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

> **NIH NIH R01** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2024 · $829,637

## Abstract

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 equ...

## Key facts

- **NIH application ID:** 10776545
- **Project number:** 1R01HD113612-01
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Ashley Nicole Battarbee
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $829,637
- **Award type:** 1
- **Project period:** 2024-09-13 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10776545

## Citation

> US National Institutes of Health, RePORTER application 10776545, Continuous glucose monitoring for management of type 2 diabetes in pregnancy (CGM2 trial) (1R01HD113612-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10776545. Licensed CC0.

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