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: 10531573
• 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/10531573
• 关键词: Adrenal Cortex Hormones; Alabama; Algorithms; Award; Behavioral Sciences; Biometry; Caring; Client satisfaction; Clinical; Clinical Management; Clinical Trials; Continuous Glucose Monitor; Data; Development Plans; Diabetes Mellitus; Discipline of obstetrics; Endocrinology; Enrollment; Ensure; Exclusion; 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; Pregnancy Complications; Pregnant Women; Premature Birth; Randomized; Randomized, Controlled Trials; Recommendation; Regimen; Research; Research Design; Research Personnel; 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; comparison control; 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; randomized, clinical trials; respiratory; side effect; skill acquisition; 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 在了解产前皮质类固醇对母体和新生儿的影响方面存在根本性的差距 (ACS)在患有2型糖尿病（T2 DM）的先兆早产（PTB）的女性中施用。 自1972年首次发现ACS对新生儿有益以来，已有40多项随机对照试验 评估其功效。然而，这些试验均未纳入T2 DM女性患者。而 ACS已被证明可降低非糖尿病妇女与PTB相关的新生儿发病率， ACS的影响（母体高血糖和胎儿高胰岛素血症）可能会降低ACS对新生儿的益处 女性T2 DM患者。在我们能够评估ACS在这一人群中的新生儿获益之前， 第一步是优化ACS后母体血糖控制。既往评价母体高血糖症的研究 由于样本量小、回顾性研究设计或血糖数据不足，使用 在随机临床试验中进行动态血糖监测（CGM）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患有艾滋病的妇女的孕产妇和儿童健康。 T2 DM作为独立资助的临床研究者。本提案的研究目标是测试 三种治疗策略在ACS后实现母亲血糖控制的有效性，并评估 母亲血糖控制与新生儿结局之间的关系。我的核心假设是 持续胰岛素输注治疗将改善母体血糖控制，这是改善妊娠结局的关键。 新生儿结局，但代价是患者满意度较低，卫生资源利用率较高。这 将通过以下具体目标来检验假设：1）检验三种治疗方法的疗效 策略（增加滑动比例胰岛素、家庭胰岛素上调和持续胰岛素输注） 在ACS后实现母体血糖控制和2）量化母体血糖 ACS后的控制和新生儿发病率。K23提案中这些目标的完成将决定 最佳策略，以实现ACS后的母亲血糖控制，并通知一个更大的，多中心试验，以改善 T2 DM和威胁性PTB妇女的新生儿结局。该研究计划将得到加强， 来自多学科专家团队的密集指导，在亚拉巴马大学的正式培训， 伯明翰，并参加首屈一指的国家培训计划。训练计划经过精心设计， 确保Battarbee博士实现其指定的职业发展目标：1）扩展CGM数据技能 重复测量的获取、管理和分析; 2）了解行为科学理论， 发展实施科学的技能，3）发展领导多学科研究团队的技能，以及4） 完善赠款写作技巧，以确保有能力为未来的研究获得资金。完成本提案将 转变对接受ACS的T2 DM孕妇的护理，并使Battarbee博士处于独特的地位， R 01资助的独立性，以更大规模地改善T2 DM女性的新生儿结局。