[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595364":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":20,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Implementation of FLEX-AP system","EXPERIMENTAL","This is a preliminary, exploratory non-randomized, longitudinal, crossover study involving patients with T1D who are habitual userss of the Minimed 780G hybrid closed-loop system. This study consists of two sequentials phases, starting wiht the Minimed 780G hybrid closed-loop system and transitioning to the FLEX-AP system, with no randomization of treatment order.",[13],"Device: FLEX-AP system will be implemented to T1D patients",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","FLEX-AP system will be implemented to T1D patients","A FLEX-AP system will be implemented to T1D patients after they have been given a Minimed 780G hybrid closed-loop system",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Jorge Bondia, PhD","Universitat Politecnica Valencia, Spain","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Lía Nattero-Chávez, MD","CONTACT","+34 913369029","marialia.nattero@salud.madrid.org",{"name":23,"role":29,"phone":30,"phoneExt":20,"email":33},"jbondia@isa.upv.es",[35],{"facility":36,"status":20,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hospital Universitario Ramón y Cajal","Madrid","28034","Spain","ES",{"type":42,"coordinates":43},"Point",[44,45],-3.70256,40.4165,{"lat":45,"lon":44},[48,49,51,52],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":20},{"name":50,"role":29,"phone":30,"phoneExt":20,"email":33},"Jorge Bondía, PhD",{"name":28,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":53,"role":25,"phone":20,"phoneExt":20,"email":20},"Jorge Bondia Company, PhD",{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57],{"name":58,"class":6},"Universitat Politècnica de València","100595364","relieving-carb-counting-via-flexible-userinteraction-multiple-input-control-architectures-100595364",false,"NCT07031492","Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures","Beyond Hybrid Artificial Pancreas Systems: Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures","FLEX-AP","Inclusion Criteria:\n\n* Aged 18-60 years inclusive.\n* T1D as per the American Diabetes Association classification for \\>12 months prior to the screening visit.\n* Minimed 780G®-hybrid closed-loop system users for at least 6 months. Use of automatic mode (Smartguard) \\> 80% of the time.\n* A1c level below 9.0% at Screening visit.\n* Assessment of albuminuria and retinal tests, which should have yielded negative results for advanced medical complications.\n* Willing and able to adhere to the study protocol\n\nExclusion Criteria:\n\n* Not having met the previous criteria for inclusion.\n* Females who are pregnant or intend to become pregnant during the study period; a positive pregnancy test at screening will result in exclusion.\n* Breastfeeding.\n* Use of any non-insulin glucose-lowering therapy within three months prior to study initiation.\n* Presence of moderate\u002Fsevere renal impairment, defined as an estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73 m².\n* History of severe hypoglycemia (defined as coma or convulsion requiring assistance from others) or diabetic ketoacidosis in the six months prior to study initiation.\n* Hypoglycemia unawareness (defined as Clarke Test score greater than 3).\n* Occurrence of an acute cardiovascular event (e.g., myocardial infarction, unstable angina, stroke) within twelve months prior to study initiation.\n* History of drug or alcohol abuse. History of any active or suspected malignancy.\n* Clinically significant microvascular complications (such as macroalbuminuria, preproliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine, or other systemic conditions, apart from T1D, that may hinder the implementation of the clinical study protocol or the interpretation of study results.\n* Diabetic gastroparesis.\n* Scheduled surgery during the study period.\n* Adherence to a very low carbohydrate diet, defined as a carbohydrate intake of less than 40 grams per day.\n* Presence of any comorbid medical or psychological condition deemed by the investigators to render the individual unsuitable for study participation.\n* Known allergy to insulin NovoRapid.\n* Regular practice of competitive or very high intensity physical activity.","ALL","18 Years","60 Years",{"count":71,"type":72},10,"ESTIMATED","INTERVENTIONAL",[75],"NA","Developing algorithms for Automated Insulin Delivery (AID) systems that alleviate the burden of meal announcements, culminating in the FLEX-AP system. This fully automated artificial pancreas system is designed to operate without meal or exercise announcements while allowing for optional user input. FLEX-APaims to achieve a balance between glycemic control and user quality of life by incorporating user preferences into its operation.\n\nThe FLEX-AP system features a flexible control architecture tailored to handle unannounced meals and exercise. It also allows for optional meal announcements and offers guidance for mitigating hypoglycemia, such as counterregulatory actions like rescue carbohydrate intake for patients who prefer it. The proposed benefit of FLEX-AP is to improve glycemic control while respecting individual preferences, which sets it apart from existing AID systems.",[78],"T1DM - Type 1 Diabetes Mellitus","NOT_YET_RECRUITING","2025-06-12",{"date":82,"type":83},"2025-06-22","ACTUAL",{"date":85,"type":72},"2025-09",{"date":87,"type":72},"2025-12",{"name":5,"class":6},1]