Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05708820
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2022-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Change from Baseline at 12 months', 'description': 'glycosylated hemoglobin'}], 'secondaryOutcomes': [{'measure': 'Time in Range (TIR)', 'timeFrame': 'Change from Baseline at 12 months', 'description': 'Time spent between 70-180 mg/dl measured by glucose sensor'}, {'measure': 'Knowledge related to diabetes management', 'timeFrame': 'Change from Baseline at 12 months', 'description': 'Diabetes Knowledge Questionnaire (DKQ2)- 15 questions with 4 options, high score indicates maximum level of knowledge'}, {'measure': 'Awareness of hypoglycemia', 'timeFrame': 'Change from Baseline at 12 months', 'description': 'Clarke Test- 8 questions, ≥ 4 answers with R= reduced awareness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type I', 'education programme', 'online'], 'conditions': ['Diabetes Mellitus, Type I']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of an online intervention for people with type 1 diabetes who present not optimal control of the disease.', 'detailedDescription': 'Study area: adults with type 1 diabetes, HbA1c \\>7.5%, \\>3 years diagnosed. Methods: randomized clinical trial. It will include 60 participants . The improvement of Glycated Haemoglobin in both groups before and after intervention will be compared; adherence to the treatment, quality of life, time in the glycaemic range, perception of hypoglycaemia and knowledge about diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HbA1c ≥7,5%\n* More than 3 years of diagnosis\n* Ability to follow online sessions\n* Having a device to follow up the education programme\n\nExclusion Criteria:\n\n* Pregnants\n* People on corticosteroid treatment\n* People with severe disease\n* People with continuous subcutaneous insulin infusion (CSII)'}, 'identificationModule': {'nctId': 'NCT05708820', 'acronym': 'OPTIM@TE', 'briefTitle': 'Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Mutua de Terrassa'}, 'officialTitle': 'Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control', 'orgStudyIdInfo': {'id': 'EO2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Group in face-to-face session', 'interventionNames': ['Behavioral: Standard education programme']}, {'type': 'EXPERIMENTAL', 'label': 'Online education programme', 'description': 'Group in online sessions', 'interventionNames': ['Behavioral: Online education programme']}], 'interventions': [{'name': 'Online education programme', 'type': 'BEHAVIORAL', 'description': 'Online group will follow the education programme through videos that they can view at any time and a live session to answer questions.', 'armGroupLabels': ['Online education programme']}, {'name': 'Standard education programme', 'type': 'BEHAVIORAL', 'description': 'Face-to-face educacion programme in a group session', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Endocrinology Unit', 'role': 'CONTACT'}, {'name': 'Núria Alonso, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Mutua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Núria Alonso-Carril, RN', 'role': 'CONTACT'}, {'name': 'Núria Alonso', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari Mútua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'centralContacts': [{'name': 'Núria Alonso-Carril, RN', 'role': 'CONTACT', 'email': 'nuriaalonso@mutuaterrassa.com', 'phone': '+34 937365050', 'phoneExt': '11330'}], 'overallOfficials': [{'name': 'Núria Alonso, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Mútua Terrassa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Mutua de Terrassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}