Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05977218
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dietary effects on proteomics and metabolomics', 'timeFrame': 'Change from baseline at week 26', 'description': 'Dietary effects on proteomics and metabolomics'}], 'primaryOutcomes': [{'measure': 'Mean HbA1c', 'timeFrame': 'Change from baseline at week 26', 'description': 'Mean glycated haemoglobin'}], 'secondaryOutcomes': [{'measure': 'Self-measured waist circumference (cm)', 'timeFrame': 'Change from baseline at week 26', 'description': 'Self-measured waist circumference (cm)'}, {'measure': 'Self-reported quality of life', 'timeFrame': 'Change from baseline at week 26', 'description': 'Self-reported quality of life - questionnaire'}, {'measure': 'Self-measured body weight (kg)', 'timeFrame': 'Change from baseline at week 26', 'description': 'Self-measured body weight (kg)'}, {'measure': 'Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications', 'timeFrame': 'Change from baseline at week 26', 'description': 'Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications'}, {'measure': 'Self-reported dietary self-efficacy', 'timeFrame': 'Change from baseline at week 26', 'description': 'Self-reported dietary self-efficacy'}, {'measure': 'Difference in all-cause mortality', 'timeFrame': 'Change from baseline at week 26', 'description': 'Difference in all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet', 'Mobile health', 'HbA1c'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '41248424', 'type': 'DERIVED', 'citation': 'Af Geijerstam P, Johansson E, Fagerstam S, Wu JH, Ghafouri B, Karlsson K, Hebib L, Kastbom L, Wennberg P, Gustafson Hedov E, Storgards M, Sundstrom J, Radholm K. Effect of the FoodSwitch application on type 2 diabetes in Sweden: a study protocol for the randomised controlled DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients trial (DIATEST-HELP). BMJ Open. 2025 Nov 16;15(11):e110141. doi: 10.1136/bmjopen-2025-110141.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will assess the impact of the FoodSwitch mobile app, which provides interpretive front-of-pack labelling via barcode scanning, in 900 Swedish adults with type 2 diabetes. Participants will be randomized to app + standard advice or standard advice alone. The primary outcome is change in HbA1c at 6 months; secondary outcomes include anthropometrics, quality of life, medication use, hospitalizations, and mortality.', 'detailedDescription': 'A healthy diet improves glycaemic control and reduces cardiovascular risk in type 2 diabetes (T2D), but access to dietitians is limited. Unlike several countries, Sweden has not implemented interpretive front-of-pack labelling. Smartphone applications may offer an alternative. This trial evaluates the dietary and clinical impact of FoodSwitch, a mobile app providing interpretive labelling to Swedish adults with T2D. Nine hundred individuals with T2D for ≥2 years who regularly shop for groceries will be recruited via general practices and community advertisements and randomized to receive access to FoodSwitch plus standard written dietary advice, or standard written dietary advice only. The primary outcome is change in self-measured glycated haemoglobin (HbA1c) after 6 months. Secondary outcomes include waist circumference, body weight, quality of life, dietary self-efficacy, medication use, hospitalizations, and all-cause mortality. Exploratory outcomes include omics analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age between 18 and 75 years\n* Self-reported type 2 diabetes with a duration of ≥2 years\n* Regularly grocery shopping\n\nExclusion criteria:\n\n* No access to BankID (a digital identification system commonly used in Sweden)\n* Failure to complete eligibility screening and run-in periods'}, 'identificationModule': {'nctId': 'NCT05977218', 'acronym': 'DIATEST-HELP', 'briefTitle': 'DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial', 'orgStudyIdInfo': {'id': 'DIATEST-HELP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Access to the 'DiabetesSwitch' filter of the FoodSwitch app when grocery shopping during 26 weeks, in addition to standard written dietary advice", 'interventionNames': ['Other: FoodSwitch']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Access to standard written dietary advice'}], 'interventions': [{'name': 'FoodSwitch', 'type': 'OTHER', 'description': "Access to the 'DiabetesSwitch' filter of the FoodSwitch app when grocery shopping. When a packaged food item bar code is scanned, the FoodSwitch app will show an interpretive nutritional information score for the scanned product and recommend alternate healthier food options in the same category.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Siri Fägerstam', 'role': 'CONTACT', 'email': 'diatest-help@liu.se', 'phone': '+46-(0)13-281661'}], 'facility': 'Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'centralContacts': [{'name': 'Lana Hebib, MD', 'role': 'CONTACT', 'email': 'lana.hebib@liu.se', 'phone': '013-28 10 00'}], 'overallOfficials': [{'name': 'Karin Rådholm, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Linkoeping University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.', 'ipdSharing': 'YES', 'accessCriteria': 'To be determined on a case by case basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Lana Hebib', 'investigatorAffiliation': 'Linkoeping University'}}}}