[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652412":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":19,"studyPopulation":19,"armGroups":43,"interventions":56,"overallOfficials":19,"centralContacts":65,"locations":71,"responsibleParty":87,"collaborators":19,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":19,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":19,"enrollmentInfo":100,"targetDuration":19,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":19,"overallStatus":74,"whyStopped":19,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Monastir","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":19},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Blood Glucose Level (mmol\u002FL)","Change in blood glucose level, measured in mmol\u002FL, from baseline to 6 months, comparing the telemonitoring group with the standard diabetes care group.","Baseline to 6 months",{"measure":14,"description":15,"timeFrame":12},"Change in Glycated Hemoglobin (HbA1c) (%)","Change in glycated hemoglobin (HbA1c), measured as a percentage (%), from baseline to 6 months, comparing the telemonitoring group with the standard diabetes care group.",[17,20,22,24,26,28,31,33,35],{"measure":18,"description":19,"timeFrame":12},"Change in body weight",null,{"measure":21,"description":19,"timeFrame":12},"Change in body mass index (BMI)",{"measure":23,"description":19,"timeFrame":12},"Change in urinary albumin concentration measured in mg\u002FL.",{"measure":25,"description":19,"timeFrame":12},"Medication adherence assessed by MARS-5",{"measure":27,"description":19,"timeFrame":12},"Medication adherence assessed by Medication Possession Ratio (MPR)",{"measure":29,"description":30,"timeFrame":12},"Change in Skin Autofluorescence (AGEs) Measured by AGE Reader","Skin autofluorescence, reflecting tissue accumulation of advanced glycation end-products (AGEs), will be measured using the AGE Reader. The change in skin autofluorescence from baseline to 6 months will be reported.",{"measure":32,"description":19,"timeFrame":12},"Change in reactive hyperemia index (RHI)",{"measure":34,"description":19,"timeFrame":12},"Number of Participants with Hospitalizations",{"measure":36,"description":19,"timeFrame":12},"Number of Participants with Emergency Department Visits",{"allocation":38,"interventionModel":39,"interventionModelDescription":19,"primaryPurpose":40,"observationalModel":19,"timePerspective":19,"maskingInfo":41},"RANDOMIZED","PARALLEL","HEALTH_SERVICES_RESEARCH",{"masking":42,"maskingDescription":19,"whoMasked":19},"NONE",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Telemonitoring Group","EXPERIMENTAL","Participants in the telemonitoring group receive a connected blood glucose meter, which automatically transmits all blood glucose readings to a dedicated online telemonitoring platform.",[49],"Device: Telemonitoring group",{"label":51,"type":52,"description":53,"interventionNames":54},"Standard Care Group","ACTIVE_COMPARATOR","Participants in the usual care group will receive standard diabetes management according to routine clinical practice, at the discretion of their treating physicians. The standard follow-up will include at least three scheduled study visits at Day 15, Month 3, and Month 6. The same clinical and study data will be collected at each visit as in the telemonitoring group.",[55],"Other: Usual Care Group",[57,61],{"type":58,"name":59,"description":47,"armGroupLabels":60,"otherNames":19},"DEVICE","Telemonitoring group",[45],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":19},"Usual Care Group","Standard follow-up will including at least three scheduled study visits at Day 15, Month 3, and Month 6.",[51],[66],{"name":67,"role":68,"phone":69,"phoneExt":19,"email":70},"Nouira Semir","CONTACT","0021673106046","semir.nouira@rns.tn",[72],{"facility":73,"status":74,"city":75,"state":19,"zip":19,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"University Hospital Fattouma Bourguiba Monastir","RECRUITING","Monastir","Tunisia","TN",{"type":79,"coordinates":80},"Point",[81,82],10.82617,35.77799,{"lat":82,"lon":81},[85],{"name":86,"role":68,"phone":69,"phoneExt":19,"email":70},"Nouira Semir, Professor",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Pr. Semir Nouira","Professor","100652412","effectiveness-and-utility-of-telemonitoring-in-improving-the-glycaemic-control-of-diabetes-mellitus-tunisian-patients-100652412",false,"NCT07774078","Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Diabetes Mellitus Tunisian Patients","Evaluation of the Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Tunisian Patients With Diabetes Mellitus: a Study Protocol","Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus with HbA1c between 7% and 10%.\n* Stable antidiabetic treatment for at least 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Serum creatinine \\>200 µmol\u002FL.\n* Acute coronary syndrome or stroke.\n* Dementia.\n* Pregnancy.\n* Inability to participate in or comply with the telemonitoring intervention.\n* Severe diabetic retinopathy.","ALL","18 Years",{"count":101,"type":102},260,"ESTIMATED","INTERVENTIONAL",[105],"NA","The study aims to evaluate the impact of a telemonitoring system on glycemic control in patients with diabetes in Tunisia. Participants in the intervention group will receive remote diabetes management through a dedicated mobile application and web platform, while the control group will receive standard diabetes care. The primary objective is to determine the effectiveness of telemonitoring in improving glycemic control, as assessed by changes in glycated hemoglobin (HbA1c) and blood glucose levels.",[108,109],"Diabete Mellitus","Telemonitoring","2026-08-19",{"date":112,"type":113},"2026-08-20","ACTUAL",{"date":115,"type":113},"2024-08-01",{"date":117,"type":102},"2026-12-31",{"name":5,"class":6},1]