Continuous glucose monitoring for management of type 2 diabetes in pregnancy (CGM2 trial)

There is a fundamental knowledge gap in achieving maternal glycemic control sufficient to reduce maternal and neonatal morbidity and mortality in pregnant individuals with type 2 diabetes mellitus (T2DM). Nearly all pregnant individuals with T2DM experience either maternal or newborn morbidity, with disparities seen in

socially disadvantaged groups. The key to reducing these adverse outcomes, especially for the newborn, is achieving maternal glycemic control; and the first step towards this goal is effective glucose monitoring. Current self-monitoring of blood glucose (SMBG) 4 times daily is burdensome and only provides snapshots of

glycemic status. Compared to SMBG, continuous glucose monitoring (CGM) was shown to improve maternal glycemic control and reduce the risk of adverse neonatal outcomes in type 1 diabetes (T1DM) pregnancies, but the benefits in T2DM pregnancies are unknown. An additional challenge is that what constitutes adequate

glycemic control in T2DM pregnancies is also unknown. While there are established glucose targets for SMBG and CGM, the percentage of glucose values that should meet these targets is not clear. Last, social determinants of health must also be addressed as they create barriers to T2DM management and contribute to

up to 60% of disparities in outcomes. The overarching goal is to improve short- and long-term maternal and child outcomes and achieve health equity among pregnant individuals with T2DM. The research objective of this proposal is to determine the effectiveness of real-time CGM at reducing maternal and neonatal morbidity,

define an outcome-based definition for glycemic control and identify social and structural barriers to improving outcomes. The central hypothesis is that real-time CGM provides patients and providers the necessary tool to prevent maternal hyperglycemia and improve neonatal outcomes in T2DM pregnancies. Additionally, we

hypothesize that unfavorable social determinants of health interfere with T2DM management and result in disparate outcomes. These hypotheses will be tested by pursuing the following specific aims: 1) Determine the effectiveness of real-time CGM at reducing neonatal morbidity and mortality in pregnant individuals with

T2DM, compared to SMBG, 2) Determine the effectiveness of real-time CGM at improving maternal glycemic control and reducing maternal morbidity, compared to SMBG, and 3) Identify the biologic, personal, social and ecological factors associated with morbidity and mortality of neonates born to pregnant individuals with T2DM.

Successful completion of the proposed study will determine if real-time CGM, compared to SMBG, improves maternal and neonatal outcomes in pregnant individuals with T2DM and define what SMBG and CGM goals constitute adequate glycemic control. Identification of the social determinants of health associated with

disparities in this historically disadvantaged population will lay the foundation for future intervention studies to improve health equity. This project has the potential to revolutionize management of T2DM in pregnancy and impact the lives of 100,000 pregnant individuals and their children in the U.S. each year.