Evidence map›Paper›PMID 39317491›Full record

ArticleBMJ open2024

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, Cora MacPherson, Rebecca G Clifton, Camille E Powe, Anna Bartholomew, Donna Gregory, Anne Trinh, Ann Scheck McAlearney, Lauren G Fiechtner, Patrick Catalano and 27 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT06445946. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06445946 phase4recruiting

DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes

Ran2024Enrolled1,572Registered outcomes28Posted comparisons0ConditionsGestational Diabetes Mellitus, Pregnancy, High RiskArmsInsulin, Metformin
PMID 35412565PMID 34605130PMID 38049101other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

37 authors.

Kartik K VenkateshDepartment of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA kartik.venkatesh@osumc.edu.ORCID 0000-0002-8043-556X
Cora MacPhersonDepartment of Epidemiology, George Washington University School of Public Health and Health Services, Washington, District of Columbia, USA.
Rebecca G CliftonGeorge Washington University School of Public Health and Health Services, Washington, District of Columbia, USA.
Camille E PoweMassachusetts General Hospital, Boston, Massachusetts, USA.
Anna BartholomewCollege of Medicine, The Ohio State University, Columbus, Ohio, USA.
Donna GregoryDepartment of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA.
Anne TrinhThe Ohio State University, Columbus, Ohio, USA.
Ann Scheck McAlearneyThe Ohio State University, Columbus, Ohio, USA.
Lauren G FiechtnerMass General Hospital for Children, Boston, Massachusetts, USA.
Patrick CatalanoDepartment of Obstetrics and Gynecology, Tufts University, Medford, Oregon, USA.
Donna RiceDiabetesSisters, Raleigh, North Carolina, USA.
Sharon CrossThe Ohio State University, Columbus, Ohio, USA.
Huban KutayDepartment of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA.
Steven GabbeOhio State University College of Medicine, Columbus, Ohio, USA.
William A GrobmanThe Ohio State University, Columbus, Ohio, USA.
Maged M CostantineThe Ohio State University, Columbus, Ohio, USA.
Ashley N BattarbeeThe University of Alabama, Birmingham, Alabama, USA.
Kim BoggessThe University of North Carolina, Chapel Hill, North Carolina, USA.
Vivek KatukuriUniversity of New Mexico School of Medicine, Albuquerque, New Mexico, USA.
Kacey EichelbergerPrisma Health, Greenville, South Carolina, USA.
Tania EsakoffCedars-Sinai Medical Center, Los Angeles, California, USA.
Maisa N FeghaliUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Lori HarperThe University of Texas, Austin, Texas, USA.
Anjali KaimalUniversity of South Florida, Tampa, Florida, USA.
Martha Kole-WhiteBrown University, Providence, Rhode Island, USA.
Hector Mendez-FigueroaThe University of Texas Health Science Center, Houston, Texas, USA.
Malgorzata MlynarczykEVMS, Norfolk, Virginia, USA.
Anthony SciscioneChristiana Care Health Services Inc, Wilmington, Delaware, USA.
Lydia ShookMassachusetts General Hospital, Boston, Massachusetts, USA.
Nasim C SobhaniUCSF, San Francisco, California, USA.
David M StamilioWake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Erika WernerTufts Medical Center, Boston, Massachusetts, USA.
Samantha WiegandPremier Health Miami Valley Hospital, Dayton, Ohio, USA.
Chloe A ZeraDepartment of Obstetrics and Gynecology, BIDMC, Boston, Massachusetts, USA.
Noelia M ZorkColumbia University Irving Medical Center, New York, New York, USA.
George SaadeEVMS, Norfolk, Virginia, USA.
Mark B LandonDepartment of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA.

Funding

University of Alabama at Birmingham's Diabetes Research CenterP30DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BARBARA A GOWER · 2013 to 2026
$19.5M
NIDDK NIH HHS P30 DK079626
6 · The paper itself

Abstract

introductionGestational 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.

Indexed as

Diabetes, GestationalHypoglycemic AgentsInsulinMetforminAdultComparative Effectiveness ResearchFemaleHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicPregnancyPregnancy OutcomeUnited StatesHypoglycemic AgentsInsulinMetforminClinical TrialDiabetes in pregnancyMaternal medicineOBSTETRICSPregnancy

Identifiers

PMID39317491
PMCPMC11429521

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.