[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604445":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":199,"collaborators":18,"id":201,"slug":18,"hasResults":202,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":202,"sex":208,"minAge":209,"maxAge":18,"enrollmentInfo":210,"targetDuration":18,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"Marche Region Regional Health Agency","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treated group (utilizing m-health solution)","ACTIVE_COMPARATOR","The participants assigned to the treated group, in addition to the regular T2DM care, will be provided with a m-health solution to support the SM of T2DM, aimed to improve their SM' skills and abilities. The m-health solution will allow the patients to:\n\n1. track their data, such as glycaemic status, blood pressure, therapy, steps and physical activity, sleep, body weight, laboratory tests (HbA1c, creatinine, cholesterol, etc.);\n2. check the target values defined by the diabetologist (e.g., blood glucose, HbA1c, lipid profile, etc.);\n3. view their treatment plan;\n4. view the diet indicated by the dietitian and record meals\u002Fcalculate calories\u002Fcarbohydrates in a simple way (e.g., through list of foods with pictures of dishes and portions);\n\n3\\) receive alerts (e.g., therapy reminders) and motivational messages; 4) view summary statistics; 5) communicate with the HCPs through a chat; 6) fill out surveys; 7) access to educational material and technical assistance;",[13],"Device: M-health solution classified as Class I Medical Devices, equipped with a CE certificate. The m-health solution will be integrated with the EPR currently used by the CADs of the Marche region",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group (attending usual T2DM care)","NO_INTERVENTION","The patients assigned to the control group will receive regular T2DM care according to the Diabetes Association standards",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","M-health solution classified as Class I Medical Devices, equipped with a CE certificate. The m-health solution will be integrated with the EPR currently used by the CADs of the Marche region","The m-health solution used in the study includes the following interfaces:\n\n1. for the HCPs of the CADs:\n\n   * a section of the EPR currently used (Metaclinic), to set the mobile application and to collect clinical data recorded by the patients;\n   * a software to develop and monitor personalised diets (MetaDieta);\n2. for the patients: two mobile applications, one for the monitoring of the clinical data and life style (DiaWatch Meteda) and one for the monitoring of the diet (MyDiet), with the latter accessible from a 'button' included in the first one.\n\nThe HCPs of the CADs, already having access to the EPR Metaclinic, will access a dedicated section for the setting of the target values and goals (e.g., glycaemia, physical activity, etc.) and for the activation of the app DiaWatch Meteda. After the connection of the app with Metaclinic, the data registered in the apps by the patients will be visible by the HCPs in the EPR dashboard.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Project Manager","CONTACT","+39 071. 8064137","roberta.papa@regione.marche.it",[32,49,59,73,85,97,110,121,134,148,160,174,187],{"facility":33,"status":34,"city":35,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Diabetic Center of Azienda Ospedaliero Universitaria delle Marche","RECRUITING","Ancona","60126","Italy",{"type":39,"coordinates":40},"Point",[41,42],13.5103,43.60717,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":47,"phoneExt":18,"email":48},"Diabetologist","+39 071 5964754","massimiliano.petrelli@ospedaliriuniti.marche.it",{"facility":50,"status":34,"city":35,"state":35,"zip":51,"country":37,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Diabetic Center of National Institute for the Care and Treatment of the Elderly (Istituto Nazionale di Ricovero e Cura per Anziani-INRCA)","60127",{"type":39,"coordinates":53},[41,42],{"lat":42,"lon":41},[56],{"name":46,"role":28,"phone":57,"phoneExt":18,"email":58},"+39 071.8003551","e.tortato@inrca.it",{"facility":60,"status":61,"city":62,"state":35,"zip":63,"country":37,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Diabetic Center of Territorial Healthcare Authority of Ancona