protocolSection identificationModule nctId: NCT06363916, orgStudyIdInfo id: 2023-A00335-40, briefTitle: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System, acronym: SEECLOOP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Medtrum France, class: INDUSTRY, collaborators name: Axonal-Biostatem, descriptionModule briefSummary: The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.The main question it aims to answer is :• Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?Participants will be :* Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system* Randomized to the Open Loop or Closed Loop group* Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire statusResearchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group., conditionsModule conditions: Type 1 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Insulin Management System in Manual mode of operation, interventions name: Insulin Management System in Automatic mode of operation, outcomesModule primaryOutcomes measure: Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups, secondaryOutcomes measure: Evolution of TIR, secondaryOutcomes measure: Evolution of coefficient of glycemic variation, secondaryOutcomes measure: Superiority in Glycated Haemoglobin (HbA1c) improvement, secondaryOutcomes measure: Evolution of Time spent Above Range (TAR), secondaryOutcomes measure: Evolution of Time spent Below Range (TBR), secondaryOutcomes measure: Body Mass Index change, secondaryOutcomes measure: Glucose sensor measurement change, secondaryOutcomes measure: Percentage of patients with TIR > 70%, secondaryOutcomes measure: Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1%, secondaryOutcomes measure: Evolution of glucose management indicator (GMI), secondaryOutcomes measure: Evolution of dosage of insulin, secondaryOutcomes measure: Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop), secondaryOutcomes measure: Evolution of Self-administered Questionnaires scores, secondaryOutcomes measure: Evolution of Diabetes Treatment Satisfaction score, secondaryOutcomes measure: Safety Events, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TBR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on GMI, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on dosage of insulin, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on Self-administered Questionnaires scores, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Angers, city: Angers, country: France, contacts name: Regis COUTANT, role: CONTACT, contacts name: Regis COUTANT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU Besançon, city: Besançon, country: France, contacts name: Sophie BOROT, role: CONTACT, contacts name: Sophie BOROT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Bordeaux, city: Bordeaux, country: France, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Caen, city: Caen, country: France, contacts name: Michael JOUBERT, role: CONTACT, contacts name: Michael JOUBERT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Centre Hospitalier Sud-Francilien, city: Corbeil-Essonnes, country: France, contacts name: Freddy PENFORNIS, role: CONTACT, contacts name: Freddy PENFORNIS, role: PRINCIPAL_INVESTIGATOR, contacts name: Thanh-Lan DANG DUY, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.60603, lon: 2.48757, locations facility: Centre Hospitalier de Gonesse, city: Gonesse, country: France, contacts name: Jennifer ALLAIN, role: CONTACT, contacts name: Jennifer ALLAIN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.98693, lon: 2.44892, locations facility: Centre Hospitalier Saint-Louis, city: La Rochelle, country: France, contacts name: Didier GOUET, role: CONTACT, contacts name: Didier GOUET, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.16667, lon: -1.15, locations facility: Hôpital Hôtel-Dieu, city: Le Creusot, country: France, contacts name: Sylvaine CLAVEL, role: CONTACT, contacts name: Sylvaine CLAVEL, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.80714, lon: 4.41632, locations facility: Hospices Civils de Lyon, city: Lyon, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital Européen, city: Marseille, country: France, contacts name: Denis RACCAH, role: CONTACT, contacts name: Denis RACCAH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Hôpital La Timone, city: Marseille, country: France, contacts name: Rachel REYNAUD, role: CONTACT, contacts name: Rachel REYNAUD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CHU Montpellier, city: Montpellier, country: France, contacts name: Fabienne DALLA VALE, role: CONTACT, contacts name: Fabienne DALLA VALE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: CHU Nantes, city: Nantes, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Hôpital Lariboisière, city: Paris, country: France, contacts name: Jean-Pierre RIVELINE, role: CONTACT, contacts name: Jean-Pierre RIVELINE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Necker, city: Paris, country: France, contacts name: Jacques BELTRAND, role: CONTACT, contacts name: Jacques BELTRAND, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Robert Debré, city: Paris, country: France, contacts name: Elise BISMUTH, role: CONTACT, contacts name: Elise BISMUTH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Rangueil, city: Toulouse, country: France, contacts name: Vincent MELKI, role: CONTACT, contacts name: Vincent MELKI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False