Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT02783612
Status:
UNKNOWN
Last Update Posted:
2016-05-26
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Glucose Monitoring 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2016-04-12', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the compliance of the research group compared to the control group.', 'timeFrame': '18 month', 'description': 'By calculating the amount of daily glucose measurements in the research group compared to the number of glucose measurements in the control group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'Assessing blood glucose control in women with gestational diabetes can be challenging. The standard of care remains visual inspection of blood glucose paper diaries of self-performed capillary monitoring during regular meeting in High Risk pregnancy clinics.\n\nThe researchers are interested in preforming a randomized control trial comparing women with the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital monitoring using an application in a Smart-phone and submitting those values via email in addition to the regular clinic appointments.\n\nThe Primary outcome of the trial is to assess the compliance of the research group as compared to the control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational diabetes\n\nExclusion Criteria:\n\n* pre-gestational diabetes'}, 'identificationModule': {'nctId': 'NCT02783612', 'briefTitle': 'Digital Glucose Monitoring in Gestational Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Improvement of Compliance by Digital Blood Glucose Monitoring of Women With Gestational Diabetes', 'orgStudyIdInfo': {'id': 'GDMAPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glucose application', 'description': 'Regular high risk pregnancy clinic surveillance in addition to a Smart phone application for registering the Blood glucose levels and submitting via email every 3-5 days to the High risk Doctor involved in the trial.', 'interventionNames': ['Other: glucose buddy application']}, {'type': 'NO_INTERVENTION', 'label': 'Regular monitoring', 'description': 'Regular high risk pregnancy clinic surveillance'}], 'interventions': [{'name': 'glucose buddy application', 'type': 'OTHER', 'armGroupLabels': ['glucose application']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hadas Miremberg, MD', 'role': 'CONTACT', 'email': 'dasile2@gmail.com', 'phone': '972526741740'}], 'facility': 'Wolfson medical center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'centralContacts': [{'name': 'Hadas Miremberg, MD', 'role': 'CONTACT', 'email': 'dasile2@gmail.com', 'phone': '972526741740'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}