[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615304":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":49,"collaborators":51,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":83,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Fundacion Miguel Servet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diactive-1","EXPERIMENTAL","The intervention in the experimental group will center around the use of a mobile application (i.e., device), namely the Diactive-1 app.",[13],"Device: Diactive-1",{"label":15,"type":16,"description":17,"interventionNames":18},"Waiting-list control group","NO_INTERVENTION","This arm will not complete an intervention. Participants will be instructed to continue to follow their normal daily diabetes care plan (i.e., standard care). This group will be granted access to the app following the intervention.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","Participants will engage in a 12-week resistance exercise program with the goal of maintaining at least 3 sessions per week, with 3-6 exercises per session (≈13-33 minutes). Participants will be able to choose among three training formats, traditional resistance training, Tabata\u002Fhigh-intensity intervals, or circuit training, and may perform the sessions individually or in pairs, depending on preference and feasibility at the center. The training intervention will comprise 3-4 sets of 6-12 repetitions and will consist of a combination of exercises for the upper body, lower body, and core, using primarily the participants' own body weight. The load and intensity of the exercise will be adjusted according to the number of repetitions and the difficulty\u002Fprogression of the selected exercises. A mobile application (Diactive-1) will be used to deliver, monitor, and record the sessions.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Antonio García Hermoso, PhD","CONTACT","+34948 166194","antonio.garciah@unavarra.es",[31],{"facility":32,"status":18,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Fundación Miguel Servet\u002F Navarrabiomed","Pamplona","Navarre","31008","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],-1.64323,42.81687,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":47,"phoneExt":18,"email":48},"Ruth García Rey","+(34) 848 42 21 63","ruth.garcia.rey@navarra.es",{"type":50,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[52,54,56],{"name":53,"class":6},"Universidad Pública de Navarra",{"name":55,"class":6},"University of Valencia",{"name":57,"class":6},"Fundación Instituto de Investigación Sanitaria de Navarra","100615304","diactive-1-scaled-up-personalized-mhealth-program-for-youth-with-type-1-diabetes-100615304",false,"NCT07290868","Diactive-1: Scaled-up Personalized mHealth Program for Youth With Type 1 Diabetes","Scaling up Personalized mHealth-supported Resistance Training and Education for Children and Adolescents With Type 1 Diabetes: The Diactive-1 v2.0 Randomized Controlled Trial","Diactive-1v2","Inclusion Criteria:\n\n* Diagnosed with Type 1 Diabetes Mellitus (T1DM) for 6 months or longer (requiring \\>0.5 U\u002Fkg\u002Fday of insulin and having HbA1c \\>6%, i.e., not in the \"honeymoon phase\").\n* Receiving multiple daily injection (MDI) therapy or insulin pump therapy (CSII).\n* Signed informed consent authorizing legal participation in the research project (child\u002Fadolescent and parent(s)\u002Flegal guardian).\n* Availability to participate in the study using an m-Health application (Diactive-1) designed for the programming of muscle-bone strengthening physical exercise.\n* Understanding of Spanish.\n\nExclusion Criteria:\n\n* Comorbidities that limit the ability to engage in physical activity.\n* Lack of internet access when using the application, whether due to Wi-Fi, mobile data, or international roaming issues.\n* Absence of a mobile phone or tablet with an Android or iOS (Apple) operating system, or no family member willing to lend a device for each session using the application for study-related purposes.","ALL","10 Years","18 Years",{"count":70,"type":71},158,"ESTIMATED","INTERVENTIONAL",[74],"NA","The Diactive-1 project aims to establish the Diactive-1 mobile application as a clinical tool for managing type 1 diabetes in children and adolescents in several hospitals from Spain. The successful implementation of the app in new healthcare centers nationwide represents a key step toward the development of a comprehensive and scalable program. This approach seeks not only to optimize current patient care but also to democratize access to an innovative, evidence-based intervention that supports daily diabetes management.\n\nIn this new phase, the project will integrate the application into routine clinical care for patients with type 1 diabetes through the use of a simple handgrip strength measurement. A dedicated web platform (www.diactive.es) is being developed to allow clinicians to enter basic patient data, including handgrip strength, sex, and email address. Based on this information, the system will automatically generate a personalized download link for the Diactive-1 app, accompanied by tailored guidance and an initial fitness level classification (low, medium, or high) according to European reference values.\n\nThis process will define each user's baseline fitness level and facilitate the use of Diactive-1 as an integrated and individualized disease management tool. The ultimate goal is to strengthen clinical decision-making, improve patient engagement, and extend the benefits of digital health to a broader pediatric population living with type 1 diabetes.",[77],"Type 1 Diabetes (T1D)",[79,80,81,82],"mHealth","Resistance training","Education","Handgrip strength","NOT_YET_RECRUITING","2025-12-17",{"date":86,"type":87},"2025-12-18","ACTUAL",{"date":89,"type":71},"2026-01",{"date":91,"type":71},"2027-03",{"name":5,"class":6},1]