[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658104":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":40,"overallOfficials":45,"centralContacts":50,"locations":56,"responsibleParty":83,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":11,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":111,"whyStopped":11,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Difference in Time in Range (0.70-1.80 g\u002FL) between baseline (M0) and Month 6 (M6)",null,"Baseline and 6 months",[14,17,20,22,24,26,28],{"measure":15,"description":11,"timeFrame":16},"Difference in time spent in the glycemic target range (Time in Range, TIR between 0.70 g\u002FL and 1.80 g\u002FL) between M3 and M0","Baseline and 3 months",{"measure":18,"description":11,"timeFrame":19},"Difference in time spent in hypoglycemia (Time Below Range, TBR \u003C 0.70 g\u002FL) between M3 and M0 and between M6 and M0","Baseline, 3 months and 6 months",{"measure":21,"description":11,"timeFrame":19},"Difference in time spent in severe hypoglycemia (Time Below Range, TBR \u003C 0.54 g\u002FL) between M3 and M0 and between M6 and M0",{"measure":23,"description":11,"timeFrame":19},"Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g\u002FL) between M3 and M0 and between M6 and M0",{"measure":25,"description":11,"timeFrame":19},"Difference in time spent in severe hyperglycemia (Time Above Range, TAR > 2.50 g\u002FL) between M3 and M0 and between M6 and M0",{"measure":27,"description":11,"timeFrame":19},"Difference in glucose variability coefficient between M3 and M0 and between M6 and M0",{"measure":29,"description":11,"timeFrame":19},"Difference in Glucose Management Indicator (GMI) between M3 and M0 and between M6 and M0",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":31,"timePerspective":32,"maskingInfo":11},"COHORT","RETROSPECTIVE","Type 1 diabetes requires continuous adjustment of insulin doses according to carbohydrate intake. In France, an interprofessional cooperation protocol implemented in 2023 authorizes trained dietitians to adjust insulin-to-carbohydrate ratios under physician supervision.\n\nThis retrospective multicenter cohort study will evaluate whether this organization improves glycemic control in routine clinical practice. Data will be collected from medical records and glucose monitoring platforms without modifying patient management.\n\nThe primary outcome is the difference in Time in Range (0.70-1.80 g\u002FL) between baseline (M0) and Month 6 (M6). Secondary outcomes include differences in hypoglycemia, hyperglycemia, glucose variability and Glucose Management Indicator (GMI) assessed between baseline and follow-up visits at Month 3 and Month 6.","Adults aged 18-69 years with type 1 diabetes or insulin-deficient diabetes receiving routine care under an interprofessional cooperation protocol for prandial insulin dose adjustment. Eligible participants must have had diabetes for more than 6 months, be treated with multiple daily insulin injections or an insulin pump, and have completed structured education in functional insulin therapy. Patients with unstable proliferative retinopathy, pregnancy, other types of diabetes, temporary treatments affecting insulin requirements, legal protection measures, or who object to the use of their data are excluded",[36],{"label":37,"type":11,"description":11,"interventionNames":38},"Patients receiving routine care under a cooperation protocol for prandial insulin adjustment",[39],"Other: Routine care data collection",[41],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"Routine care data collection","Data collection from patients receiving standard care under a cooperation protocol for prandial insulin dose adjustment, with data collected from patients' medical records and glucose monitoring platforms without modifying patient management",[37],[46],{"name":47,"affiliation":48,"role":49},"Virginie Lafaille","Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":11,"email":55},"Youcef Sekour","CONTACT","+33156095823","youcef.sekour@aphp.fr",[57,74],{"facility":58,"status":11,"city":59,"state":11,"zip":11,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Service de diabétologie, Hôpital Lariboisière - AP-HP","Paris","France","FR",{"type":63,"coordinates":64},"Point",[65,66],2.3488,48.85341,{"lat":66,"lon":65},[69,73],{"name":70,"role":53,"phone":71,"phoneExt":11,"email":72},"Hélène Louvet","+33149959014","hélène.louvet@aphp.fr",{"name":70,"role":49,"phone":11,"phoneExt":11,"email":11},{"facility":48,"status":11,"city":59,"state":11,"zip":11,"country":60,"countryCode":61,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},{"type":63,"coordinates":76},[65,66],{"lat":66,"lon":65},[79,82],{"name":47,"role":53,"phone":80,"phoneExt":11,"email":81},"+33156095161","virginie.lafaille@aphp.fr",{"name":47,"role":49,"phone":11,"phoneExt":11,"email":11},{"type":84,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[86],{"name":87,"class":88},"GIRCI IDF","UNKNOWN","100658104","impact-of-dietary-intervention-within-an-interprofessional-cooperative-protocol-for-prandial-insulin-dose-adjustment-in-people-living-with-type-1-diabetes-100658104",false,"NCT07846852","Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes","INSUDIETCOOP","Inclusion Criteria:\n\n* Male or female, aged 18 to 69 years.\n* Receiving routine clinical care under an interprofessional cooperation protocol for prandial insulin dose adjustment (protocol implemented since January 1, 2023).\n* Living with type 1 diabetes mellitus or insulin-deficient diabetes, confirmed by the presence of anti-GAD, anti-IA2, anti-ZnT8, or insulin autoantibodies, and requiring optimization of insulin therapy.\n* Diabetes duration greater than 6 months.\n* Treated with multiple daily insulin injections or an insulin pump (open-loop or hybrid closed-loop system).\n* Completion of a structured therapeutic education program in functional insulin therapy (individual consultations and\u002For educational workshops).\n* Able to understand study information and procedures.\n\nExclusion Criteria:\n\n* Unstable severe proliferative diabetic retinopathy.\n* Any type of diabetes other than type 1 diabetes or insulin-deficient diabetes.\n* Pregnant women with type 1 diabetes.\n* Current treatment with temporary therapies that may affect insulin requirements (e.g., chemotherapy or systemic corticosteroid therapy).\n* Individuals under legal guardianship, curatorship, or any other legal protection measure.\n* Objection to the use of personal data for research purposes","ALL","18 Years","69 Years",{"count":100,"type":101},163,"ESTIMATED","OBSERVATIONAL","This retrospective multicenter cohort study aims to evaluate the effectiveness of an interprofessional cooperative protocol allowing dietitians to adjust prandial insulin-to-carbohydrate ratios in adults living with type 1 diabetes receiving functional insulin therapy. Glycemic outcomes will be assessed using continuous glucose monitoring data collected during routine clinical care. The primary endpoint is the change in Time in Range (TIR) between baseline and 6 months.",[105],"Diabetes Mellitus, Type 1",[107,108,109,110],"Interprofessional cooperative protocol","Prandial insulin","Type 1 diabetes","Dietitian","NOT_YET_RECRUITING","2026-09-22",{"date":114,"type":115},"2026-09-29","ACTUAL",{"date":117,"type":101},"2026-10",{"date":119,"type":101},"2028-04",{"name":5,"class":6},2]