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 患有1型糖尿病（T1D）的个体容易受到低血糖的重复发作的影响，这可能导致 意识到低血糖（IAH）的意识受损。结果，IAH有助于认识到 需要外部葡萄糖和增加增加的反应反应的钝化 血糖。对于具有IAH的T1D个人而言，这可能是一个非常冒险的情况，可能导致昏迷和 在某些情况下，死亡。对于具有IAH的T1D个人而言，这可能是一个非常冒险的情况，可能导致 昏迷，在某些情况下，死亡。许多T1D研究都排除了IAH个人，因为 问题。因此，美国国家糖尿病和消化和肾脏疾病（NIDKK）已发出 两个RFA组成IAH联盟，该联盟将研究有助于异质性的因素 恢复IAH成年T1D患者低血糖的认识。 RFA-DK-21-020和RFA-DK-21-- 036分别为临床中心和唯一的生物统计研究中心（BRC）申请申请。 IAH财团的对象将是 •确定使用糖尿病技术最新的管理策略来优化HBA1C 在最小化低血糖症的同时，可以恢复对低血糖的认识并改善反调节性 T1D和IAH的个体的响应 •确定范围的幅度和持续时间，在低血糖或其他指标上花费的时间 连续的葡萄糖监测器与恢复低血糖认识有关 •确定IAH的当前或新开发的自我报告的措施与反对的关联 调节性响应以阐明恢复低血糖意识的异质性 宾夕法尼亚州立大学医学院公共卫生科学系提案 作为IAH财团的BRC，并将追求七个特定目标。 特定目的1：协作研究和进行研究和领导统计分析 特定目标2：领导财团制定自我报告的IAH量度 特定目的3：容纳中央实验室 特定目标4：领导联盟在利益相关者参与中 特定目标5：开发数据管理和网站流程 特定目标6：维护法规合规性 特定目标7：提供沟通和项目管理支持