Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:31 PM
Study NCT ID:
NCT07317102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the percentage of time in the 70 - 180 mg/dL range', 'timeFrame': 'Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}], 'secondaryOutcomes': [{'measure': 'Percentage of time in the 70 - 180 mg/dL range', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Percentage of time in the 70 - 140 mg/dL range', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Percentage of time below 54 mg/dL', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Percentage of time below 70 mg/dL', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Percentage of time above 180 mg/dL', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Percentage of time above 250 mg/dL', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Glucose Management Indicator (GMI)', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Glycemic Risk Index (GRI)', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Coefficient of variation (CV)', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'Mean glucose', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Glucose metric from continuous glucose monitoring system to assess glucose control'}, {'measure': 'HbA1c Level (if available)', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Blood test to assess glucose control'}, {'measure': 'Percentage of patients with ≥ 70%', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Assess the achievement of CGM-based consensus targets'}, {'measure': 'Percentage of patients with < 4%', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Assess the achievement of CGM-based consensus targets'}, {'measure': 'Percentage of patients with < 1%', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Assess the achievement of CGM-based consensus targets'}, {'measure': 'Percentage of patients with GMI ≤ 7%', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Assess the achievement of CGM-based consensus targets'}, {'measure': 'Percentage of patients with CV ≤ 36%', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Assess the achievement of CGM-based consensus targets'}, {'measure': 'Percentage of patients achieving combinations of previous CGM-based consensus targets', 'timeFrame': 'Up to 12-months following first initiation of automated mode', 'description': 'Assess the achievement of CGM-based consensus targets'}, {'measure': 'EuroQoL 5-dimension 5-level questionnaire', 'timeFrame': 'At inclusion and 6 and 12 months following first initiation of automated mode', 'description': "Assess patients' general quality of life"}, {'measure': 'Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory', 'timeFrame': 'At inclusion and 6 and 12 months following first initiation of automated mode', 'description': "Assess patients' diabetes-specific quality of life"}, {'measure': 'Patients aged 10-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)', 'timeFrame': 'At inclusion and 6 and 12 months following first initiation of automated mode', 'description': "Assess patients' diabetes-specific quality of life"}, {'measure': 'Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score', 'timeFrame': 'At inclusion and 6 and 12 months following first initiation of automated mode', 'description': "Assess the interference of the Omnipod 5 System with patients' daily lives"}, {'measure': 'Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version(DTSQs)', 'timeFrame': 'At inclusion and 6 and 12 months following first initiation of automated mode', 'description': "Assess patients' satisfaction with the Omnipod 5 System"}, {'measure': 'Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire, status version -Teens (DTSQs - Teen)', 'timeFrame': 'At inclusion and 6 and 12 months following first initiation of automated mode', 'description': "Assess patients' satisfaction with the Omnipod 5 System"}, {'measure': 'Patients aged 2-12 years: Diabetes Treatment Satisfaction Questionnaire, status version -Parent (DTSQs - Parent)', 'timeFrame': 'At inclusion and 6 and 12 months following first initiation of automated mode', 'description': "Assess patients' satisfaction with the Omnipod 5 System"}, {'measure': 'Pediatric quality of life questionnaire (animated emoji scale - ad hoc)', 'timeFrame': 'At inclusion and 6 and 12 months following first initiation of automated mode', 'description': "Assess pediatric patients' quality of life with the Omnipod 5 System"}, {'measure': 'Percentage of time using the System in automated mode', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Describe System use'}, {'measure': 'Percentage of time using the System in manual mode', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Describe System use'}, {'measure': 'Percentage of time using "Activity" feature', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Describe System use'}, {'measure': 'Total daily dose of insulin', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Describe System use'}, {'measure': 'Number of boluses per day', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Describe System use'}, {'measure': 'Targets used by patients', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Describe System use'}, {'measure': 'Bolus/Basal distribution', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Describe System use'}, {'measure': 'Incidence of severe hypoglycemia', 'timeFrame': '6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode', 'description': 'Assess the incidence and type of acute metabolic complications'}, {'measure': 'Incidence of diabetic ketoacidosis', 'timeFrame': '6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode', 'description': 'Assess the incidence and type of acute metabolic complications'}, {'measure': 'Unscheduled hospitalizations for diabetes or diabetes complications', 'timeFrame': '6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode', 'description': 'Assess the incidence and type of acute metabolic complications'}, {'measure': 'Percentage of patients still using the Omnipod 5 System at the end of study follow-up', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Assess the rate at which patients stop using the Omnipod 5 system'}, {'measure': 'Reasons for having stopped using the Omnipod 5 System', 'timeFrame': '12 months following first initiation of automated mode', 'description': 'Assess the rate at which patients stop using the Omnipod 5 system'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Omnipod', 'Automated Insulin Delivery', 'Post-market Registry'], 'conditions': ['Diabetes', 'Type 1 Diabetes', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.', 'detailedDescription': 'Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed the commercially available FreeStyle Libre 2 Plus configuration of the Omnipod 5 Automated Insulin Delivery System in France.