Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-01 @ 8:26 AM
Study NCT ID:
NCT04007003
Status:
TERMINATED
Last Update Posted:
2019-12-03
First Post:
2019-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-02', 'studyFirstSubmitDate': '2019-06-06', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Use', 'timeFrame': 'up to 6 months', 'description': 'Change in Total Daily Dose of insulin for subjects at baseline and after 6 months; expressed as % and units/24 hrs'}], 'secondaryOutcomes': [{'measure': 'Change in Glycemic Control', 'timeFrame': 'up to 6 months', 'description': 'Change in HbA1c for subjects at baseline and after 6 months; expressed as % and mmol/mol'}, {'measure': 'Incidence of Hypoglycemic Events', 'timeFrame': 'up to 6 months', 'description': 'Rate of hypoglycemic events requiring 3rd party assistance in 6 months prior to study start (baseline) and during the 6 months of the study'}, {'measure': 'Change in Needle Re-Use', 'timeFrame': 'up to 6 months', 'description': 'Rate of needle re-use by self-reporting at baseline and after 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': "The study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. The optimal injection technique is delivered through education via a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform .\n\nThe study is conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points will include the impact on use of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 Diabetes Mellitus, or Type 2 Diabetes Mellitus\n* Injecting insulin for at least 1 year\n* Self-managing injection therapy, including daily glucose monitoring\n* Access to a device with internet\n* Confident in navigating the internet\n\nExclusion Criteria:\n\n* Pregnant or likely to become pregnant during study period\n* Impaired cognitive ability which would prevent informed consent\n* Syringe only user\n* Insulin pump user\n* Glucagon-Like Peptide (GLP)-1 receptor agonists therapy only'}, 'identificationModule': {'nctId': 'NCT04007003', 'briefTitle': 'An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform', 'organization': {'class': 'INDUSTRY', 'fullName': 'Becton, Dickinson and Company'}, 'officialTitle': 'An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform', 'orgStudyIdInfo': {'id': 'LiMo Audit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'optimal injection technique', 'description': 'Subjects will be trained on site regarding optimal insulin injection technique, including avoiding injections in lipohypertrophy areas and proper rotation. Furthermore subjects are provided with access codes to watch online training modules on the Becton Dickinson (BD) and Me(TM) platform', 'interventionNames': ['Behavioral: training in optimal insulin injection technique']}], 'interventions': [{'name': 'training in optimal insulin injection technique', 'type': 'BEHAVIORAL', 'description': 'the training will be delivered in person as well as through online training modules via the BD and Me(TM) platform', 'armGroupLabels': ['optimal injection technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imeldaziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Virga Jesse Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Sint-Niklaas', 'country': 'Belgium', 'facility': 'AZ Nikolaas', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'city': 'Turnhout', 'country': 'Belgium', 'facility': 'AZ Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}, {'city': 'Vilvoorde', 'country': 'Belgium', 'facility': 'AZ Jan Portaels', 'geoPoint': {'lat': 50.92814, 'lon': 4.42938}}], 'overallOfficials': [{'name': 'Christophe De Block, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Becton, Dickinson and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}