Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-03-28 @ 8:29 AM
Study NCT ID:
NCT05326204
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2022-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1 Versus 2 Hours Post Meal Glucose Monitoring in Gestational Diabetes on Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], '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'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015190', 'term': 'Blood Glucose Self-Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D000085263', 'term': 'Self-Testing'}, {'id': 'D012648', 'term': 'Self Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2954}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mode of delivery', 'timeFrame': 'from point of randomization to birth of the neonate', 'description': 'route'}, {'measure': 'Gestational age', 'timeFrame': 'from point of randomization to birth of the neonate', 'description': 'in weeks'}, {'measure': 'Fetal weight', 'timeFrame': 'from point of randomization to birth of the neonate', 'description': 'in gram'}], 'secondaryOutcomes': [{'measure': 'Maternal complications', 'timeFrame': 'from point of randomization to birth of the neonate', 'description': 'postpartum haemorrhage, perineal tear'}, {'measure': 'perinatal complications', 'timeFrame': 'from point of randomization to birth of the neonate', 'description': 'intrauterine death, macrosomia, admission to neonatal intensive care unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational diabetes', 'treatment', 'glucose monitoring'], 'conditions': ['Gestational Diabetes', 'Treatment Adherence']}, 'descriptionModule': {'briefSummary': 'A study to compare between 1 and 2 hours post meal blood glucose monitoring in patients with Gestational Diabetes Mellitus requiring treatment.', 'detailedDescription': 'This study involves all pregnant women who attended our antenatal clinic with Gestational Diabetes Mellitus requiring treatment. They will be randomised to either 1 or 2 hours post meal self blood glucose monitoring. The blood sugar profile is a staggered 7 points. They are followed up in the research clinic until delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women with gestational diabetes on treatment attending the antenatal clinic in our centre', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational diabetes diagnosed based on National Institute for Health and Care Excellence guideline\n* requiring treatment either with metformin alone or combined with insulin\n\nExclusion Criteria:\n\n* type 1 and 2 diabetes\n* bad obstetrics history\n* underlying medical disorders such as Systemic Lupus Erythematosus\n* fetal anomaly\n* delivery elsewhere'}, 'identificationModule': {'nctId': 'NCT05326204', 'briefTitle': '1 Versus 2 Hours Post Meal Glucose Monitoring in Gestational Diabetes on Treatment', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': '1 Versus 2 Hours Post Meal Self Monitoring Blood Glucose in Gestational Diabetes Mellitus on Treatment-A Prospective Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'FF-2022-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 hour', 'description': 'Blood glucose monitoring comprises of 1 hour post meal', 'interventionNames': ['Other: Home blood glucose monitoring']}, {'label': '2 hours', 'description': 'Blood glucose monitoring comprises of 2 hours post meal', 'interventionNames': ['Other: Home blood glucose monitoring']}], 'interventions': [{'name': 'Home blood glucose monitoring', 'type': 'OTHER', 'description': 'Self monitoring of capillary blood glucose', 'armGroupLabels': ['1 hour', '2 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Kuala Lumpur', 'state': 'W.Persekutuan', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Rahana Abd Rahman', 'role': 'CONTACT', 'email': 'drrahana@ppukm.ukm.edu.my', 'phone': '+60122719985'}], 'facility': 'UKM Medical Center', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Rahana Abd Rahman', 'role': 'CONTACT', 'email': 'drrahana@ppukm.ukm.edu.my', 'phone': '+60122719985'}, {'name': 'Aida Hani Kalok', 'role': 'CONTACT', 'email': 'aidahani.mohdkalok@ppukm.ukm.edu.my', 'phone': '+60122024091'}], 'overallOfficials': [{'name': 'Rahana Abd Rahman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}