protocolSection identificationModule nctId: NCT06374043, orgStudyIdInfo id: 2020/1002, briefTitle: Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin., acronym: @HOME, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-11, primaryCompletionDateStruct date: 2022-09-13, completionDateStruct date: 2022-09-13, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: Randomized placebo-controlled double-blind cross-over N=1 trial in adult male and female patients with UACR \>20 mg/g (2.26 mg/mmol) with type 2 diabetes treated in primary or secondary healthcare.The goal of this clinical trial is to determine the individual response to the SGLT2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR). Secondary objectives are to determine the individual response to dapagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose.Participants will collect all study data in the comfort of their own environments:* First-morning void urine samples* Capillary blood samples* Blood pressure* Body weightParticipants will be randomly assigned to a cross-over study consisting of two periods of 1-week treatment with dapagliflozin 10 mg/day and two periods of 1-week treatment with placebo in random order with a 1-week wash-out period between every treatment period to avoid cross-over effects., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Diabetes Mellitus Type 2 With Proteinuria, conditions: Diabetes Mellitus, conditions: Diabetes, conditions: Diabetes Complications, conditions: Albuminuria, conditions: Chronic Kidney Diseases, conditions: Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, conditions: CKD, conditions: Proteinuria, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized placebo-controlled double-blind cross-over trial with repeated administration (i.e., a series of N=1 trials)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Dapagliflozin 10mg Tab, interventions name: Placebo, interventions name: Withings BPM Connect, interventions name: Withings Body+, interventions name: Hem-Col Capillary Blood Collection Device, interventions name: MEMS (Medication Electronic Monitoring System) Cap, interventions name: Questionnaire: participants' perspectives toward remote data collection, outcomesModule primaryOutcomes measure: UACR response, secondaryOutcomes measure: Systolic blood pressure response, secondaryOutcomes measure: Body weight response, secondaryOutcomes measure: eGFR response, secondaryOutcomes measure: Fasting plasma glucose response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ziekenhuisgroep Twente, city: Almelo, country: Netherlands, geoPoint lat: 52.35667, lon: 6.6625, locations facility: University Medical Center Groningen, city: Groningen, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False