COLUMBUS, Ohio – Gestational diabetes is on the rise among pregnant people, and now a research team at The Ohio State University Wexner Medical Center has received a $12 million funding award from the Patient-Centered Outcomes Research Institute (PCORI) to define the best treatment when medication becomes necessary. The study, led by Maternal Fetal Medicine in the Department of Obstetrics and Gynecology, will compare oral metformin versus injectable insulin. Gestational diabetes impacts nearly 75,000 pregnant individuals and their unborn babies each year in the United States, and according to the Centers for Disease Control cases have risen 30% since 2016.
“Patients and providers face the decision of how best to treat gestational diabetes every day and need high-quality and contemporary evidence to inform their choice,” said the study’s co-principal investigator Kartik Venkatesh, MD, PhD, a maternal fetal medicine physician, epidemiologist and director of the Diabetes in Pregnancy Program.
“Gestational diabetes is a significant public health concern and our study will greatly benefit our patients in a meaningful way,” said Mark Landon, MD, co-principal investigator, maternal fetal medicine physician and chair and professor of Obstetrics and Gynecology.
Landon and Venkatesh and their research team at Ohio State will lead the multi-center study comprised of 20 other institutions, including maternal-fetal medicine specialists in diabetes in pregnancy, pediatricians, endocrinologists, statisticians, public health experts and patient advocates. Other key investigators at Ohio State include Maged Costantine, MD, professor of Obstetrics and Gynecology and chief of Maternal Fetal Medicine; Ann Scheck McAlearney, professor of family medicine, associate dean for Health Sciences Research, and director of Catalyst; and Saira Nawaz, PhD, research assistant professor of public health and Director of Health Services Research at the Center for HOPES.
The consortium is further supported by the Data Coordinating Center at George Washington University. The consortium has been thoughtfully established to ensure racial and ethnic, socioeconomic, urban and rural, and geographic diversity at both large academic and community-based sites across the U.S. The trial will enroll more than 1,500 pregnant individuals with gestational diabetes over three years and will follow all mothers and infants through at least two years of life.
“When completed, our study will be the largest comparative analysis of its kind and will inform the way we treat gestational diabetes for years to come,” said Venkatesh, who is also an assistant professor of obstetrics and gynecology at Ohio State College of Medicine.
The study was selected through a highly competitive review process in which patients, caregivers and other stakeholders joined scientists to evaluate the proposals. It was selected for funding through a PCORI program designed to support research that produces results that are broadly applicable to a diverse range of patients and care situations and can be more quickly taken up in routine clinical practice.
Many clinical studies test whether an approach to care works under carefully controlled conditions in specialized research centers, but health care is rarely delivered in such optimized situations and settings. Pragmatic clinical studies test a treatment’s effectiveness in “real-world” practice situations, such as typical hospitals and outpatient clinics and also can include a wider range of study participants, making their findings more generally \applicable.
Ohio State’s funding award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better informed healthcare decisions.
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