Changing patterns in medication prescription for gestational diabetes during a time of guideline change in the USA: a cross-sectional study.
K K Venkatesh, C W Chiang, W C Castillo...
https://pubmed.ncbi.nlm.nih.gov/34605130Actively Recruiting
Phase 4
Age: 18Years +
FEMALE
ID06445946
DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes
Led by Ohio State University · Updated on 2026-01-07
1572
Participants Needed
21
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for gestational diabetes mellitus (GDM), a common pregnancy complication that affects blood sugar control. This trial compares oral metformin and injectable insulin to see if metformin is not worse than insulin in reducing negative pregnancy outcomes. The study also looks at the safety of these treatments for both mothers and their children and explores patient experiences and factors affecting treatment use. The trial is a randomized controlled study involving 1,572 pregnant individuals across 20 U.S. sites, with follow-up through delivery and up to two years after birth. Participants will be randomly assigned to receive either metformin or insulin. Metformin can be given as immediate- or extended-release tablets, with doses increased up to a maximum of 2,500 mg daily; insulin may be added if blood sugar control is insufficient or if metformin causes side effects. Insulin treatment follows clinical guidelines with weight-based dosing and may include up to four daily injections of various insulin types, including rapid-, intermediate-, and long-acting forms. The study is open-label, meaning both participants and researchers know the treatment assigned. During the study, participants and their children will have regular assessments including monitoring of pregnancy and birth outcomes, maternal health, and child growth and development up to two years. Key measures include rates of large babies, low blood sugar, jaundice, and death in newborns, as well as child body mass index at age two. Other evaluations cover maternal weight gain, delivery details, and metabolic health. Patient-reported experiences with the treatments will be collected at 6 weeks and 2 years postpartum. Safety and treatment satisfaction will be closely monitored throughout the study period.
CONDITIONS
Brief Title
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy or twin pregnancy reduced to singleton before 14 weeks gestation
- Age 18 years or older
- Gestational age between 20 0/7 and 33 6/7 weeks at randomization
- Diagnosis of gestational diabetes mellitus at or before 33 6/7 weeks gestation
- Requires medication for glucose control with at least 30% elevated glucose values prior to randomization
- Willing and able to attend follow-up visits for two years postpartum
You will not qualify if you...
- Kidney disease with serum creatinine greater than 1.3 mg/dL
- Major structural malformation of the fetus
- Known fetal chromosome abnormalities
- Contraindications to metformin or insulin such as history of lactic acidosis, severe nausea and vomiting, or allergy
- Gestational diabetes diagnosed before 20 weeks with recent HbA1c greater than or equal to 6.5%
- Pregestational diabetes or prior HbA1c greater than or equal to 6.5%
- High fasting blood sugar levels (>115 mg/dL) for over half of recent measurements
- Participation in another trial affecting primary study outcomes
- Prenatal care or delivery planned where full medical records are inaccessible
- Language barriers without available translation
- Previous participation in this trial during an earlier pregnancy, unless only screened before
AI-Screening
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Your Study Journey
Screening
Duration - Up to 14 weeks from 20 to 33 weeks gestation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - From randomization until delivery
Participants receive pharmacotherapy with either oral metformin or injectable insulin to manage gestational diabetes during pregnancy.
Regular visits as per clinical care during pregnancy
Follow-up
Duration - Up to 2 years after delivery
Participants and their children are followed for up to 2 years postpartum to assess safety, outcomes, and patient-reported experiences.
Follow-up visits at 6 weeks postpartum and periodically up to 2 years
Trial Site Locations
Total: 21 locations
1
University of Alabama
Tuscaloosa, Alabama, United States, 35487
Actively Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
5
Tufts University
Boston, Massachusetts, United States, 02111
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Not Yet Recruiting
9
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
10
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
11
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
Actively Recruiting
12
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
13
Premier Health - Miami Valley Hospital
Dayton, Ohio, United States, 45409
Actively Recruiting
14
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
15
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
16
Brown University
Providence, Rhode Island, United States, 02912
Actively Recruiting
17
University of South Carolina Greenville
Greenville, South Carolina, United States, 29605
Actively Recruiting
18
University of Texas Austin
Austin, Texas, United States, 78705
Actively Recruiting
19
Austin Maternal Fetal Medicine
Austin, Texas, United States, 78758
Not Yet Recruiting
20
University of Texas Health Science Center
Houston, Texas, United States, 77030
Actively Recruiting
21
Eastern Virginia Medical School - Old Dominion University
Norfolk, Virginia, United States, 23501
Actively Recruiting
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Research Team
K
Kartik Venkatesh, MD, PhD
A
Anna Bartholomew, MPH, BS, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Patient Priorities, Decisional Comfort, and Satisfaction with Metformin versus Insulin for the Treatment of Gestational Diabetes Mellitus.
Kartik K Venkatesh, Jiqiang Wu, Anne Trinh...
https://pubmed.ncbi.nlm.nih.gov/38049101Risk of Adverse Pregnancy Outcomes Among Pregnant Individuals With Gestational Diabetes by Race and Ethnicity in the United States, 2014-2020.
Kartik K Venkatesh, Courtney D Lynch, Camille E Powe...
https://pubmed.ncbi.nlm.nih.gov/35412565Comparative 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...
https://pubmed.ncbi.nlm.nih.gov/39317491