[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550351":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":458,"collaborators":461,"id":466,"slug":24,"hasResults":467,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":467,"sex":473,"minAge":474,"maxAge":24,"enrollmentInfo":475,"targetDuration":24,"studyType":478,"phases":479,"briefSummary":481,"conditions":482,"keywords":485,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":500},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","EXPERIMENTAL","Metformin as either immediate- or extended-release formulations can be utilized, and titrated to a maximum daily dose of 2,500 mg. Participants receiving metformin will have insulin added only if they have not achieved euglycemia for at least 30% of glucose values after generally receiving the maximum daily dose of metformin of 2,500 mg, or in select situations in the setting of participant intolerance due to mild gastrointestinal symptoms. Participants will be asked to continue taking metformin after treatment supplementation with insulin.",[13],"Drug: Metformin",{"label":15,"type":10,"description":16,"interventionNames":17},"Insulin","Insulin will be initiated utilizing clinical standards using trimester-specific weight-based dosing criteria, including both basal and prandial insulins for up to a total of 4 daily injections. Consistent with clinical practice, some people may be managed with a single dose of intermediate- or long-acting insulin at night to treat isolated fasting hyperglycemia, while others may require additional treatment of postprandial hyperglycemia with shorter-acting insulin. The sites' insulin formularies include rapid- (Novolog and Humalog), intermediate- (Humulin N, Novolin N, and NPH), and long-acting insulins (Detemir and Lantus).",[18],"Drug: Insulin",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Individuals randomized to this arm will receive oral metformin tablets for their Gestational diabetes mellitus treatment.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Individuals randomized to this arm will receive injectable insulin for their Gestational diabetes mellitus treatment.",[15],[29],{"name":30,"affiliation":5,"role":31},"Kartik Venkatesh, MD, PhD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","614-293-2222","kartik.venkatesh@osumc.edu",{"name":38,"role":34,"phone":39,"phoneExt":24,"email":40},"Anna Bartholomew, MPH, BS, 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Fong","magie.fong@ucsf.edu",{"name":93,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":48,"countryCode":49,"cosmosGeoPoint":105,"geoPoint":109,"contacts":24},"Christiana Care","WITHDRAWN","Newark","Delaware","19718",{"type":51,"coordinates":106},[107,108],-75.74966,39.68372,{"lat":108,"lon":107},{"facility":111,"status":44,"city":112,"state":113,"zip":114,"country":48,"countryCode":49,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University of South Florida","Tampa","Florida","33620",{"type":51,"coordinates":116},[117,118],-82.45843,27.94752,{"lat":118,"lon":117},[121,124,127],{"name":122,"role":34,"phone":24,"phoneExt":24,"email":123},"Anjali Kaimal Kaimal, MD","akaimal@usf.edu",{"name":125,"role":34,"phone":24,"phoneExt":24,"email":126},"Maha Jumaily","mahaaljumaily@usf.edu",{"name":128,"role":31,"phone":24,"phoneExt":24,"email":24},"Anjali Kaimal, MD",{"facility":130,"status":44,"city":131,"state":132,"zip":133,"country":48,"countryCode":49,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Tufts University","Boston","Massachusetts","02111",{"type":51,"coordinates":135},[136,137],-71.05977,42.35843,{"lat":137,"lon":136},[140,143,146,147],{"name":141,"role":34,"phone":24,"phoneExt":24,"email":142},"Erika Werner, MD","erika.werner@tuftsmedicine.org",{"name":144,"role":34,"phone":24,"phoneExt":24,"email":145},"Beth Marsh","Beth.Marsh@tuftsmedicine.org",{"name":141,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":148,"role":149,"phone":24,"phoneExt":24,"email":24},"Patrick