protocolSection identificationModule nctId: NCT06290544, orgStudyIdInfo id: CCM 1552, briefTitle: Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1), acronym: CARDT1, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-29, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Centro Cardiologico Monzino, class: OTHER, descriptionModule briefSummary: This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Standard of care plus additional examinations, outcomesModule primaryOutcomes measure: Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines., primaryOutcomes measure: Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE)., primaryOutcomes measure: Prevalence of cardiovascular disease in type 1 diabetes patients, secondaryOutcomes measure: Prevalence of diabetic retinopathy, secondaryOutcomes measure: Prevalence of diabetic nephropathy, secondaryOutcomes measure: Prevalence of diabetic neuropathy, secondaryOutcomes measure: CT-derived calcium score, secondaryOutcomes measure: Carotid intima-media thickness, secondaryOutcomes measure: Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method), secondaryOutcomes measure: Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ), secondaryOutcomes measure: Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS), secondaryOutcomes measure: Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires., secondaryOutcomes measure: Stratify type 1 patient cohort by lipid profile, secondaryOutcomes measure: Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Centro Cardiologico Monzino, status: RECRUITING, city: Milan, zip: 20138, country: Italy, contacts name: Stefano Genovese, MD, role: CONTACT, phone: 0258002327, email: stefano.genovese@cardiologicomonzino.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlinico di Monza, status: NOT_YET_RECRUITING, city: Monza, zip: 20900, country: Italy, contacts name: Gianluca Perseghin, MD, role: CONTACT, phone: +390392810430, email: gianluca.perseghin@policlinicodimonza.it, geoPoint lat: 45.58005, lon: 9.27246, hasResults: False