Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-30 @ 9:10 PM
Study NCT ID:
NCT03819335
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2019-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-18', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Empowerment', 'timeFrame': 'Baseline visit and month 12', 'description': 'Change from baseline score in the Diabetes Empowerment Scale-Short Form Spanish version (DES-SF-S) (8, worse to 40, better) at 12 months'}], 'secondaryOutcomes': [{'measure': 'Adherence to glycemic monitoring', 'timeFrame': 'Baseline visit and month 3, 6, 9 and 12', 'description': 'Change from baseline frequency of glycemic monitoring (number of capillary blood glucose tests per day) at each follow-up visit'}, {'measure': 'Adherence to recommendations', 'timeFrame': 'Each follow-up visit (month 3, 6, 9 and 12)', 'description': 'Percentage of recommendations given by the medical team followed'}, {'measure': 'Adherence to visits', 'timeFrame': 'Each follow-up visit (month 3, 6, 9 and 12)', 'description': 'Percentage of face-to-face visits and telematic visits attended'}, {'measure': 'Adherence to the app', 'timeFrame': 'End of the study (month 12) and 3 months after', 'description': 'Percentage of patients who continue using the app after the end of the study'}, {'measure': 'Daily management of diabetes', 'timeFrame': 'Baseline visit and month 12', 'description': 'Change from baseline score in the questionnaire that evaluates the number of tasks performed in relation to diabetes (ad hoc) at 12 months'}, {'measure': 'Quality of life related to diabetes', 'timeFrame': 'Baseline visit and month 12', 'description': 'Change from baseline score in the Spanish version of the Diabetes Quality Of Life questionnaire (EsDQOL) (satisfaction: 75, worse, to 15, better; impact: 85, worse, to 17, better; social and vocational concern: 45, worse, to 7, better; concern related to diabetes: 20, worse, to 4, better) at 12 months'}, {'measure': 'Self-efficacy', 'timeFrame': 'Baseline visit and month 12', 'description': 'Change from baseline score in the Diabetes Distress Scale Spanish version (DSS-S) (102, worse, to 17, better) at 12 months'}, {'measure': 'Glycemic control', 'timeFrame': 'Baseline visit and month 3, 6, 9 and 12', 'description': 'Change from baseline mean blood glucose (mg/dl), standard deviation, low and high blood glucose index at each follow-up visit'}, {'measure': 'Glycemic control', 'timeFrame': 'Baseline visit and month 6 and 12', 'description': 'Change from baseline HbA1c DCA (%) at 6 and 12 months'}, {'measure': 'Satisfaction with the app', 'timeFrame': 'End of the study (month 12)', 'description': 'Score in the satisfaction questionnaire in relation to the use of the platform (ad hoc)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 1', 'Mobile Applications', 'Telemedicine'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '39412732', 'type': 'DERIVED', 'citation': 'Cuixart G, Corcoy R, Gonzalez C. Can a mobile application improve glucose-related and patient-reported outcome measures (PROMs) in people with type 1 diabetes mellitus? A randomized controlled trial using the mySugr(R) app. Hormones (Athens). 2025 Mar;24(1):137-147. doi: 10.1007/s42000-024-00609-z. Epub 2024 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'This project is based on the contribution that an app can offer for improving knowledge and self-management of people with type 1 diabetes.\n\nThe main objective of this study is to assess mySugr app as a tool for empowering people with type 1 diabetes.\n\nThe study population are type 1 diabetes people, aged more than 18 years old and with more than one year from diagnosis. They will be randomised to standard care or use of mySugr app and will be followed-up during 48 weeks.\n\nControl group will attend 5 face-to-face visits (baseline, 3, 6, 9 and 12 months) with the possibility of telephone contact and hospital assistance if necessary. Intervention group will attend 3 face-to-face visits (baseline, 6 and 12 months) and 2 telematic visits (at 3 and 9 months) and will also have the possibility of telephone contact and hospital assistance if necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* People with type 1 diabetes (\\> 1 year diagnosis)\n* Treatment with insulin in basal-bolus regimen\n* Glucometer that connects automatically with the app\n* HbA1c 7-9%\n* Understanding of carbohydrate counting and concepts of ratio and factor of sensitivity\n* Have a smartphone or tablet\n\nExclusion Criteria:\n\n* Use at the time of randomization of another app for diabetes management\n* Use of continuous monitoring or flash glucose systems\n* Pregnancy\n* Any other disease or condition that may interfere with the completion of the protocol or completion of the study'}, 'identificationModule': {'nctId': 'NCT03819335', 'briefTitle': '¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': '¿Puede Una aplicación móvil Mejorar el Conocimiento y la autogestión de Las Personas Con Diabetes Tipo 1? Evaluación clínica de la App mySugr', 'orgStudyIdInfo': {'id': 'IIBSP-SUG-2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Usual follow-up of diabetes type 1 with face-to-face visits', 'interventionNames': ['Other: Standard care']}, {'type': 'EXPERIMENTAL', 'label': 'mySugr app', 'description': 'Telemedical assistance with mySugr app', 'interventionNames': ['Device: mySugr app']}], 'interventions': [{'name': 'mySugr app', 'type': 'DEVICE', 'description': 'mySugr is a mobile medical app for diabetes management. It has been developed by Roche Diabetes Care and it has two versions, free and Pro. It allows to carry out the diary of diabetes, including the collection and analysis of data on glycaemia, food, physical activity or insulin dose. In addition, it is compatible with continuous glucose measurement systems. It has the possibility to add functionalities such as estimation of HbA1c levels, more detailed data analysis or integration with Google Fit type motion sensors, as well as a bolus calculator, reminders for measuring blood glucose or photo gallery in the Pro version, which is the one that will be provided to the patients for the study.', 'armGroupLabels': ['mySugr app']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Face-to-face visits', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Diagnostics GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}