Catalano, MD","SUB_INVESTIGATOR",{"facility":151,"status":44,"city":131,"state":132,"zip":152,"country":48,"countryCode":49,"cosmosGeoPoint":153,"geoPoint":155,"contacts":156},"Massachusetts General Hospital","02114",{"type":51,"coordinates":154},[136,137],{"lat":137,"lon":136},[157,160,163,164,166],{"name":158,"role":34,"phone":24,"phoneExt":24,"email":159},"Lydia Shook, MD","lshook@mgh.harvard.edu",{"name":161,"role":34,"phone":24,"phoneExt":24,"email":162},"Nancy Kingori","nkingori@mgb.org",{"name":158,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":165,"role":149,"phone":24,"phoneExt":24,"email":24},"Camille Powe, MD",{"name":167,"role":149,"phone":24,"phoneExt":24,"email":24},"Lauren Fiechtner, MD",{"facility":169,"status":170,"city":131,"state":132,"zip":171,"country":48,"countryCode":49,"cosmosGeoPoint":172,"geoPoint":174,"contacts":24},"Beth Israel Deaconess Medical Center","TERMINATED","02215",{"type":51,"coordinates":173},[136,137],{"lat":137,"lon":136},{"facility":176,"status":44,"city":177,"state":178,"zip":179,"country":48,"countryCode":49,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Washington University in St. Louis","St Louis","Missouri","63130",{"type":51,"coordinates":181},[182,183],-90.19789,38.62727,{"lat":183,"lon":182},[186,189,193],{"name":187,"role":34,"phone":24,"phoneExt":24,"email":188},"Megan Lawlor, MD","lawlor@wustl.edu",{"name":190,"role":34,"phone":191,"phoneExt":24,"email":192},"Emily Diveley, BSN, RN","314-362-4685","diveley@wustl.edu",{"name":194,"role":149,"phone":24,"phoneExt":24,"email":24},"Sydney Thayer, MD",{"facility":196,"status":44,"city":197,"state":198,"zip":199,"country":48,"countryCode":49,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"University of New Mexico","Albuquerque","New Mexico","87131",{"type":51,"coordinates":201},[202,203],-106.65114,35.08449,{"lat":203,"lon":202},[206,209,212],{"name":207,"role":34,"phone":24,"phoneExt":24,"email":208},"Vivek Katukuri, MD","vkatukuri@salud.unm.edu",{"name":210,"role":34,"phone":24,"phoneExt":24,"email":211},"Karen 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Carolina","27599",{"type":51,"coordinates":236},[237,238],-79.05584,35.9132,{"lat":238,"lon":237},{"facility":241,"status":44,"city":242,"state":233,"zip":243,"country":48,"countryCode":49,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Wake Forest University","Winston-Salem","27106",{"type":51,"coordinates":245},[246,247],-80.24422,36.09986,{"lat":247,"lon":246},[250,253,256],{"name":251,"role":34,"phone":24,"phoneExt":24,"email":252},"David Stamilio, MD","dstamili@wakehealth.edu",{"name":254,"role":34,"phone":24,"phoneExt":24,"email":255},"Christina Tulbert","ctulbert@wakehealth.edu",{"name":251,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":258,"status":44,"city":259,"state":260,"zip":261,"country":48,"countryCode":49,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"The Ohio State University Wexner Medical Center OB\u002FGYN Maternal and Fetal Medicine","Columbus","Ohio","43210",{"type":51,"coordinates":263},[264,265],-82.99879,39.96118,{"lat":265,"lon":264},[268,270,271,273,275,277,279,281],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":269},"Kartik.Venkatesh@osumc.edu",{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":272,"role":31,"phone":24,"phoneExt":24,"email":24},"Mark Landon, MD",{"name":274,"role":149,"phone":24,"phoneExt":24,"email":24},"Maged Costantine, MD, MBA",{"name":276,"role":149,"phone":24,"phoneExt":24,"email":24},"Ann S McAlearney, ScD",{"name":278,"role":149,"phone":24,"phoneExt":24,"email":24},"Anne Trinh, MPH",{"name":280,"role":149,"phone":24,"phoneExt":24,"email":24},"Steven Gabbe, MD",{"name":282,"role":149,"phone":24,"phoneExt":24,"email":24},"Christine Field, MD",{"facility":284,"status":44,"city":285,"state":260,"zip":286,"country":48,"countryCode":49,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"Premier Health - Miami Valley