The Biostatistics Research Center for the Impaired Awareness of Hypoglycemia Consortium

摘要 1型糖尿病(T1D)患者容易反复发生低血糖，这可能会导致 低血糖(IAH)意识受损。因此，IAH有助于减少对 对外部葡萄糖的需求和需要增加的反调节反应的钝化 血糖。对于患有IAH的T1D患者来说，这是一个非常危险的情况，可能会导致昏迷和 在某些情况下，死亡。对于患有IAH的T1D患者来说，这可能是一个非常危险的情况，可能导致 昏迷，在某些情况下，死亡。由于混淆，许多T1D研究排除了IAH患者 问题。因此，国家糖尿病、消化和肾脏疾病研究所(NIDKK)发布了 两个RFA将组成IAH联盟，该联盟将调查导致 患有IAH的成人T1D患者低血糖意识的恢复。RFA-DK-21-020和RFA-DK-21- 036分别申请临床中心和唯一的生物统计学研究中心(BRC)。 IAH联盟的目标将是 ·确定使用糖尿病技术优化HbA1c的最新管理策略 同时最大限度地减少低血糖可以恢复对低血糖的认识并改善反调节 T1D和IAH患者的反应 ·确定范围内的时间大小和持续时间、低血糖所用时间或其他指标 与低血糖意识恢复相关的连续血糖监测仪 ·确定现行或新制定的IAH自我报告措施与反-- 阐明低血糖意识恢复过程中异质性的调节反应 宾夕法尼亚州立大学医学院公共卫生科学系建议 作为IAH联盟的BRC，并将追求七个具体目标。 具体目标1：协作制定和进行研究，并领导统计分析 具体目标2：领导该联合会制定自我报告的IAH措施 具体目标3：建立一个中心实验室 具体目标4：在利益相关者参与方面领导财团 具体目标5：制定数据管理和网站流程 具体目标6：保持法规遵从性 具体目标7：提供沟通和项目管理支助

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