# Early Detection of Gestational Diabetes Mellitus in Pregnancy

> **NIH NIH K23** · UNIV OF MASSACHUSETTS MED SCH WORCESTER · 2024 · $163,039

## Abstract

Project Summary/Abstract
Gestational diabetes mellitus (GDM) is an important contributor to maternal and neonatal
morbidity and mortality in pregnancy. Approximately 1 in 8 pregnancies is impacted by GDM
worldwide. Despite adverse intergenerational outcomes associated with GDM, this condition is
not detected sufficiently early in regular obstetrics practice. Professional societies recommend
screening for GDM; however, guidance is inconsistent and late in pregnancy, thus precluding
meaningful time to intervene for maternal-offspring benefit. A clinical predictive model that
combines clinical risk factors and simple serum biomarkers has shown clinical promise due to
its excellent discriminatory ability but has lacked clinical implementation. Therefore, the goal of
the proposed research is to: 1) develop an implementation protocol and 2) test the feasibility
and acceptability of a first trimester screening protocol for the early detection of GDM. We will
conduct a pilot randomized controlled trial among 80 high-risk pregnant women in the first
trimester. Participants will be randomized to protocolized early GDM screening with serum
biomarkers before 14 weeks gestation or to standard of care (i.e., early screening with
additional screening between 24 and 28 weeks of gestation). The proposed K23 award will build
on my background in obstetric research focused on diabetes and high-risk pregnancy
management. This award will allow me to achieve my training goals: 1) obtain advanced training
in statical methods and clinical research methods related to clinical trial design, 2) gain
knowledge surrounding mixed methods assessment, 3) develop expertise in executing real-
world trials with implementation science methods to test and sustain interventions in obstetric
populations, and 4) enhance leadership and academic writing skills to become a successful
clinical scientist. Additionally, this award will contribute to my long-term goal of becoming an
independent physician-scientist focused on improving the perinatal care of women and their
children who develop diabetes during pregnancy. My multidisciplinary mentoring team, and the
supportive research environment at the University of Massachusetts Chan Medical School,
provide the necessary support for me to achieve my training and research goals. This award will
set the stage for a future R01 application to conduct a large scale, multi-site randomized
controlled trial assessing the widespread implementation and effectiveness of our early diabetes
screening protocol compared with current care standards.

## Key facts

- **NIH application ID:** 10808401
- **Project number:** 1K23HD111526-01A1
- **Recipient organization:** UNIV OF MASSACHUSETTS MED SCH WORCESTER
- **Principal Investigator:** Gianna Lusiye Wilkie
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $163,039
- **Award type:** 1
- **Project period:** 2024-07-10 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10808401

## Citation

> US National Institutes of Health, RePORTER application 10808401, Early Detection of Gestational Diabetes Mellitus in Pregnancy (1K23HD111526-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10808401. Licensed CC0.

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