[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657325":3},{"organization":4,"outcomesModule":7,"designInfo":133,"detailedDescription":11,"studyPopulation":136,"armGroups":11,"interventions":137,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":142,"collaborators":144,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":11,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":11,"enrollmentInfo":157,"targetDuration":11,"studyType":160,"phases":11,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":177,"whyStopped":11,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":11},{"fullName":5,"class":6},"mylife Diabetes Care AG","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in the percentage of time in the 70 - 180 mg\u002FdL range (TIR) at 12 Months",null,"Baseline and 12 Months",[14,17,20,22,24,26,28,30,32,34,36,38,40,41,43,44,46,47,49,50,52,53,55,56,58,59,61,62,64,65,67,68,70,71,73,74,76,77,79,80,82,83,85,86,88,89,91,92,94,95,97,98,100,101,103,104,106,107,109,110,113,115,118,119,121,122,125,127,129,130,132],{"measure":15,"description":11,"timeFrame":16},"Percentage of time in the 70 - 180 mg\u002FdL range (TIR) at 6 months","Baseline and 6 months",{"measure":18,"description":11,"timeFrame":19},"Percentage of time in the 70 - 140 mg\u002FdL range (TITR) at 6 Months","Baseline and 6 Months",{"measure":21,"description":11,"timeFrame":12},"Percentage of time in the 70 - 140 mg\u002FdL range (TITR) at 12 Months",{"measure":23,"description":11,"timeFrame":19},"Percentage of time above 250 mg\u002FdL (TAR > 250 mg\u002FdL) at 6 Months",{"measure":25,"description":11,"timeFrame":12},"Percentage of time above 250 mg\u002FdL (TAR > 250 mg\u002FdL) at 12 Months",{"measure":27,"description":11,"timeFrame":19},"Percentage of time above 180 mg\u002FdL (TAR > 180 mg\u002FdL) at 6 Months",{"measure":29,"description":11,"timeFrame":12},"Percentage of time above 180 mg\u002FdL (TAR > 180 mg\u002FdL) at 12 Months",{"measure":31,"description":11,"timeFrame":19},"Percentage of time below 70 mg\u002FdL (TBR \u003C 70 mg\u002FdL) at 6 Months",{"measure":33,"description":11,"timeFrame":12},"Percentage of time below 70 mg\u002FdL (TBR \u003C 70 mg\u002FdL) at 12 Months",{"measure":35,"description":11,"timeFrame":19},"Percentage of time below 54 mg\u002FdL (TBR \u003C 54 mg\u002FdL) at 6 Months",{"measure":37,"description":11,"timeFrame":12},"Percentage of time below 54 mg\u002FdL (TBR \u003C 54 mg\u002FdL) at 12 Months",{"measure":39,"description":11,"timeFrame":19},"Mean glucose derived from CGM data (mg\u002FdL)",{"measure":39,"description":11,"timeFrame":12},{"measure":42,"description":11,"timeFrame":19},"Glucose standard deviation (SD) derived from CGM data (mg\u002FdL)",{"measure":42,"description":11,"timeFrame":12},{"measure":45,"description":11,"timeFrame":19},"Glucose coefficient of variation (CV) derived from CGM data",{"measure":45,"description":11,"timeFrame":12},{"measure":48,"description":11,"timeFrame":19},"Glucose Management Indicator (GMI) derived from CGM data",{"measure":48,"description":11,"timeFrame":12},{"measure":51,"description":11,"timeFrame":19},"Glucose Risk Index (GRI) derived from CGM data",{"measure":51,"description":11,"timeFrame":12},{"measure":54,"description":11,"timeFrame":19},"Change in HbA1c levels (%)",{"measure":54,"description":11,"timeFrame":12},{"measure":57,"description":11,"timeFrame":19},"Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)",{"measure":57,"description":11,"timeFrame":12},{"measure":60,"description":11,"timeFrame":19},"Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)",{"measure":60,"description":11,"timeFrame":12},{"measure":63,"description":11,"timeFrame":19},"Patients \u003C13: Quality of Life questionnaire (animated emoji scale)",{"measure":63,"description":11,"timeFrame":12},{"measure":66,"description":11,"timeFrame":19},"Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)",{"measure":66,"description":11,"timeFrame":12},{"measure":69,"description":11,"timeFrame":19},"Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)",{"measure":69,"description":11,"timeFrame":12},{"measure":72,"description":11,"timeFrame":19},"Patients \u003C 