Comparative effectiveness trial of metformin versus insulin for the treatment of gestational diabetes in the USA: clinical trial protocol for the multicentre DECIDE study

Kartik K. Venkatesh, Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA kartik.venkatesh@osumc.edu.
Cora MacPherson, Department of Epidemiology, George Washington University School of Public Health and Health Services, Washington, District of Columbia, USA.
Rebecca G. Clifton, George Washington University School of Public Health and Health Services, Washington, District of Columbia, USA.
Camille E. Powe, Massachusetts General Hospital, Boston, Massachusetts, USA.
Anna Bartholomew, College of Medicine, The Ohio State University, Columbus, Ohio, USA.
Donna Gregory, Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA.
Anne Trinh, The Ohio State University, Columbus, Ohio, USA.
Ann Scheck McAlearney, The Ohio State University, Columbus, Ohio, USA.
Lauren G. Fiechtner, Mass General Hospital for Children, Boston, Massachusetts, USA.
Patrick Catalano, Department of Obstetrics and Gynecology, Tufts University, Medford, Oregon, USA.
Donna Rice, DiabetesSisters, Raleigh, North Carolina, USA.
Sharon Cross, The Ohio State University, Columbus, Ohio, USA.
Huban Kutay, Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA.
Steven Gabbe, Ohio State University College of Medicine, Columbus, Ohio, USA.
William A. Grobman, The Ohio State University, Columbus, Ohio, USA.
Maged M. Costantine, The Ohio State University, Columbus, Ohio, USA.
Ashley N. Battarbee, The University of Alabama, Birmingham, Alabama, USA.
Kim Boggess, The University of North Carolina, Chapel Hill, North Carolina, USA.
Vivek Katukuri, University of New Mexico School of Medicine, Albuquerque, New Mexico, USA.
Kacey Eichelberger, Prisma Health, Greenville, South Carolina, USA.
Tania Esakoff, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Maisa N. Feghali, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Lori Harper, The University of Texas, Austin, Texas, USA.
Anjali Kaimal, University of South Florida, Tampa, Florida, USA.
Martha Kole-White, Brown University, Providence, Rhode Island, USA.
Hector Mendez-Figueroa, The University of Texas Health Science Center, Houston, Texas, USA.
Malgorzata Mlynarczyk, EVMS, Norfolk, Virginia, USA.
Anthony Sciscione, Christiana Care Health Services Inc, Wilmington, Delaware, USA.
Lydia Shook, Massachusetts General Hospital, Boston, Massachusetts, USA.
Nasim C. Sobhani, UCSF, San Francisco, California, USA.
David M. Stamilio, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Erika Werner, Tufts Medical Center, Boston, Massachusetts, USA.

Document Type

Journal Article

Publication Date

9-24-2024

Journal

BMJ open

Volume

14

Issue

9

DOI

10.1136/bmjopen-2024-091176

Keywords

Clinical Trial; Diabetes in pregnancy; Maternal medicine; OBSTETRICS; Pregnancy

Abstract

INTRODUCTION: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the affected pregnant individual and the infant exposed in utero. One in four individuals with GDM will require pharmacotherapy to achieve glycaemic control. Injectable insulin has been the mainstay of pharmacotherapy. Oral metformin is an alternative option increasingly used in clinical practice. Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterised, adequately powered study of a diverse US population remain lacking. Because metformin crosses the placenta, long-term safety data, in particular, the risk of childhood obesity, from exposed children are also needed. In addition, the patient-reported experiences of individuals with GDM requiring pharmacotherapy remain to be characterised, including barriers to and facilitators of metformin versus insulin use. METHODS AND ANALYSIS: In a two-arm open-label, pragmatic comparative effectiveness randomised controlled trial, we will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. We plan to recruit 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites using consistent diagnostic and treatment criteria for oral metformin versus injectable insulin and follow them and their children through delivery to 2 years post partum. More information is available at www.decidestudy.org. ETHICS AND DISSEMINATION: The Institutional Review Board at The Ohio State University approved this study (IRB: 2024H0193; date: 7 December 2024). We plan to submit manuscripts describing the results of each study aim, including the pregnancy outcomes, the 2-year follow-up outcomes, and mixed-methods assessment of patient experiences for publication in peer-reviewed journals and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT06445946.

Department

Epidemiology

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