Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-30 @ 5:42 PM
Study NCT ID:
NCT06774404
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flash Glucose Monitoring Targets in Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2025-01-08', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': 'Up to delivery', 'description': 'Average Fasting Glucose Concentration: Measured in mmol/L, calculated from fasting blood glucose readings and average Postprandial Glucose Concentration: Measured in mmol/L, based on glucose readings taken 60 minutes after main meals.'}], 'secondaryOutcomes': [{'measure': 'Mean Glucose (MG) in FSL+ SMBG group', 'timeFrame': 'Up to delivery', 'description': 'Measured in millimoles per liter (mmol/L), reflecting the average glucose level recorded by the sensor.'}, {'measure': 'Mean Amplitude of Glycemic Excursions (MAGE) (FSL+SMBG group)', 'timeFrame': 'Up to delivery', 'description': 'Measured in millimoles per liter (mmol/L), representing glycemic variability.'}, {'measure': 'Time in Range - TIR (SMBG+FSL group)', 'timeFrame': 'Up to delivery', 'description': 'Defined as the percentage (%) of time sensor glucose levels fall between 3,5 and 7,8 mmol/l'}, {'measure': 'Adherence to the Intervention', 'timeFrame': 'Up to delivery', 'description': 'Measured as the percentage (%) of completed prescribed self-monitoring and sensor glucose readings relative to the total number of prescribed measurements.'}, {'measure': 'Gestational Weight Gain (GWG)', 'timeFrame': 'Up to delivery', 'description': 'Measured in kilograms (kg), calculated as the difference between pre-pregnancy weight and the last recorded weight before delivery.'}, {'measure': 'Mode of Delivery', 'timeFrame': 'At delivery', 'description': 'Categorized into vaginal delivery, assisted vaginal delivery, or cesarean section, and reported as percentages (%) for each category.'}, {'measure': 'Occurrence of Hypertensive Disorders', 'timeFrame': 'Up to delivery', 'description': 'Reported as a binary outcome (Yes/No), based on clinical diagnosis during pregnancy.'}, {'measure': 'Birth Weight', 'timeFrame': 'At birth of infant', 'description': 'Measured in grams (g), recorded immediately after delivery'}, {'measure': 'Large-for-Gestational-Age (LGA) Infant', 'timeFrame': 'At birth of infant', 'description': 'Defined as birth weight above the 90th percentile for gestational age, reported as a binary outcome (Yes/No).'}, {'measure': 'Small-for-Gestational-Age (SGA) Infant', 'timeFrame': 'At birth of infant', 'description': 'Defined as birth weight below the 10th percentile for gestational age, reported as a binary outcome (Yes/No).'}, {'measure': 'Gestational Age at Birth', 'timeFrame': 'At birth of infant', 'description': 'Measured in completed weeks, based on the interval from the first day of the last menstrual period or ultrasound-confirmed dating.'}, {'measure': 'Neonatal Hypoglycemia', 'timeFrame': 'At birth of infant', 'description': 'Defined as blood glucose levels below 2.6 mmol/L in the first 48 hours of life, reported as a binary outcome (Yes/No).'}, {'measure': 'Pregnancy loss', 'timeFrame': '<28 days of life', 'description': 'Miscarriage, stillbirth, neonatal death'}, {'measure': 'Hyperbilirubinemia', 'timeFrame': 'Within first 7 days of life', 'description': 'Treated with phototherapy'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Gestational diabetes mellitus', 'Flash Glucose Monitoring', 'Pregnancy', 'FGM'], 'conditions': ['Gestational Diabetes Mellitus (GDM)']}, 'descriptionModule': {'briefSummary': 'The use of glucose monitoring sensors is already well-established in pregnant women with type 1 diabetes (T1D), where it has been proven to improve glycemic control and perinatal outcomes. However, it has not yet been sufficiently researched in the area of gestational diabetes (GDM). Some smaller studies have shown a favorable effect on glycemic control, but no statistically significant differences were observed in reducing perinatal complications. A randomized, prospective study will include 200 pregnant women with GDM, treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases at the University Medical Centre Ljubljana. Participants will be divided into two groups. The first group will measure subcutaneous glucose using FSL in addition to self-monitoring of blood glucose (SMBG) while fasting and 60 minutes after main meals at the same time intervals. In both groups, glycemic targets, maternal outcomes, and neonatal outcomes will be monitored. In the FSL + SMBG group, sensor parameters for glycemic control will also be tracked.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant women treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases for gestational diabetes (GDM),\n2. Agreement with the study protocol and ability to follow the study protocol,\n3. Diagnosis of GDM established using the standard recommended OGTT method between the 24th and 28th weeks of pregnancy,\n4. Age between 18 and 40 years.\n\nExclusion Criteria:\n\n1. History of bariatric surgery,\n2. Treatment with systemic corticosteroids for more than 14 days prior to inclusion in the study,\n3. Multiple pregnancy,\n4. Hospitalization for psychiatric illness within the last year,\n5. First visit to the Diabetes Outpatient Clinic after the 34th week of gestation.'}, 'identificationModule': {'nctId': 'NCT06774404', 'acronym': 'FlaG-TaG', 'briefTitle': 'Flash Glucose Monitoring Targets in Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Flash Glucose Monitoring Targets in Gestational Diabetes', 'orgStudyIdInfo': {'id': '0120-449/2021/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnant women with GDM using FGM and SMBG', 'description': 'Pregnant women with GDM using Flash Glucose Monitoring (FGM) and Self-Monitoring of Blood Glucose (SMBG)', 'interventionNames': ['Device: Use of FreeStyle Libre 14 day Flash Glucose Monitoring System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregnant women with GDM using only SMBG', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'Use of FreeStyle Libre 14 day Flash Glucose Monitoring System', 'type': 'DEVICE', 'description': 'Women with GDM in the intervention arm will use Flash Glucose Monitoring (FGM) from diagnosis until the end of pregnancy', 'armGroupLabels': ['Pregnant women with GDM using FGM and SMBG']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'Only using SMBG', 'armGroupLabels': ['Pregnant women with GDM using only SMBG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}