# Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial

> **NIH NIH R01** · INDIANA UNIVERSITY INDIANAPOLIS · 2022 · $641,203

## Abstract

PROJECT SUMMARY
The prevalence of both obesity and gestational diabetes mellitus (GDM) have increased, and each is associated
with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of
pregnancy, and cesarean delivery. Women with GDM who are also overweight and obese have higher rates of
pregnancy complications when compared to normal weight women with GDM, which may occur in part due to
suboptimal glycemic control. The current recommendations for glycemic targets in pregnant women with
diabetes are not rigorously defined, and they far exceed the mean fasting (70.9 ±7.8 mg/dL) and 1 hour post-
prandial (108.9 ± 12.9 mg/dL) glucose values in pregnant women without GDM. Our prior work demonstrated
that use of intensive (fasting <90, 1 hr post-prandial <120 mg/dL) compared to standard (fasting <95 mg/dL, 1
hr post-prandial <140 mg/dL) glycemic targets resulted in improved glycemic control without increasing the risk
for hypoglycemia. The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes
Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomized clinical trial designed to
investigate the impact of intensive versus standard glycemic targets on perinatal outcomes in women with GDM
who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from 4
medical centers representing regions of the U.S. with high rates of obesity will randomize 828 overweight and
obese women with GDM to either intensive or standard glycemic targets.
The specific aims of this project are: 1) Determine the effectiveness of intensive glycemic targets in reducing the
risk for neonatal composite morbidity and large for gestational age birthweight in overweight and obese women
with GDM, 2) Assess the safety of intensive glycemic targets as measured by the frequency of maternal
hypoglycemia in overweight and obese women with GDM, and 3) Evaluate the cost-effectiveness of intensive
glycemic control compared with standard glycemic control as measured by the incremental cost per case of
neonatal morbidity and LGA birth weight prevented and per Quality-adjusted Life-year. The expected outcome
of this study is high-quality evidence on the effectiveness, safety, and cost-effectiveness of intensive glycemic
targets in reducing adverse perinatal outcomes among overweight and obese women with GDM. If proven
effective, use of intensive glycemic targets in overweight and obese women with GDM will have an important
positive impact on the health of these high risk women and their infants.

## Key facts

- **NIH application ID:** 10399482
- **Project number:** 5R01HD101476-02
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Christina Marie Scifres
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $641,203
- **Award type:** 5
- **Project period:** 2021-05-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10399482

## Citation

> US National Institutes of Health, RePORTER application 10399482, Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (5R01HD101476-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10399482. Licensed CC0.

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