflict of Interest; Data; Data Analyses; Data Coordinating Center; Data Management Resources; Development; Devices; Diabetes Mellitus; Digestive System Disorders; Enrollment; Ensure; Evaluation; Family member; Funding; Glucose; Glycosylated hemoglobin A; Health Sciences; Healthcare Systems; Heterogeneity; Hypoglycemia; Impairment; Individual; Institutes; Institutional Review Boards; Insulin-Dependent Diabetes Mellitus; Internet; Investigation; Investigational New Drug Application; Kidney Diseases; Laboratories; Lead; Logistics; Manuals; Manuscripts; Measures; Medical; Medicine; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Patient Self-Report; Patients; Pennsylvania; Preparation; Procedures; Process; Protocols documentation; Psychometrics; Public Health; Publications; Quality Control; Questionnaires; Reporting; Request for Applications; Research; Research Design; Safety; Safety Management; Sample Size; Security; Site Visit; Statistical Data Interpretation; Support System; System; Technology; Time; United States Food and Drug Administration; United States National Institutes of Health; Universities; Validation; Vendor; Visit; acute pancreatitis; base; clinical center; college; cost; data exchange; data management; data submission; design; drug distribution; experience; glucose monitor; improved; member; participant enrollment; programs; quality assurance; randomized trial; recruit; repository; response; restoration; web site

ABSTRACT Individuals with Type 1 Diabetes (T1D) are susceptible to repeated episodes of hypoglycemia, which can result in impaired awareness of hypoglycemia (IAH). As a consequence, IAH contributes to diminished recognition of the need for external glucose and the blunting of counter-regulatory responses that are required to increase blood glucose. This can be a very risky situation for T1D individuals with IAH, possibly leading to coma and in some circumstances, death. This can be a very risky situation for T1D individuals with IAH, possibly leading to coma and in some circumstances, death. Many T1D studies exclude IAH individuals because of confounding issues. Therefore, the National Institute for Diabetes and Digestive and Kidney Diseases (NIDKK) has issued two RFAs to form the IAH Consortium that will investigate factors which contribute to the heterogeneity of restoration of awareness of hypoglycemia in adult T1D individuals with IAH. RFA-DK-21-020 and RFA-DK-21- 036 request applications for Clinical Centers and the sole Biostatistics Research Center (BRC), respectively. The objectives of the IAH Consortium will be to • determine if the most up-to-date management strategies using diabetes technology to optimize HbA1c while minimizing hypoglycemia can restore awareness of hypoglycemia and improve counter-regulatory responses in individuals with T1D and IAH • identify the magnitude and duration of time in range, time spent in hypoglycemia or other metrics for continuous glucose monitors that are associated with restoration of awareness of hypoglycemia • determine the association of current or newly developed self-reported measures of IAH with counter- regulatory responses to elucidate the heterogeneity in restoration of hypoglycemia awareness The Department of Public Health Sciences at The Pennsylvania State University College of Medicine proposes to serve as the BRC for the IAH Consortium, and will pursue seven specific aims. Specific Aim 1: Collaborate on the development and conduct of studies, and lead statistical analyses Specific Aim 2: Lead the Consortium in developing measures of self-reported IAH Specific Aim 3: House a Central Laboratory Specific Aim 4: Lead the Consortium in stakeholder engagement Specific Aim 5: Develop data management and website processes Specific Aim 6: Maintain regulatory compliance Specific Aim 7: Provide communication and project management support

抽象的 1 型糖尿病 (T1D) 患者容易反复发生低血糖，这可能导致 低血糖意识受损 (IAH) 因此，IAH 会导致对低血糖的认知能力下降。 对外部葡萄糖的需求以及增加所需的反调节反应的减弱 对于患有 IAH 的 T1D 患者来说，这可能是一种非常危险的情况，可能会导致昏迷和昏迷。 在某些情况下，这对于患有 IAH 的 T1D 患者来说可能是一种非常危险的情况，可能会导致死亡。 由于混杂因素，许多 T1D 研究排除了 IAH 个体。 因此，国家糖尿病、消化和肾脏疾病研究所 (NIDKK) 发布了这一问题。 两个 RFA 组成 IAH 联盟，该联盟将研究导致异质性的因素 恢复患有 RFA-DK-21-020 和 RFA-DK-21- 的成人 T1D 患者的低血糖意识。 036 分别请求临床中心和唯一的生物统计研究中心（BRC）的申请。 IAH 联盟的目标是 • 确定是否使用糖尿病技术来优化 HbA1c 的最新管理策略 同时最大限度地减少低血糖可以恢复低血糖意识并改善反调节 T1D 和 IAH 患者的反应 • 确定范围内的时间强度和持续时间、发生低血糖的时间或其他指标 与低血糖意识恢复相关的连续血糖监测仪 • 确定当前或新制定的IAH 自我报告措施与反措施之间的关联 阐明低血糖意识恢复中的异质性的监管反应 宾夕法尼亚州立大学医学院公共卫生科学系的提案 担任 IAH 联盟的 BRC，并将实现七个具体目标。 具体目标 1：合作开展和开展研究，并领导统计分析 具体目标 2：领导联盟制定自我报告 IAH 的措施 具体目标 3：建立一个中心实验室 具体目标 4：领导联盟参与利益相关者参与 具体目标 5：开发数据管理和网站流程 具体目标 6：保持监管合规性 具体目标 7：提供沟通和项目管理支持