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.