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)",{"measure":72,"description":11,"timeFrame":12},{"measure":75,"description":11,"timeFrame":19},"Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)",{"measure":75,"description":11,"timeFrame":12},{"measure":78,"description":11,"timeFrame":19},"Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)",{"measure":78,"description":11,"timeFrame":12},{"measure":81,"description":11,"timeFrame":19},"Patients aged \u003C 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)",{"measure":81,"description":11,"timeFrame":12},{"measure":84,"description":11,"timeFrame":19},"Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)",{"measure":84,"description":11,"timeFrame":12},{"measure":87,"description":11,"timeFrame":19},"Patients aged \u003C 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)",{"measure":87,"description":11,"timeFrame":12},{"measure":90,"description":11,"timeFrame":19},"Patients aged ≥ 18 years: INSPIRE questionnaire",{"measure":90,"description":11,"timeFrame":12},{"measure":93,"description":11,"timeFrame":19},"Patients aged 13-17 years: INSPIRE Youth questionnaire",{"measure":93,"description":11,"timeFrame":12},{"measure":96,"description":11,"timeFrame":19},"Patients \u003C 13 years: INSPIRE Parent questionnaire",{"measure":96,"description":11,"timeFrame":12},{"measure":99,"description":11,"timeFrame":19},"Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire",{"measure":99,"description":11,"timeFrame":12},{"measure":102,"description":11,"timeFrame":19},"Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire",{"measure":102,"description":11,"timeFrame":12},{"measure":105,"description":11,"timeFrame":19},"Patients aged \u003C 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire",{"measure":105,"description":11,"timeFrame":12},{"measure":108,"description":11,"timeFrame":19},"Patients ≥ 13 years \u002F Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire",{"measure":108,"description":11,"timeFrame":12},{"measure":111,"description":11,"timeFrame":112},"Changes in quality of life, mental health, treatment satisfaction, diabetes burden and sleep quality: Patient Global Impression of Change (PGIC)","at 12 Months",{"measure":114,"description":11,"timeFrame":112},"Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode",{"measure":116,"description":11,"timeFrame":117},"Percentage of time in hybrid closed-loop (%)","at 6 Months",{"measure":116,"description":11,"timeFrame":112},{"measure":120,"description":11,"timeFrame":117},"Percentage of time using different system features (%)",{"measure":120,"description":11,"timeFrame":112},{"measure":123,"description":11,"timeFrame":124},"Number of Safety \u002F Adverse Events: Severe Hypoglycemia","At 6 Months",{"measure":123,"description":11,"timeFrame":126},"At 12 Months",{"measure":128,"description":11,"timeFrame":124},"Number of Safety \u002F Adverse Events: Diabetic Ketoacidosis (DKA)",{"measure":128,"description":11,"timeFrame":126},{"measure":131,"description":11,"timeFrame":124},"Number of Safety \u002F Adverse Events: Unplanned diabetes-related hospitalizations",{"measure":131,"description":11,"timeFrame":126},{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":134,"timePerspective":135,"maskingInfo":11},"COHORT","PROSPECTIVE","The study population will be recruited in France from 20 public or private hospitals and clinics which are qualified as insulin pump initiating centers according to national health reimbursement criteria.",[138],{"type":139,"name":140,"description":141,"armGroupLabels":11,"otherNames":11},"OTHER","No Intervention: Observational Cohort","Observational Cohort",{"type":143,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[145],{"name":146,"class":147},"Abbott Diabetes Care, Inc - providing financial support for the study","UNKNOWN","100657325","impact-of-the-myloop-powered-by-camaps-fx-system-in-combination-with-freestyle-libre-3--3-plus-sensors-on-t1d-patients-in-france-100657325",false,"NCT07835685","Glycemic Control and Quality of Life Evolution for Patients With T1D Using the myLoop Powered by CamAPS FX System in Combination With FreeStyle Libre 3 \u002F 3 Plus Sensors in France","Evolution in Glycemic Control and Quality of Life in Patients With Type 1 Diabetes Using the myLoop System With FreeStyle Libre 3 \u002F 3 Plus Sensors in a Real-World Setting in France","Inclusion Criteria:\n\n* Patient has Type 1 Diabetes.