Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-06 @ 8:00 AM
Study NCT ID:
NCT05521893
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Telemedicine Care Replacing Standard Care 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-25', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-08-25', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average fasting glucose concentration', 'timeFrame': '1 month', 'description': "Average fasting based on participant's SMBG in the 3rd trimester"}, {'measure': 'Percentage of glucose readings in the target range', 'timeFrame': '1 month', 'description': 'average percentage for the 3rd trimester'}, {'measure': 'Compliance with SMBG', 'timeFrame': '1 month', 'description': 'is defined as defined as the number of actual glucose measurements performed divided by the number of recommended glucose measurements\\*100'}, {'measure': 'The percentage of individuals needing insulin treatment', 'timeFrame': 'once during pregnancy'}, {'measure': 'Average postprandial glucose concentration', 'timeFrame': '1 month', 'description': "Average postprandial glucose based on participant's SMBG in the 3rd trimester"}], 'secondaryOutcomes': [{'measure': 'gestational weight gain', 'timeFrame': 'once during pregnancy', 'description': 'from pre-conception until labour'}, {'measure': 'Newborn birth weight', 'timeFrame': 'delivery'}, {'measure': 'LGA incidence', 'timeFrame': 'delivery'}, {'measure': 'Gestational age at birth', 'timeFrame': 'delivery'}, {'measure': 'Preterm birth', 'timeFrame': 'delivery'}, {'measure': 'Incidence of preeclampsia', 'timeFrame': 'delivery'}, {'measure': 'Incidence of caesarean section', 'timeFrame': 'delivery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['telemedicine', 'glycemic control', 'perinatal outcomes'], 'conditions': ['Gestational Diabetes']}, 'referencesModule': {'references': [{'pmid': '37185903', 'type': 'DERIVED', 'citation': 'Munda A, Mlinaric Z, Jakin PA, Lunder M, Pongrac Barlovic D. Effectiveness of a comprehensive telemedicine intervention replacing standard care in gestational diabetes: a randomized controlled trial. Acta Diabetol. 2023 Aug;60(8):1037-1044. doi: 10.1007/s00592-023-02099-8. Epub 2023 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'This is a a single-centre, parallel, randomized controlled trial in women with gestational diabetes mellitus (GDM). Women are randomized to routine monthly prenatal clinic care (standard care group) or a group sending daily glucose readings via an application installed on a smartphone and monthly individual videoconferences replacing in-person visits (telemedicine group). The overall aim is to compare the effectiveness of the combine synchronous and asynchronous telemedicine care with the standard care in women with GDM.', 'detailedDescription': "In our single-centre, parallel, randomized controlled trial in women with gestational diabetes (GDM) the investigators aim to compare the effectiveness of combined synchonous and asynchronous telemedicine care with the standard care.\n\nIn the telemedicine group appointments are performed online via monthly scheduled videoconferences. Women also receive a smartphone with the installed application that enable transfer of the measured capillary glucose concetration at the same time it is performed. The glucose data sent by women are reviewed once per week and after that healthcare professionals contact women if necessary. On the other hand, in the standard care group, visits are scheduled normally on a monthly basis at the diabetes clinic.\n\nIntention-to-treat analysis is going to be performed. The investigators aim to compare glycemic control, gestational weight gain and perinatal data between groups.\n\nStudent's t-test or Mann-Whitney U test will be used for normally or non-normally distributed variables. Differences between groups in categorical data will be calcuated by Chi square."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* less then 30 weeks of gestation at enrolement\n* GDM diagnosis\n* at least moderate Slovenian language skills\n* willingness to participate\n\nExclusion Criteria:\n\n* more than 30 weeks of pregnancy\n* overt diabetes or fasting glucose \\>6.9 mmol/l at diagnosis\n* multiple pregnancy\n* poor Slovene language skills\n* history or bariatric surgery or other surgeries that induce malabsorbtion\n* use of systemic steroids prior to enrolment\n* presence of concomitant disease that could affect glucose control or self-management (e.g. uncontrolled psychiatric disorder)'}, 'identificationModule': {'nctId': 'NCT05521893', 'briefTitle': 'Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0120-302/2020-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemedicine group', 'interventionNames': ['Other: Telemedicine care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care group', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Telemedicine care', 'type': 'OTHER', 'description': 'In the telemedicine group, the appointments are performed online via scheduled videoconferences, on a monthly basis.\n\nAll women in the telemedicine group receive a smartphone with the installed application that enable transfer of the measured capillary glucose concentration.', 'armGroupLabels': ['Telemedicine group']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'In the standard care group, visits are scheduled at the diabetes clinic on a monthly basis.', 'armGroupLabels': ['Standard care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Drazenka Pongrac Barlovic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}