Hospital","Dayton","45409",{"type":51,"coordinates":288},[289,290],-84.19161,39.75895,{"lat":290,"lon":289},[293,296,299],{"name":294,"role":34,"phone":24,"phoneExt":24,"email":295},"Samantha Wiegand, MD","slwiegand@premierhealth.com",{"name":297,"role":34,"phone":24,"phoneExt":24,"email":298},"Emily Reynolds","ESReynolds@premierhealth.com",{"name":294,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":301,"status":302,"city":303,"state":260,"zip":304,"country":48,"countryCode":49,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Kettering Health","NOT_YET_RECRUITING","Kettering","45429",{"type":51,"coordinates":306},[307,308],-84.16883,39.6895,{"lat":308,"lon":307},[311,315],{"name":312,"role":34,"phone":313,"phoneExt":24,"email":314},"Hind Moussa, MD","937-610-3220","Hind.Moussa@ketteringhealth.org",{"name":316,"role":34,"phone":24,"phoneExt":24,"email":317},"Michelle Pershing","Michelle.Pershing@ketteringhealth.org",{"facility":319,"status":44,"city":320,"state":321,"zip":322,"country":48,"countryCode":49,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":51,"coordinates":324},[325,326],-75.16362,39.95238,{"lat":326,"lon":325},[329,333],{"name":330,"role":34,"phone":331,"phoneExt":24,"email":332},"Celeste Durnwald, MD","215-615-3817","Celeste.Durnwald@pennmedicine.upenn.edu",{"name":334,"role":34,"phone":331,"phoneExt":24,"email":335},"Elizabeth Norton, MPH, MBE","Elizabeth.Norton@pennmedicine.upenn.edu",{"facility":337,"status":44,"city":338,"state":321,"zip":339,"country":48,"countryCode":49,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"University of Pittsburgh","Pittsburgh","15213",{"type":51,"coordinates":341},[342,343],-79.99589,40.44062,{"lat":343,"lon":342},[346,349,352],{"name":347,"role":34,"phone":24,"phoneExt":24,"email":348},"Maisa Feghali, MD","feghalim@mwri.magee.edu",{"name":350,"role":34,"phone":24,"phoneExt":24,"email":351},"John Collins","collinsjn@mwri.magee.edu",{"name":347,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":354,"status":44,"city":355,"state":356,"zip":357,"country":48,"countryCode":49,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"Brown University","Providence","Rhode Island","02912",{"type":51,"coordinates":359},[360,361],-71.41283,41.82399,{"lat":361,"lon":360},[364,367,370],{"name":365,"role":34,"phone":24,"phoneExt":24,"email":366},"Martha Kole-White, MD","mkolewhite@kentri.org",{"name":368,"role":34,"phone":24,"phoneExt":24,"email":369},"Kelsey Inglesby","KInglesby@Wihri.org",{"name":365,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":372,"status":44,"city":373,"state":374,"zip":375,"country":48,"countryCode":49,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"University of South Carolina Greenville","Greenville","South Carolina","29605",{"type":51,"coordinates":377},[378,379],-82.39401,34.85262,{"lat":379,"lon":378},[382,385,388],{"name":383,"role":34,"phone":24,"phoneExt":24,"email":384},"Kacey Eichelberger, MD","kacey.eichelberger@prismahealth.org",{"name":386,"role":34,"phone":24,"phoneExt":24,"email":387},"Patti Parker","patti.parker@prismahealth.org",{"name":383,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":390,"status":44,"city":391,"state":392,"zip":393,"country":48,"countryCode":49,"cosmosGeoPoint":394,"geoPoint":398,"contacts":399},"University of Texas Austin","Austin","Texas","78705",{"type":51,"coordinates":395},[396,397],-97.74306,30.26715,{"lat":397,"lon":396},[400,403,406],{"name":401,"role":34,"phone":24,"phoneExt":24,"email":402},"Lorie Harper, MD","lorie.harper@austin.utexas.edu",{"name":404,"role":34,"phone":24,"phoneExt":24,"email":405},"Mickey Roberts","Mickey.roberts@austin.utexas.edu",{"name":401,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":408,"status":302,"city":391,"state":392,"zip":409,"country":48,"countryCode":49,"cosmosGeoPoint":410,"geoPoint":412,"contacts":413},"Austin Maternal Fetal Medicine","78758",{"type":51,"coordinates":411},[396,397],{"lat":397,"lon":396},[414,417],{"name":415,"role":34,"phone":416,"phoneExt":24,"email":24},"Mollie