[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572867":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":221,"collaborators":223,"id":227,"slug":18,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":18,"eligibilityCriteria":232,"healthyVolunteers":228,"sex":233,"minAge":234,"maxAge":18,"enrollmentInfo":235,"targetDuration":18,"studyType":238,"phases":239,"briefSummary":241,"conditions":242,"keywords":246,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},{"fullName":5,"class":6},"DiappyMed","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","The interventional device EkiYou V2 will be used at inclusion following randomization.",[13],"Device: EkiYou V2",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Control arm with standard care for the first three months. Participants use their standard basal bolus management method by fixed doses or flexible insulin therapy.\n\nAfter the initial three-months control period, participants will benefit from the investigational device EkiYou V2.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","EkiYou V2","Use of a Digital Therapy in the form of a mobile application that helps users to evaluate their daily bolus and basal insulin needs, and that adjusts at weekly basis their insulin to carb ratios, correction factor and basal dose.\n\nThe device includes the following features to participants:\n\n* Carbohydrate counting through an extensive food database with more than 200k items.\n* Bolus calculation based on their meal, physical activity and blood glucose.\n* Bolus correction advice.\n* Long-acting insulin reminders and automatic periodic titration.\n* Insulin-to-carb ratios and correction factor automatic adjustment.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Omar Diouri, PhD","CONTACT","+33 6 27 17 79 49","omar.diouri@diappymed.com",[32,48,60,72,84,96,108,120,132,143,155,167,179,191,200,212],{"facility":33,"status":34,"city":35,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"APHP Avicennes","RECRUITING","Bobigny","France","FR",{"type":39,"coordinates":40},"Point",[41,42],2.45012,48.90982,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":18,"phoneExt":18,"email":47},"Emmanuel Cosson","emmanuel.cosson@aphp.fr",{"facility":49,"status":34,"city":50,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"CHU CAEN","Caen",{"type":39,"coordinates":52},[53,54],-0.35912,49.18585,{"lat":54,"lon":53},[57],{"name":58,"role":28,"phone":18,"phoneExt":18,"email":59},"Michael Joubert","joubert-m@chu-caen.fr",{"facility":61,"status":34,"city":62,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"IDNC","Chartres",{"type":39,"coordinates":64},[65,66],1.48925,48.44685,{"lat":66,"lon":65},[69],{"name":70,"role":28,"phone":18,"phoneExt":18,"email":71},"Said Bekka","zgouga@aol.com",{"facility":73,"status":34,"city":74,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"CHSF Corbeil-Essonnes","Corbeil-Essonnes",{"type":39,"coordinates":76},[77,78],2.48757,48.60603,{"lat":78,"lon":77},[81],{"name":82,"role":28,"phone":18,"phoneExt":18,"email":83},"Alfred Penfornis","alfred.penfornis@chsf.fr",{"facility":85,"status":34,"city":86,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Cabinet Dr Picard","Dijon",{"type":39,"coordinates":88},[89,90],5.01391,47.31344,{"lat":90,"lon":89},[93],{"name":94,"role":28,"phone":18,"phoneExt":18,"email":95},"Sylvie Picard","DocSylviePicard@diabetes21.fr",{"facility":97,"status":34,"city":98,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"GH Le Havre - Hôpital Jacques Monod","Le Havre",{"type":39,"coordinates":100},[101,102],0.10785,49.49346,{"lat":102,"lon":101},[105],{"name":106,"role":28,"phone":18,"phoneExt":18,"email":107},"Clémence Bures","clemence.bures@ch-havre.fr",{"facility":109,"status":34,"city":110,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"CHU Limoges - Dupuytren","Limoges",{"type":39,"coordinates":112},[113,114],1.24759,45.83362,{"lat":114,"lon":113},[117],{"name":118,"role":28,"phone":18,"phoneExt":18,"email":119},"Laurence Salle","laurence.salle@unilim.fr",{"facility":121,"status":34,"city":122,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Fondation Ambroise Paré \u002F HEM","Marseille",{"type":39,"coordinates":124},[125,126],5.38107,43.29695,{"lat":126,"lon":125},[129],{"name":130,"role":28,"phone":18,"phoneExt":18,"email":131},"Pauline SCHAEPELYNCK","p.schaepelynck@hopital-europeen.fr",{"facility":133,"status":34,"city":134,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Cabinet Dr Navaranne","Mérignac",{"type":39,"coordinates":136},[137,138],-0.64512,44.84247,{"lat":138,"lon":137},[141],{"name":142,"role":28,"phone":18,"phoneExt":18,"email":18},"Anne Navaranne",{"facility":144,"status":34,"city":145,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"University Hospital, Montpellier","Montpellier",{"type":39,"coordinates":147},[148,149],3.87635,43.61093,{"lat":149,"lon":148},[152],{"name":153,"role":28,"phone":18,"phoneExt":18,"email":154},"Eric Renard","e-renard@chu-montpellier.fr",{"facility":156,"status":34,"city":157,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"APHP - 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Hôpital Rangueil","Toulouse",{"type":39,"coordinates":204},[205,206],1.44367,43.60426,{"lat":206,"lon":205},[209],{"name":210,"role":28,"phone":18,"phoneExt":18,"email":211},"Hélène Hanaire","hanaire.h@chu-toulouse.fr",{"facility":213,"status":34,"city":202,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":214,"geoPoint":216,"contacts":217},"Clinique Pasteur",{"type":39,"coordinates":215},[205,206],{"lat":206,"lon":205},[218],{"name":219,"role":28,"phone":18,"phoneExt":18,"email":220},"Christine Rouby","crouby@clinique-pasteur.com",{"type":222,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[224],{"name":225,"class":226},"Sanoia","OTHER","100572867",false,"NCT06738849","EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation","EkiYou-Study-2 : Multicenter Randomised Controlled Trial of the EkiYou Application for Insulin Bolus Calculation","Inclusion Criteria:\n\n* be aged 18 or over,\n* have type 1 or type 2 diabetes or diabetes secondary to pancreatic disease,\n* have been treated with multi-injection basal\u002Fbolus insulin therapy for at least 6 months,\n* using a compatible rapid insulin with the device Ekiyou such as : Novorapid, Humalog, Apidra, Asparte Sanofi, Fiasp or Lyumjev,\n* using a compatible long-acting insulin with the device EkiYou such as : Lantus, Abasaglar, Toujeo, Levemir or Tresiba,\n* have been using a continuous glucose monitoring device such as Dexcom G6, Dexcom One, Dexcom One+ or FreeStyle Libre for at least 3 months,\n* have given their physician access to their glucose data via a glucose data management platform,\n* for type 2 diabetic patients using an hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors), have no change in dosage regimen for at least 3 months\n* have recorded at least 70% of CGM data over a 14-day window close to the inclusion date,\n* have at least one smartphone running Android 5.0 or higher or iOS 12.0 or higher connected to the internet and able to receive CGM data available to them on the day of the inclusion,\n* able to read or use a smartphone with no visual impairment needing specific typography,\n* for patients of childbearing potential, a pregnancy test must have been carried out prior to inclusion, or an effective and adequate method of contraception must be used,\n* be affiliated to a French social security scheme.\n\nExclusion Criteria:\n\n* pregnant or breast-feeding women,\n* type 1 diabetic patients treated with any hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors),\n* insulin-resistant patient: prescribed daily insulin dose \\> 1 U\u002Fkg\u002Fday or \\> 200 U\u002Fday,\n* patient with very low insulin requirements: daily insulin dose \\\u003C 15 U\u002Fday,\n* patient with gastroparesis,\n* diabetic ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within the 6 months prior to inclusion,\n* pancreatic disease secondary to chronic ethanolism,\n* known medical condition that, in the investigator's opinion, may interfere with the protocol,\n* patient who cannot be monitored for 3 months,\n* intellectual ability compromising use of the application, comprehension or completion of questionnaires,\n* participation in another clinical trial or administration of a non-authorised drug in the 4 weeks preceding the screening,\n* person taking part in another research study with an exclusion period still in progress,\n* under guardianship or curatorship,\n* imprisoned or otherwise deprived of liberty.","ALL","18 Years",{"count":236,"type":237},154,"ESTIMATED","INTERVENTIONAL",[240],"NA","EkiYou-Study-2 is an interventional multicenter randomised controlled clinical investigation according to EU 2017\u002F745. It is conducted in 154 adults with diabetes and treated by multiple daily insulin injections that will be followed for 6 months.\n\nAfter a randomization, participants will receive for 6 months EkiYou V2 Digital Therapy that will help them to estimate their daily bolus and basal insulin doses. This device weekly adjusts insulin parameters including : basal insulin dose, insulin to carb ratios and correction factor.\n\nThe control group will stay with their standard care, and after the first three months of control period, they will receive EkiYou V2 for the last three months.\n\nThe aim of this study is to examine the performance of the EkiYou V2 Digital Therapy compared with conventional methods for people with diabetes treated with multi-injections as part of a basal-bolus regimen. We also aim to assess the level of satisfaction and user experience with the EkiYou application, as well as the quality of life of study participants.",[243,244,245],"Diabetes Type 1","Diabetes Type 2 on Insulin","Pancreatogenous Diabetes",[247,248,249,250],"decision support system","digital therapy","bolus advisor","flexible insulin therapy","2025-06-17",{"date":253,"type":254},"2025-06-18","ACTUAL",{"date":256,"type":254},"2024-11-05",{"date":258,"type":237},"2026-11-30",{"name":5,"class":6},16]