[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635869":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":35,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous Glucose Monitoring (CGM)","EXPERIMENTAL","Participants randomized to this arm will use a real-time continuous glucose monitoring system (FreeStyle Libre 2) from randomization (24-28 weeks of gestation) until delivery. The sensor will be placed by trained staff, and participants will receive standardized training on device use and interpretation of glucose trends. Clinical decisions, including dietary adjustments and initiation or titration of insulin therapy, will be based on CGM data according to local gestational diabetes protocols. A capillary glucose meter will be provided for confirmatory measurements if needed. All other aspects of care will follow standard practice.",[13],"Device: Continuous Glucose Monitoring (FreeStyle Libre 2)",{"label":15,"type":16,"description":17,"interventionNames":18},"Self-Monitoring of Blood Glucose (SMBG)","ACTIVE_COMPARATOR","Participants randomized to this arm will perform standard self-monitoring of blood glucose using capillary finger-prick measurements (typically fasting and postprandial values, 4-6 times daily) from randomization until delivery. Participants will receive standardized education on measurement technique and recording. Clinical decisions, including dietary adjustments and insulin initiation or titration, will be based on SMBG values according to local gestational diabetes protocols. All other aspects of care, including obstetric follow-up, will follow standard clinical practice.",[19],"Device: Self-Monitoring of Blood Glucose (Capillary Glucose Meter)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Continuous Glucose Monitoring (FreeStyle Libre 2)","Use of a CE-marked continuous glucose monitoring system (FreeStyle Libre 2) from randomization (24-28 weeks of gestation) until delivery. The sensor measures interstitial glucose continuously and provides real-time glucose values and trend information. Data are reviewed during routine visits or remotely and used to guide clinical management of gestational diabetes, including lifestyle adjustments and insulin initiation or titration when required. A capillary glucose meter may be used to confirm discordant readings.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Self-Monitoring of Blood Glucose (Capillary Glucose Meter)","Standard capillary self-monitoring of blood glucose using a CE-marked glucose meter from randomization until delivery. Participants perform fasting and postprandial finger-prick measurements (typically 4-6 times daily). Glucose values are reviewed during routine visits or remotely and used to guide clinical management of gestational diabetes, including dietary adjustments and insulin initiation or titration according to local protocols.",[15],[32],{"name":33,"affiliation":5,"role":34},"Federico Migliorelli, MD, PhD","PRINCIPAL_INVESTIGATOR",[36],{"facility":37,"status":26,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital Clínic de Barcelona","Barcelona","08028","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],2.15899,41.38879,{"lat":46,"lon":45},[49,53,54,57,59],{"name":33,"role":50,"phone":51,"phoneExt":26,"email":52},"CONTACT","(+34)932275400","fmiguore@clinic.cat",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":55,"role":56,"phone":26,"phoneExt":26,"email":26},"Clara Murillo, MD, PhD","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":26,"phoneExt":26,"email":26},"Irene Vinagre, MD, PhD",{"name":60,"role":56,"phone":26,"phoneExt":26,"email":26},"Daria Roca",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[64],{"name":65,"class":66},"Fundación Sociedad Española de Diabetes","UNKNOWN","100635869","continuous-glucose-monitoring-versus-self-monitoring-of-blood-glucose-in-women-with-gestational-diabetes-100635869",false,"NCT07558291","Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes","Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes: A Pilot Randomized Clinical Trial","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years\n* Singleton pregnancy\n* Diagnosis of gestational diabetes mellitus (GDM) according to local two-step protocol (abnormal 50 g glucose challenge test followed by abnormal 100 g oral glucose tolerance test with at least 2 abnormal values)\n* Gestational age between 24 and 28 weeks at time of GDM diagnosis\n* Access to a compatible smartphone or digital device with internet connection to allow synchronization and remote upload of glucose data (CGM or SMBG)\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Preexisting type 1 or type 2 diabetes mellitus\n* History of bariatric surgery\n* Treatment with metformin during pregnancy\n* Chronic systemic corticosteroid therapy\n* Known contraindications to use of a CGM sensor (e.g., severe dermatologic conditions at insertion site)\n* Inability to comply with study procedures or follow-up","FEMALE","18 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","Gestational diabetes mellitus (GDM) is a type of diabetes that is first diagnosed during pregnancy. It causes high blood sugar levels and can increase the risk of health problems for both the mother and the baby. Babies may grow larger than expected (macrosomia), which can make delivery more difficult and increase the risk of birth complications. Mothers with GDM are also more likely to need insulin treatment and may have a higher risk of high blood pressure during pregnancy. Good blood sugar control is important to reduce these risks.\n\nThe usual way to monitor blood sugar in women with GDM is by self-monitoring of blood glucose (SMBG). This involves pricking the finger several times a day to measure blood sugar levels. Although this method provides useful information, it only shows glucose levels at specific moments and may miss changes that happen during the night or between measurements.\n\nContinuous glucose monitoring (CGM) is a newer method that uses a small sensor placed under the skin to measure glucose levels throughout the day and night. It provides more detailed information about blood sugar patterns and does not require frequent finger pricks. CGM has been shown to improve blood sugar control in people with type 1 and type 2 diabetes, but its benefits in women with gestational diabetes are not yet fully known.\n\nThe purpose of this study is to compare continuous glucose monitoring (CGM) with standard finger-prick monitoring (SMBG) in pregnant women diagnosed with gestational diabetes between 24 and 28 weeks of pregnancy. The study will evaluate whether CGM is practical to use, whether women are satisfied with it, and whether it may help improve blood sugar control and pregnancy outcomes.\n\nA total of 100 pregnant women with gestational diabetes will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups:\n\nOne group will use a continuous glucose monitoring device.\n\nThe other group will continue with standard finger-prick blood glucose monitoring.\n\nBoth groups will receive the same medical care, including dietary advice, physical activity recommendations, and insulin treatment if needed. Participants will attend regular pregnancy visits every 2 to 3 weeks until delivery, as part of usual care. No extra hospital visits are required because of the study. Women using CGM will receive training on how to use the device.\n\nThe researchers will compare blood sugar control, the need for insulin, pregnancy complications, and newborn outcomes such as birth weight and episodes of low blood sugar after birth. The study will also assess how satisfied women are with their glucose monitoring method and how it affects their quality of life.\n\nThis is a pilot study, which means its main goal is to determine whether a larger study should be carried out in the future. The results will help researchers understand whether continuous glucose monitoring could improve the care of women with gestational diabetes and their babies.",[84],"Gestational Diabetes Mellitus (GDM)",[86,87,88,89,90],"Gestational Diabetes Mellitus","Continuous Glucose Monitoring","Glycemic Control","Patient-Reported Outcomes","Self-Monitoring of Blood Glucose","NOT_YET_RECRUITING","2026-05-12",{"date":94,"type":95},"2026-05-14","ACTUAL",{"date":97,"type":78},"2026-07-01",{"date":99,"type":78},"2027-05-31",{"name":5,"class":6},1]