Close the GAP: Glycemic control after Antenatal corticosteroids in women with Pregestational diabetes

缩小差距：妊娠前糖尿病妇女使用产前皮质类固醇后的血糖控制

• 批准号: 10308090
• 负责人: Ashley Nicole Battarbee
• 金额: $ 16.52万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10308090
• 关键词: Adrenal Cortex Hormones; Alabama; Algorithms; Award; Behavioral Sciences; Biometry; Caring; Client satisfaction; Clinical; Clinical Management; Clinical Trials; Data; Development Plans; Diabetes Mellitus; Discipline of obstetrics; Endocrinology; Enrollment; Ensure; Funding; Glucose; Goals; Grant; Health Resources; Home; Hyperglycemia; Hyperinsulinism; Infusion procedures; Insulin; Interdisciplinary Study; Intervention; Knowledge; Lung; Maternal and Child Health; Measures; Mentors; Metabolic dysfunction; Multi-Institutional Clinical Trial; Multicenter Trials; Neonatal; Neonatal respiratory morbidity; Neonatology; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Population; Positioning Attribute; Pregnancy; Pregnant Women; Premature Birth; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Regimen; Research; Research Design; Research Personnel; Research Training; Retrospective Studies; Risk; Sample Size; Scientist; Secure; Slide; Specific qualifier value; Standardization; Structure; Testing; Time; Titrations; Training; Training Programs; United States; Universities; Variant; Woman; Writing; antenatal; career development; clinical practice; cost; data acquisition; efficacy testing; evidence base; experience; fetal; glucose monitor; glycemic control; high risk population; implementation science; improved; maternal hyperglycemia; maternal risk; multidisciplinary; neonatal morbidity; neonatal outcome; neonate; non-diabetic; prospective; respiratory; side effect; skills; theories; treatment strategy

ABSTRACT There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have type 2 diabetes mellitus (T2DM). Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials have been performed evaluating its efficacy. However, none of these trials have included women with T2DM. While ACS have been shown to reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS (maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS in women with T2DM. Before we are able to evaluate the neonatal benefit of ACS in this population, the first step is to optimize maternal glycemic control after ACS. Previous studies evaluating maternal hyperglycemia after ACS have been limited by small sample size, retrospective study design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a randomized clinical trial provides a unique opportunity to overcome these challenges. My long-term goal is to improve maternal and child health among women with T2DM as an independently funded clinical researcher. The research objectives of this proposal are to test the efficacy of three treatment strategies at achieving maternal glycemic control after ACS and evaluate the association between maternal glycemic control and neonatal outcomes. My central hypothesis is that treatment with a continuous insulin infusion will improve maternal glycemic control, which is key to improving neonatal outcomes, but at the cost of less patient satisfaction and more health resource utilization. This hypothesis will be tested by pursuing the following specific aims: 1) Test the efficacy of three treatment strategies (addition of sliding scale insulin, up-titration of home insulin, and continuous insulin infusion) at achieving maternal glycemic control after ACS and 2) Quantify the association between maternal glycemic control after ACS and neonatal morbidity. Completion of these aims in this K23 proposal will determine the optimal strategy to achieve maternal glycemic control after ACS and inform a larger, multicenter trial to improve neonatal outcomes among women with T2DM and threatened PTB. The research plan will be augmented by intensive mentoring from a multidisciplinary team of experts, formal training at the University of Alabama at Birmingham, and participation in premier national training programs. The training plan was carefully crafted to ensure Dr. Battarbee achieves her specified career development goals: 1) Expand skills in CGM data acquisition, management and analysis of repeated measures, 2) Understand behavioral science theory and develop skills in implementation science, 3) Develop skills for leading a multidisciplinary research team, and 4) Refine grant writing skills to ensure ability to secure funding for future research. Completion of this proposal will transform care of pregnant women with T2DM receiving ACS and uniquely position Dr. Battarbee to achieve independence with R01 funding to improve neonatal outcomes of women with T2DM on a larger scale.

摘要 在了解孕期皮质类固醇对母婴的影响方面存在着根本性的差距 (ACS)对患有2型糖尿病(T2 DM)的先兆早产(PTB)妇女的管理。 自从1972年首次发现急性冠脉综合征对新生儿有益以来，已有40多项随机对照试验 对其疗效进行了评估。然而，这些试验中没有一项包括患有T2 DM的女性。而当 研究表明，在非糖尿病女性中，ACS可以降低与肺结核相关的新生儿发病率。 ACS(母体高血糖和胎儿高胰岛素血症)的影响可能会降低ACS对新生儿的益处 在患有T2 DM的女性中。在我们能够评估这一人群中急性冠脉综合征对新生儿的益处之前，第一个 步骤是优化急性冠脉综合征后母亲的血糖控制。先前评估母体高血糖的研究 在受制于小样本量、回溯性研究设计或血糖数据不足的情况下。使用 连续血糖监测(CGM)在随机临床试验中的应用提供了一个独特的机会 克服这些挑战。我的长期目标是改善妇女的母婴健康 T2 DM作为独立资助的临床研究人员。这项建议的研究目的是为了测试 3种治疗策略在急性冠脉综合征后实现母体血糖控制的效果及评价 母亲血糖控制与新生儿结局之间的关系。我的中心假设是 持续的胰岛素输注治疗将改善母亲的血糖控制，这是改善的关键 新生儿结局，但代价是患者满意度降低，卫生资源利用率提高。这 假设将通过追求以下具体目标来检验：1)检验三种治疗方法的疗效 策略(添加滑动比例胰岛素、向上滴定家庭胰岛素和持续胰岛素输注) 在急性冠脉综合征后实现母体血糖控制和2)量化母体血糖与 急性冠脉综合征后的控制和新生儿发病率。完成K23提案中的这些目标将决定 在急性冠脉综合征后实现母亲血糖控制的最佳策略，并通知更大规模的多中心试验以改善 T2 DM和先兆肺结核患者的新生儿结局。这项研究计划将增加以下内容 来自多学科专家团队的密集指导，在阿拉巴马大学的正式培训 伯明翰，以及参加主要的国家培训计划。培训计划是精心制定的，目的是 确保Battarbee博士实现她指定的职业发展目标：1)扩展CGM数据方面的技能 重复测量的获取、管理和分析，2)了解行为科学理论和 培养实施科学方面的技能，3)培养领导多学科研究团队的技能，4) 改进拨款撰写技巧，以确保有能力为未来的研究获得资金。完成这项提案将 2型糖尿病孕妇接受急性冠脉综合征的转变护理和独特的Battarbee医生地位实现 独立与R01资助，在更大范围内改善T2 DM妇女的新生儿结局。