Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-06 @ 4:07 PM
Study NCT ID:
NCT05062460
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2021-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucose Testing in GDM: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001786', 'term': 'Blood Glucose'}], 'ancestors': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adherence', 'timeFrame': 'During the intervention', 'description': 'Evaluate rate of adherence (binary outcome defined as \\<80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.'}], 'secondaryOutcomes': [{'measure': 'Percentage of postprandial glucose log complete, averaged over the duration of the study period', 'timeFrame': 'During the intervention'}, {'measure': 'Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period', 'timeFrame': 'During the intervention'}, {'measure': 'Percentage of elevated blood glucose values per week, averaged over the duration of the study period', 'timeFrame': 'During the intervention'}, {'measure': 'Number of patients who start insulin or oral hyperglycemic medication therapy prior to delivery.', 'timeFrame': 'During the intervention'}, {'measure': 'Gestational age at medication therapy initiation', 'timeFrame': 'During the intervention'}, {'measure': 'Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy', 'timeFrame': 'During the intervention'}, {'measure': 'Number of subjects with a vaginal delivery', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of subjects with an operative delivery', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of subjects with a caesarean section delivery', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of subjects with a preeclampsia diagnosis', 'timeFrame': 'During intervention'}, {'measure': 'Neonatal birthweight', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of subjects with shoulder dystocia', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of patients with 3rd or 4th degree perineal lacerations', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of patients with postpartum hemorrhage.', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of stillbirths', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of NICU admissions', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of patients requiring supplemental oxygen support', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of patients with diagnosis of hypoglycemia', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of patients with diagnosis of hyperbilirubinemia', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of patients with clavicular fracture', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of patients with humeral fracture', 'timeFrame': 'At time of delivery'}, {'measure': 'Number of patients with brachial plexus palsy', 'timeFrame': 'At time of delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating.\n\nThe primary objective of this study is to evaluate difference in rate of adherence (binary outcome defined as \\<80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.', 'detailedDescription': 'Consented patients who are diagnosed with gestational diabetes will be randomized to either 1-hour or 2-hour postprandial blood glucose monitoring. A retrospective chart review from July 2020 until study commencement for patients from the same clinic will be used as a historical control group. This study will assess differences in adherence to testing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant patients with singleton gestation who are ≥ 18 years of age.\n* Diagnosis of GDM after 24 0/7 weeks.\n* For diagnosing GDM, a two-step screening algorithm will be performed according to the American College of Obstetrics and Gynecologists.4 Specifically, a 1-hour 50-g glucose-loading test is given first. Plasma glucose levels between 140 and 200 mg/dL will be considered elevated. Confirmatory testing will then be performed using a 3-hour 100-g glucose tolerance test. Diagnosis was made when two of the four values were elevated. Abnormal glucose value thresholds are established via the criteria suggested by Carpenter and Coustan: fasting value ≥ 95 mg/dL, 1-hour ≥ 180 mg/dL, 2-hour ≥ 155 mg/dL, and 3-hour ≥ 140 mg/dL.9 Patients with a blood glucose level greater than 200 mg/dL after 1-hour 50-g glucose-loading test will be diagnosed with GDM without requirement for the 3-hour 100-g glucose tolerance test.\n\nExclusion Criteria:\n\n* Type 1 pre-gestational diabetes\n* Type 2 pre-gestational diabetes\n* GDM diagnosed prior to 24 0/7 weeks gestation.'}, 'identificationModule': {'nctId': 'NCT05062460', 'briefTitle': 'Glucose Testing in GDM: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics: A Randomized Trial', 'orgStudyIdInfo': {'id': '20-10022829'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1-hour post-prandial blood glucose monitoring Arm', 'description': 'Arm in which participants are randomized to blood glucose monitoring at 1 hour after eating.', 'interventionNames': ['Other: 1 hour Blood glucose monitoring']}, {'type': 'OTHER', 'label': '2-hour post-prandial blood glucose monitoring Arm', 'description': 'Arm in which participants are randomized to blood glucose monitoring at 2 hours after eating.', 'interventionNames': ['Other: 2 hour blood glucose monitoring']}], 'interventions': [{'name': '1 hour Blood glucose monitoring', 'type': 'OTHER', 'description': 'Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.', 'armGroupLabels': ['1-hour post-prandial blood glucose monitoring Arm']}, {'name': '2 hour blood glucose monitoring', 'type': 'OTHER', 'description': 'Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring', 'armGroupLabels': ['2-hour post-prandial blood glucose monitoring Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Prebyterian Hospital Weill Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Stephen Chasen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}