province","NOT_YET_RECRUITING","Fabriano","60044",{"type":39,"coordinates":65},[66,67],12.90327,43.33941,{"lat":67,"lon":66},[70],{"name":46,"role":28,"phone":71,"phoneExt":18,"email":72},"+39 0732-707746","vanessa.ronconi@sanita.marche.it",{"facility":60,"status":34,"city":74,"state":35,"zip":75,"country":37,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Iesi","60035",{"type":39,"coordinates":77},[78,79],13.24368,43.52142,{"lat":79,"lon":78},[82],{"name":46,"role":28,"phone":83,"phoneExt":18,"email":84},"0731.534223","paola.canibus@sanita.marche.it",{"facility":60,"status":61,"city":86,"state":35,"zip":87,"country":37,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Senigallia","60019",{"type":39,"coordinates":89},[90,91],13.20882,43.71626,{"lat":91,"lon":90},[94],{"name":46,"role":28,"phone":95,"phoneExt":18,"email":96},"+39 071-79092470","silvia.rilli@sanita.marche.it",{"facility":98,"status":61,"city":99,"state":99,"zip":100,"country":37,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province","Ascoli Piceno","63100",{"type":39,"coordinates":102},[103,104],13.57395,42.85351,{"lat":104,"lon":103},[107],{"name":46,"role":28,"phone":108,"phoneExt":18,"email":109},"0736.358272","marianna.galetta@sanita.marche.it",{"facility":98,"status":34,"city":111,"state":99,"zip":112,"country":37,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"San Benedetto del Tronto","63074",{"type":39,"coordinates":114},[115,116],13.87676,42.9568,{"lat":116,"lon":115},[119],{"name":46,"role":28,"phone":120,"phoneExt":18,"email":109},"‭0735 793315‬",{"facility":122,"status":34,"city":123,"state":123,"zip":124,"country":37,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Diabetic Center of Territorial Healthcare Authority of Fermo province","Fermo","63900",{"type":39,"coordinates":126},[127,128],13.72274,43.16296,{"lat":128,"lon":127},[131],{"name":46,"role":28,"phone":132,"phoneExt":18,"email":133},"0734.6252554","paola.pantanetti@sanita.marche.it",{"facility":135,"status":34,"city":136,"state":137,"zip":138,"country":37,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Diabetic Center of Territorial Healthcare Authority of Macerata province","Civitanova Marche","Macerata","62012",{"type":39,"coordinates":140},[141,142],13.72068,43.30491,{"lat":142,"lon":141},[145],{"name":46,"role":28,"phone":146,"phoneExt":18,"email":147},"+39 0733.823079","cristian.quattrini@sanita.marche.it",{"facility":135,"status":34,"city":149,"state":137,"zip":150,"country":37,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Province of Macerata","62100",{"type":39,"coordinates":152},[153,154],13.45293,43.29789,{"lat":154,"lon":153},[157],{"name":46,"role":28,"phone":158,"phoneExt":18,"email":159},"+39 0733. 2572493","gabriele.brandoni1@sanita.marche.it",{"facility":161,"status":34,"city":162,"state":163,"zip":164,"country":37,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province","Fano","Pesaro-Urbino","61032",{"type":39,"coordinates":166},[167,168],13.01665,43.84052,{"lat":168,"lon":167},[171],{"name":46,"role":28,"phone":172,"phoneExt":18,"email":173},"0721.882354","gabriella.garrapa@sanita.marche.it",{"facility":161,"status":34,"city":175,"state":176,"zip":177,"country":37,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Pesaro","Pesaro-urbino","61122",{"type":39,"coordinates":179},[180,181],12.9164,43.90921,{"lat":181,"lon":180},[184],{"name":46,"role":28,"phone":185,"phoneExt":18,"email":186},"0721.362443","giulio.lucarelli@sanita.marche.it",{"facility":161,"status":61,"city":188,"state":163,"zip":189,"country":37,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Urbino","61029",{"type":39,"coordinates":191},[192,193],12.63633,43.72621,{"lat":193,"lon":192},[196],{"name":46,"role":28,"phone":197,"phoneExt":18,"email":198},"0722.301279","maurizio.sudano@sanita.marche.it",{"type":200,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100604445",false,"NCT07149610","Connected Care for Type 2 Diabetes Self-Management","Connected Care for Type 2 Diabetes: a Study Protocol for a Structured Self-Management Intervention Through Technology and Healthcare Collaboration","RCT_SM","Inclusion Criteria:\n\n* patients with T2DM (as confirmed by the physician's diagnosis);\n* belonging to one of the 13 Diabetes Centres (CADs) of the Marche region in Italy (Pesaro, Urbino, Fano, Senigallia, Jesi, Fabriano, IRCCS-INRCA, Azienda Ospedaliera Universitaria delle Marche, Civitanova Marche, Macerata, Fermo, San Benedetto del Tronto e Ascoli Piceno);\n* age \\> = 18;\n* resident in the Marche region;\n* HbA1c \\> 7 on most recent laboratory report within the last 3 months;\n* no changes in diabetes medication in the previous 6 months;\n* no prescription for any hypoglycaemic agent within the previous 4 weeks or taking a consistent dose of one or more oral hypoglycaemic agents for more than 12 weeks;\n* owning smartphone\u002Fmobile phone with an internet connection;\n* capable to consent;\n* fulfilling and signing the informed consent;\n* with self-reported competencies of communicating verbally in local language (corresponding to a level of Italian language knowledge =\\>A2 of the CEFR levels).