\n* Patient is 2 years or older if using FreeStyle Libre 3 Plus.\n* Patient is 4 years or older if using FreeStyle Libre 3.\n* Patient and their diabetes doctor have decided that the patient will use the myLoop with CamAPS FX and the FreeStyle Libre 3 or FreeStyle Libre 3 Plus as part of their diabetes treatment.\n* The patient, or their parent\u002Flegal guardian if they are under 18, has a smartphone that works with CamAPS FX.\n* The patient, or their parent\u002Flegal guardian if they are under 18, has a working email address and mobile phone number.\n\nFor adult patients:\n\n* The patient has received the study information and has signed a consent form agreeing to take part in the study and to the use of their personal data for the study.\n* Patient can read and understand French.\n* Patient agrees to complete the online questionnaires and is able to use a smartphone.\n\nFor patients under 18 years of age:\n\n* The patient's parent(s) or legal guardian(s) signed a consent form agreeing for the patient to take part in the study and for the patient's personal data to be used for the study. At least one parent or legal guardian must provide consent, as applicable. The patient will also be asked, appropriate for their age and understanding, to agree to take part in the study.\n* Patient and\u002For their parent or legal guardian, as applicable, can read and understand French.\n* Patient is old enough to complete the questionnaires, or their parent or legal guardian agrees to complete the online questionnaires; the person completing the questionnaires is able to use a smartphone.\n\nExclusion Criteria:\n\n* Patient is currently using, or has used in the past 6 months, any hybrid closed-loop, fully closed-loop, or homemade (\"do-it-yourself\") closed-loop system.\n* Patient is under a legal protection measure, such as guardianship or another form of court-ordered protection.\n* Patient has a medical reason why the myLoop with CamAPAS FX and FreeStyle Libre 3\u002F3 Plus system should not be used, including any reason listed in the most recent instructions for use of any of these medical devices.\n* Patient has an unresolved skin condition where the sensor and\u002For pump tubing would be placed, such as psoriasis, dermatitis herpetiformis, a skin rash, or a staphylococcal (staph) infection.\n* Patient is expected to not be able to continue follow-up at the study center for the next 12 months.","ALL","2 Years",{"count":158,"type":159},220,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn how glucose control changes over one year in people with type 1 diabetes who use the myLoop with CamAPS FX and Freestyle Libre 3 or FreeStyle Libre 3 Plus during usual care in France. The main question it aims to answer is:\n\n• How time in range (TIR) changes after one year of use. Time in range is the percentage of time glucose levels stay within the target range.\n\nAs secondary aims, the study aims to answer how other glucose measures (other than TIR, for example Time Above \u002F Below Range) change at six months and one year.\n\nParticipants who are prescribed the myLoop with CamAPS FX during usual care for Type 1 Diabetes will:\n\n* agree to have their routine clinical data on diabetes management and related complications before and after starting therapy with myLoop with CamAPS FX used for this study.\n* answer online survey questions about their quality of life, use of the device and features and treatment satisfaction at six months and one year.",[163],"Diabetes Type 1",[165,166,167,168,169,170,171,172,173,174,175,176],"Type 1 Diabetes","Pancreas, Artificial","CGM Device","Insulin Infusion System","Hybrid Closed Loop","CamAPS FX","myLoop","YpsoPump insulin pump","Real-World prospective study","Glucose Metabolism Disorders","Autoimmune Diseases","Endocrine System Diseases","NOT_YET_RECRUITING","2026-09-28",{"date":180,"type":181},"2026-10-01","ACTUAL",{"date":183,"type":159},"2026-10",{"date":185,"type":159},"2028-04",{"name":5,"class":6}]