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.
The proposed study seeks to advance management of women with type 2 diabetes mellitus receiving antenatal corticosteroids by testing the efficacy of three treatment strategies at achieving maternal glycemic control and subsequently evaluating the association between maternal glycemic control and neonatal outcomes. This will enhance the candidate?s career development to independent research in type 2 diabetes mellitus and pregnancy.