\n\nExclusion Criteria:\n\n* acute medical problems: myocardial infarction or stroke within 6 months, difficulty in exercise and physical activity due to spinal disease (intervertebral disc prolapse, spinal stenosis, etc.), joint disease, or major surgery at the time of screening, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and\u002For neuromuscular disorders, advanced dementia, metastatic cancer, in long-term immunosuppressant therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study, severe\u002Fmajor depression and other relevant psychiatric disorders;\n* estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2;\n* plan to receive surgery that could limit physical activity during the study period;\n* pregnant or breastfeeding;\n* participation in another studies;\n* lack of written informed consent.","ALL","18 Years",{"count":211,"type":212},388,"ESTIMATED","INTERVENTIONAL",[215],"NA","The primary objective of this Randomized Clinical Trial is to improve the self-management (SM) competencies of patients affected by Type 2 Diabetes Mellitus (T2DM) living in the Marche region (Italy) through the support of a mobile health (m-health) solution personalised by the diabetologist and integrated with the Electronic Patient Record (EPR), assessed through the change in glycated haemoglobin (HbA1c) levels (%) from baseline to the end of the intervention (primary outcome).\n\nResearchers will compare the use of the m-health solution (treated group) to usual T2DM care (control group) in determining change in HbA1c levels (%). The intervention will start at the Diabetic Centres (CADs) where patients are currently followed up and will then take place in each participant's home\n\nParticipants of the treated group will:\n\n* receive dedicated training on the use of the m-health solution\n* receive the personalization of the m-health solution\n* use the m-health solution to: 1) track and view the data related to their health status (e.g., glycaemic status, lifestyle habits, diet) and treatment plane; 2) receive alerts and motivational messages; communicate with the Health Care Professionals (HCPs) of the Diabetic Centre (CAD) in case of need; 3) access to the educational material and to the technical assistance, when needed.\n\nHCPs will be able to monitor the patients' data and clinical parameters and to communicate with the patients. After a baseline evaluation (T0), three follow-up evaluations will be conducted at 6, 12 and 18 months (T1-T2-T3 respectively) , during the usual physician' visits, as part of clinical routine.\n\nThe evaluation phases (T0, T1, T2, T3) will be conducted through data derived from: 1) self-administered and paper-based questionnaires, validated in the Italian language; 2) the clinical assessment of patients; 3) the m-health solution, as data automatically derived from the m-health solution; 4) a focus group carried out in a subsample of participants.\n\nData regarding different health-related areas (T2DM severity; medication adherence; lifestyle habits; self-efficacy related to management of the disease; quality of life), usability of the m-health solution, participants' experience with the intervention, utilization of the m-health solution by the patients, and the cost-effectiveness of the intervention, will be evaluated.\n\nPatients participating in the study will not be required to make any additional visits or undergo any laboratory analysis beyond those specified in their therapeutic plan.",[218],"Diabetes Type 2",[220,221,222,223,224],"self-management","digital solution","Diabete type 2","Chronic diseases","glycated hemoglobin","2025-12-30",{"date":227,"type":228},"2025-12-31","ACTUAL",{"date":230,"type":228},"2025-10-13",{"date":232,"type":212},"2026-12-31",{"name":5,"class":6},13]