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.

“恢复对低血糖U01联盟的认识受损的障碍：肯塔基大学” 抽象的 对于胰岛素治疗的1型糖尿病（T1D）的人来说，低血糖是其目标的限制步骤 适当控制其血糖并避免长期糖尿病并发症。不幸的是，重复 低血糖的发作已被证明会引起病理过程，从而导致意识障碍 低血糖（IAH）和受损的反调节性反应低血糖，这增加了患风险 威胁生命的低血糖。该赠款申请（响应RFA-DK-21-020）旨在建立10- 现场临床财团以确定导致IAH恢复异质性的因素 并改善了T1D成年人的反调节反应。提议检验假设 1）混合闭环胰岛素泵的晚期糖尿病护理技术完成 使用连续的葡萄糖监测仪（CGM），再加上2）强化低血糖避免教育，将领导 低血糖的频率/严重程度降低，从而提高了低血糖的意识 并改善反调节响应。 RFA中概述的该提案的具体目的是； 1） 确定糖尿病是否使用最新的管理策略来护理（即混合闭环 系统和低血糖避免教育）优化HBA1C的同时最小化低血糖症可以 恢复患有T1D和IAH个体低血糖的认识，2）确定物理因素 与恢复低血糖意识和反调节性反应有关，包括但无 仅限于年龄，糖尿病的持续时间和血糖指标（例如，范围，降低血糖或花费的时间 其他CGM指标）和3）确定当前自我报告问卷的关联（或开发新的 指标）用于使用“最先进的状态”代谢评估来测量CRR的IAH，即 降血糖，高胰岛素夹。肯塔基大学为这一价值做出了良好的贡献 财团的努力是因为1）大学拥有必要的机构基础设施来支持 这项研究，2）该提案概述了几种测量和分析低血糖症的新方法 意识，3）PI组装了一个经验丰富的领导团队，具有T1D的必要专业知识 受试者招募和进行低血糖意识研究，重要的是，4）本网站将提供 NIDDK访问了具有T1D的独特池，经常被理解为粗略的研究主题。