Glucose monitor study for gestational diabetes withdrawn before starting
NCT ID NCT06490874
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study was designed to see how well continuous glucose monitors (CGMs) work for pregnant women with gestational diabetes who need medication. It planned to compare blood sugar patterns in women taking metformin versus insulin during pregnancy and after delivery. However, the study was withdrawn before enrolling any participants, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Continuous glucose monitor (CGM) device
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A subset of 300 individuals (150 metformin, 150 insulin) will be consecutively enrolled in participating sites to this substudy from the 1,572 individuals from the parent DECIDE trial (NCT06445946).
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age. * Age \>18 years * Gestational age at randomization between 200/7 - 316/7 weeks based on project gestational age. * GDM diagnosis between 200/7 - 316/7 weeks based on project gestational age. * Requires medication for glucose control defined as ≥30% elevated glucose values (either fasting or postprandial or both) in the week prior to randomization per determination of the provider or documented in the medical record. * Patient willingness and ability to attend 2-year follow-up visit. * Patient willingness to wear and return a blinded CGM device. It is possible that some enrolled individuals may choose to use a separate CGM device for glucose monitoring as part of clinical care. Exclusion Criteria: * Renal disease (serum creatinine \>1.3 mg/dL) due to the potential impact of metformin on renal function. * Major structural malformation of the fetus. * Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening. * Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis. * Pregestational diabetes documented in the medical record, GDM diagnosis \<20 weeks, or prior A1c\>6.5% * Fasting hyperglycemia \>115 mg/dl for ≥50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia). * Enrolled in a trial that influences primary study outcomes of the parent DECIDE trial (composite neonatal outcome at delivery or childhood body mass index at 2 years). * Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff. * Language barrier (appropriate translation resources unavailable at the site). * Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included. * In addition, individuals who report a prior allergy or sensitivity to CGM will also be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Premier Health - Miami Valley Hospital
Dayton, Ohio, 45409, United States
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The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210, United States
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University of Alabama
Tuscaloosa, Alabama, 35487, United States
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