McDonnold, MD","512-821-2540",{"name":418,"role":34,"phone":419,"phoneExt":24,"email":420},"Heather Azarmehr, MSN, RN","737-415-6210","Heather.Azarmehr@stdavids.com",{"facility":422,"status":44,"city":423,"state":392,"zip":424,"country":48,"countryCode":49,"cosmosGeoPoint":425,"geoPoint":429,"contacts":430},"University of Texas Health Science Center","Houston","77030",{"type":51,"coordinates":426},[427,428],-95.36327,29.76328,{"lat":428,"lon":427},[431,434,437],{"name":432,"role":34,"phone":24,"phoneExt":24,"email":433},"Hector Mendez-Figueroa, MD","hector.mendezfigueroa@uth.tmc.edu",{"name":435,"role":34,"phone":24,"phoneExt":24,"email":436},"Laura Nixon","Laura.Nixon@uth.tmc.edu",{"name":432,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":439,"status":44,"city":440,"state":441,"zip":442,"country":48,"countryCode":49,"cosmosGeoPoint":443,"geoPoint":447,"contacts":448},"Eastern Virginia Medical School - Old Dominion University","Norfolk","Virginia","23501",{"type":51,"coordinates":444},[445,446],-76.28522,36.84681,{"lat":446,"lon":445},[449,452,455,456],{"name":450,"role":34,"phone":24,"phoneExt":24,"email":451},"Malgorzata Mlynarczyk, MD","mlynarm@evms.edu",{"name":453,"role":34,"phone":24,"phoneExt":24,"email":454},"Cheryl Sparrer","SparreCD@evms.edu",{"name":450,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":457,"role":149,"phone":24,"phoneExt":24,"email":24},"George Saade, MD",{"type":31,"investigatorFullName":459,"investigatorTitle":460,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Kartik K Venkatesh","Assistant Professor",[462,464],{"name":463,"class":6},"Patient-Centered Outcomes Research Institute",{"name":465,"class":6},"The George Washington University Biostatistics Center","100550351",false,"NCT06445946","DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes","DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes","DECIDE","Inclusion Criteria:\n\n* Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.\n* Age 18 years or older\n* Gestational age at randomization between 20 0\u002F7 - 33 6\u002F7 weeks based on project gestational age.\n* GDM diagnosis less than or equal to 33 6\u002F7 weeks based on project gestational age.\n* Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) prior to randomization per determination of the provider or documented in the medical record.\n* Patient willingness and ability to attend 2-year follow-up visit.\n\nExclusion criteria:\n\n* Renal disease (serum creatinine \\>1.3 mg\u002FdL) due to the potential impact of metformin on renal function.\n* Major structural malformation of the fetus.\n* Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.\n* Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and\u002For anaphylaxis.\n* For individuals with GDM diagnosed \\\u003C20 0\u002F7 weeks, documented A1c ≥\\>6.5% within prior 6 months.\n* Pregestational diabetes documented in the medical record or prior A1c\\>= 6.5%\n* Fasting hyperglycemia \\>115 mg\u002Fdl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).\n* Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years).\n* Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.\n* Language barrier (appropriate translation resources unavailable at the site)\n* Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.","FEMALE","18 Years",{"count":476,"type":477},1572,"ESTIMATED","INTERVENTIONAL",[480],"PHASE4","This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin.\n\nThis study 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. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.",[483,484],"Gestational Diabetes Mellitus","Pregnancy, High Risk",[15,486,487,9,488,489,490],"Pregnancy","Glycemic control","Gestational diabetes","Diabetes","Adverse pregnancy outcomes","2026-06-24",{"date":493,"type":494},"2026-06-25","ACTUAL",{"date":496,"type":494},"2024-08-01",{"date":498,"type":477},"2030-12",{"name":5,"class":6},24]