Restoration of Impaired Awareness of Hypoglycemia U01 Consortium: University of Kentucky

低血糖意识受损的恢复 U01 联盟：肯塔基大学

• 批准号: 10597307
• 负责人: SIMON J FISHER
• 金额: $ 37.44万
• 依托单位: UNIVERSITY OF KENTUCKY
• 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/10597307
• 关键词: Adult; Age; Applications Grants; Awareness; Blood Glucose; Caring; Clinical Research; Closure by clamp; Complications of Diabetes Mellitus; Coupled; Development; Diabetes Mellitus; Education; Event; Failure; Frequencies; Glucose; Glycosylated hemoglobin A; Goals; Heterogeneity; Hormones; Hybrids; Hypoglycemia; Impairment; Individual; Infrastructure; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Intervention; Kentucky; Leadership; Life; Measurement; Measures; Metabolic; Methodology; National Institute of Diabetes and Digestive and Kidney Diseases; Pathologic Processes; Patient Self-Report; Patients; Persons; Physiological; Play; Questionnaires; Recurrence; Research; Research Project Grants; Risk; Role; Rural; Severities; Site; Study Subject; Symptoms; System; Technology; Testing; Time; U-Series Cooperative Agreements; Universities; base; burden of illness; clinical research site; counterregulation; experience; follow-up; glucose monitor; improved; novel; novel strategies; recruit; response; restoration

“Restoration of Impaired Awareness of Hypoglycemia U01 Consortium: University of Kentucky” Abstract For insulin-treated people with Type 1 Diabetes (T1D), hypoglycemia is the rate limiting step in their goals to appropriately control their blood sugar and avoid long-term diabetes complications. Unfortunately, repeated episodes of hypoglycemia have been shown to induce a pathological process leading to impaired awareness of hypoglycemia (IAH) and an impaired counterregulatory response hypoglycemia that increases the risk for life-threatening hypoglycemia. This grant application (in response to RFA-DK-21-020) seeks to establish a 10- site clinical consortium to determine the factors that contribute to the heterogeneity in the restoration of IAH and improved counterregulatory responses in adult individuals with T1D. It is proposed to test the hypothesis that a combination of, 1) advanced diabetes care technology comprised of a hybrid closed loop insulin pump with continuous glucose monitor (CGM), coupled with 2) intensive hypoglycemia avoidance education, will lead to a decrease in the frequency/severity of hypoglycemia and thereby improve the awareness of hypoglycemia and improve the counterregulatory response. The specific aims of this proposal, as outlined in the RFA, are; 1) determine if diabetes care with use of the most up-to-date management strategies (i.e. a hybrid closed loop system and hypoglycemia avoidance education) which optimizes HbA1c while minimizing hypoglycemia can restore awareness of hypoglycemia in individuals with T1D and IAH, 2) determine the physiological factors that are associated with restoration of hypoglycemia awareness and counterregulatory response, including but not limited to age, duration of diabetes and metrics of glycemia (eg, time in range, time spent in hypoglycemia or other CGM metrics), and 3) determine the association of the current self-report questionnaires (or develop new metrics) for identification of IAH with measurement of CRR using "state of the art" metabolic assessments, i.e. hypoglycemic, hyperinsulinemic clamps. The University of Kentucky is well-poised to contribute to this valuable consortium effort because 1) the University has the requisite institutional infrastructure to support all aspects of this research, 2) this proposal outlines several novel approaches to measure and analyze hypoglycemia awareness, 3) the PI has assembled an experienced leadership team has the requisite expertise in T1D subject recruitment and conducting hypoglycemia awareness studies, and importantly, 4) this site will provide the NIDDK with access to unique pool of US-based, often understudied, rural study subjects with T1D.

“恢复低血糖意识受损 U01 联盟：肯塔基大学” 抽象的 对于接受胰岛素治疗的 1 型糖尿病 (T1D) 患者来说，低血糖是他们实现目标的速率限制步骤 适当控制血糖，避免糖尿病并发症的长期不幸反复。 低血糖发作已被证明会诱发导致意识受损的病理过程 低血糖（IAH）和反调节反应受损低血糖会增加以下风险： 该拨款申请（响应 RFA-DK-21-020）旨在建立 10- 现场临床联盟以确定导致 IAH 恢复异质性的因素 并改善了患有 T1D 的成年个体的反调节反应。建议检验该假设。 1) 先进的糖尿病护理技术的组合，由混合闭环胰岛素泵组成 连续血糖监测仪 (CGM) 结合 2) 低强度血糖避免教育，将导致 降低低血糖的频率/严重程度，从而提高对低血糖的认识 正如 RFA 中概述的，该提案的具体目标是：1) 确定是否使用最新的管理策略（即混合闭环 系统和低血糖避免教育），优化 HbA1c，同时最大限度地减少低血糖，可以 恢复 T1D 和 IAH 患者对低血糖的认识，2) 确定导致低血糖的生理因素 与低血糖意识的恢复和反调节反应相关，包括但不 仅限于年龄、糖尿病病程和血糖指标（例如，范围内的时间、发生低血糖的时间或 其他 CGM 指标），以及 3）确定当前自我报告问卷的关联（或开发新的 指标）用于通过使用“最先进的”代谢评估测量 CRR 来识别 IAH，即 肯塔基大学已准备好为这一宝贵的成果做出贡献。 联盟的努力，因为 1) 大学拥有必要的机构基础设施来支持各个方面 这项研究，2) 该提案概述了几种测量和分析低血糖的新方法 意识，3) PI 组建了一支经验丰富的领导团队，拥有 T1D 所需的专业知识 受试者招募和进行低血糖意识研究，重要的是，4）该网站将提供 NIDDK 拥有独特的美国农村 T1D 研究对象库，这些对象通常未被充分研究。