protocolSection identificationModule nctId: NCT06283797, orgStudyIdInfo id: RECHMPL22_0346, secondaryIdInfos id: 2023-A01661-44, type: OTHER, domain: ANSM, briefTitle: Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes, acronym: APATDIAGNOSIS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: Hopital Universitaire Robert-Debre, collaborators name: University Hospital, Tours, collaborators name: University Hospital, Angers, collaborators name: University of Virginia, descriptionModule briefSummary: The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use.The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase., conditionsModule conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized control study in parallel groups, followed by a non randomized extension, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: OmniPod 5, interventions name: Dexcom G6, interventions name: PAID questionnaires, outcomesModule primaryOutcomes measure: Glycated hemoglobin (HbA1c) level, secondaryOutcomes measure: Percent of time spent in the 70-180 mg/dl glucose range, secondaryOutcomes measure: Percent of time spent in the 70-140 mg/dl glucose range, secondaryOutcomes measure: Mean glucose level, secondaryOutcomes measure: Percent of time spent with glucose level below 70 mg/dl, secondaryOutcomes measure: Percent of time spent with glucose level below 54 mg/dl, secondaryOutcomes measure: Percent of time spent with glucose level above 180 mg/dl, secondaryOutcomes measure: Percent of time spent with glucose level above 250 mg/dl, secondaryOutcomes measure: Coefficient of glucose variability, secondaryOutcomes measure: Score of PAID questionnaire for parents, secondaryOutcomes measure: Score of PAID questionnaire for children, secondaryOutcomes measure: Stimulated plasma C-peptide level 10-min after 1mg IV glucagon, secondaryOutcomes measure: Number of needed interventions by the parents/guardians or care providers, otherOutcomes measure: Change of HbA1c level between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent in the 70-180 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent in the 70-140 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of mean glucose level between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent with glucose level below 70 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent with glucose level below 54 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent with glucose level above 180 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent with glucose level above 250 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of coefficient of glucose variability between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of score of PAID questionnaire for parents between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of score of PAID questionnaire for children between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of stimulated plasma C-peptide level 10-min after 1mg IV glucagon between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of number of needed interventions by the parents/guardians or care providers between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Difference in the HbA1c level between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent in the 70-180 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent in the 70-140 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the mean glucose level between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent with glucose level below 70 mg/dl between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent with glucose level below 54 mg/dl between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent with glucose level above 180 mg/dl between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent with glucose level above 250 mg/dl between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the coefficient of glucose variability between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the score of PAID questionnaire for parents between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the score of PAID questionnaire for children between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the stimulated plasma C-peptide level 10-min after 1mg IV glucagon between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the number of needed interventions by the parents/guardians or care providers between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Incidence of treatment-emergent SUSARs, SAEs, ARs and AEs, otherOutcomes measure: Relatedness of treatment-emergent SUSARs, SAEs, ARs and AEs, otherOutcomes measure: Severity of treatment-emergent SUSARs, SAEs, ARs and AEs, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University Hospital, Angers, city: Angers, country: France, contacts name: Régis Coutant, MD, role: CONTACT, phone: 02 41 35 56 55, phoneExt: +33, email: recoutant@chu-angers.fr, geoPoint lat: 47.46667, lon: -0.55, locations facility: University Hospital, Montpellier, city: Montpellier, country: France, contacts name: Eric Renard, MD, role: CONTACT, phone: 04 67 33 83 82, phoneExt: +33, email: e-renard@chu-montpellier.fr, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Robert Debré Hospital, AP-HP, city: Paris, country: France, contacts name: Elise Bismuth Reisman, MD, role: CONTACT, phone: 01 40 03 20 67, phoneExt: +33, email: elise.bismuth@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: University Hospital, Tours, city: Tours, country: France, contacts name: Yannis Chartier, MD, role: CONTACT, phone: 06 85 67 93 35, phoneExt: +33, email: Y.CHARTIER@chu-tours.fr, geoPoint lat: 47.38333, lon: 0.68333, hasResults: False