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.

“恢复受损的低血糖意识U01联盟：肯塔基大学” 摘要 对于接受胰岛素治疗的1型糖尿病患者(T1D)来说，低血糖是他们达到以下目标的限速步骤 适当控制血糖，避免糖尿病长期并发症。不幸的是，反复 已有研究表明，一连串的低血糖会导致意识受损的病理过程。 低血糖(IAH)和受损的反调节反应低血糖增加了 危及生命的低血糖。本赠款申请(响应RFA-DK-21-020)寻求建立一个10- 现场临床联盟确定导致IAH修复异质性的因素 并改善了患有T1D的成年个体的反调节反应。有人建议对这一假设进行检验 这是先进的糖尿病护理技术的组合，包括混合闭环式胰岛素泵 通过持续血糖监测(CGM)，再加上强化的低血糖避免教育，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 完善反监管应对措施。如《框架协议》所述，这项建议的具体目标是：1) 确定是否使用最新的管理策略(即混合闭环)进行糖尿病护理 系统和低血糖避免教育)，其优化HbA1c，同时最小化低血糖 在患有T1D和IAH的个体中恢复低血糖意识，2)决定 与低血糖意识的恢复和反调节反应有关，包括但不是 限于年龄、糖尿病病程和血糖指标(例如，在范围内的时间、低血糖所花费的时间或 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)，通过使用“最先进”的代谢评估测量CRR来识别IAH，即 降血糖、高胰岛素钳夹。肯塔基大学已经做好准备，为这一宝贵的 财团的努力，因为1)大学拥有必要的机构基础设施，以支持以下各方面 这项研究，2)这项建议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，具有T1D所需的专业知识 招募受试者和进行低血糖意识研究，重要的是，该网站将提供 NIDDK可以获得独特的美国农村研究对象池，这些研究对象通常是未被充分研究的，患有T1D。