protocolSection identificationModule nctId: NCT06308549, orgStudyIdInfo id: 2023.0714, briefTitle: MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY), acronym: MyREMEDY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Maartje de Wit, class: OTHER, collaborators name: Juvenile Diabetes Research Foundation, collaborators name: King's College London, collaborators name: University of Malaga, collaborators name: Forschungsinstitut der Diabetes Akademie Mergentheim, descriptionModule briefSummary: In the MyREMEDY study the investigators research whether the MyDiaMate self-help application is effective in strengthening the mental health of adults with type 1 diabetes in comparison with care as usual. The MyREMEDY study takes place in four countries: The Netherlands, United Kingdom, Spain, and Germany., conditionsModule conditions: Type 1 Diabetes, conditions: Diabetes Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 660, type: ESTIMATED, armsInterventionsModule interventions name: MyDiaMate, outcomesModule primaryOutcomes measure: Diabetes Distress, secondaryOutcomes measure: Emotional well-being, secondaryOutcomes measure: Psychological self-efficacy in relation to diabetes, secondaryOutcomes measure: Social Engagement, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Time in/above/below range, secondaryOutcomes measure: Events of ketoacidosis/severe hypoglycaemia, otherOutcomes measure: MyDiaMate usage data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Forschungsinstitut Diabetes-Akademie Bad Mergentheim, city: Bad Mergentheim, state: Baden-Württemberg, zip: 97980, country: Germany, contacts name: Dominic Ehrmann, role: CONTACT, phone: +4979319613839, email: info@fidam.de, contacts name: Dominc Ehrmann, role: PRINCIPAL_INVESTIGATOR, contacts name: Gina Lehmann, role: SUB_INVESTIGATOR, contacts name: Norbert Hermanns, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.4925, lon: 9.77361, locations facility: Amsterdam UMC, city: Amsterdam, state: Noord-Holland, zip: 1081HV, country: Netherlands, contacts name: Theresa Mohr, MSc, role: CONTACT, phone: +31205669111, email: myremedy@amsterdamumc.nl, contacts name: Maartje de Wit, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Theresa Mohr, MSc., role: SUB_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Universidad de Málaga, city: Málaga, zip: 29071, country: Spain, contacts name: Maria Teresa Anarte, role: CONTACT, phone: +34952131313, email: info@uma.es, contacts name: Maria Teresa Anarte, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.72016, lon: -4.42034, locations facility: King's College London, city: London, zip: WC2R 2LS, country: United Kingdom, contacts name: Kirsty Winkley, Dr., role: CONTACT, phone: +4402078365454, email: MyREMEDY@kcl.ac.uk, contacts name: Kirsty Winkly, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False