\n\nOPTIMAL-B study (Omnipod 5 - A French Prospective Multicentric Study in Real World), aims to provide the requisite real-world data on the glycemic control, quality of life, safety, and device usage profiles of users of the Omnipod 5 System during the 12 months after starting using Omnipod 5 in automated mode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population contains patients (age ≥ 2 years) with T1DM initiating a commercially available configuration of the Omnipod 5 System using a FreeStyle Libre 2Plus in France.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with T1D aged ≥ 2 years.\n* Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.\n* Patient has never used the Omnipod 5 System prior to inclusion.\n* Patient has not objected to the use of their personal data for this study.\n* Patient or legal guardian has an email address and mobile phone number.\n* Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.\n* Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.\n* Patient is covered by the local social security system\n\nExclusion Criteria:\n\n* Patient is currently pregnant.\n* Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).\n* Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.\n* Patient is already participating in a clinical trial or in another study precluding their participation in other studies.\n* Adult under guardianship, curatorship or tutorship.\n* Adult otherwise deprived of liberty.'}, 'identificationModule': {'nctId': 'NCT07317102', 'briefTitle': 'Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Insulet Corporation'}, 'officialTitle': 'Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)', 'orgStudyIdInfo': {'id': 'Optimal-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Omnipod 5 User', 'description': 'Participation of each patient begins at inclusion and continues until the end-of-study visit, 12 months (± 1 month) following first initiation of automated mode of the Omnipod 5 System', 'interventionNames': ['Device: Omnipod 5']}], 'interventions': [{'name': 'Omnipod 5', 'type': 'DEVICE', 'description': 'The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin.\n\nThe Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.', 'armGroupLabels': ['Omnipod 5 User']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Lucie DUFOUR', 'role': 'CONTACT'}, {'name': 'Regis COUTANT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'contacts': [{'name': 'Julie GUCCIARDI', 'role': 'CONTACT'}, {'name': 'Sophie BOROT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Besançon - Hôpital de Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'contacts': [{'name': 'Sarah YAHIAOUI', 'role': 'CONTACT'}, {'name': 'Emmanuel COSSON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP Hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Caroline BOUYSSOU', 'role': 'CONTACT'}, {'name': 'Sandra POCHELU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux - Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Bogdan CATARGI', 'role': 'CONTACT'}, {'name': 'Bogdan CATARGI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux - Hôpital St-André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Pascale Quiniou', 'role': 'CONTACT'}, {'name': 'Emmanuel SONNET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Brest - Hôpital de la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '39500', 'city': 'Bron', 'country': 'France', 'contacts': [{'name': 'Karima RENDJA', 'role': 'CONTACT'}, {'name': 'Kevin PERGE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '91100', 'city': 'Corbeil-Essonnes', 'country': 'France', 'contacts': [{'name': 'Catherine PETIT', 'role': 'CONTACT'}, {'name': 'Alfred PENFORNIS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Sylvie PICARD', 'role': 'CONTACT'}, {'name': 'Sylvie PICARD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CIRDIA', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Isabelle SIMONEAU', 'role': 'CONTACT'}, {'name': 'Bruno VERGES', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Dijon - Hôpital François Mitterrand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'contacts': [{'name': 'Harivola ANDRIANTAOLO', 'role': 'CONTACT'}, {'name': 'Didier GOUET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GH La Rochelle-Ré-Aunis - Hôpital Saint Louis', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'contacts': [{'name': 'Marie-Agathe TROUVIN', 'role': 'CONTACT'}, {'name': 'Marie-Agathe TROUVIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '28300', 'city': 'Mainvilliers', 'country': 'France', 'contacts': [{'name': 'Eva BRIAND', 'role': 'CONTACT'}, {'name': 'Said BEKKA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de Diabétologie et de Nutrition du Centre', 'geoPoint': {'lat': 48.45003, 'lon': 1.45607}}, {'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Audrey OLIVETTI', 'role': 'CONTACT'}, {'name': 'Pauline SCHAEPELYNCK', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondation Ambroise Paré - Hôpital Européen de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'contacts': [{'name': 'Manal AL MASRI-SHBAT', 'role': 'CONTACT'}, {'name': 'Eric RENARD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Montpellier - Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34250', 'city': 'Palavas-les-Flots', 'country': 'France', 'contacts': [{'name': 'Chrystel LEPERCHOIS', 'role': 'CONTACT'}, {'name': 'Fabienne DALLA VALE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Saint Pierre', 'geoPoint': {'lat': 43.52974, 'lon': 3.93043}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Charline POTIER', 'role': 'CONTACT'}, {'name': 'Jean-Pierre RIVELINE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Caroline ARNAUD-SARTHOU', 'role': 'CONTACT'}, {'name': 'Elise BISMUTH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP Hopital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '24000', 'city': 'Périgueux', 'country': 'France', 'contacts': [{'name': 'Aude ANGELESCU', 'role': 'CONTACT'}, {'name': 'Christine COFFIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Périgueux', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '34430', 'city': 'Saint-Jean-de-Védas', 'country': 'France', 'contacts': [{'name': 'Mérédith MERCIER', 'role': 'CONTACT'}, {'name': 'Elizabeth BONNEMAISON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Saint Jean de Védas', 'geoPoint': {'lat': 43.57759, 'lon': 3.82603}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Samir CHENAF', 'role': 'CONTACT'}, {'name': 'Nathalie JEANDIDIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Sophie GOUNIN', 'role': 'CONTACT'}, {'name': 'Yannis CHARTIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Trang Ly, MBBS, PhD', 'role': 'CONTACT', 'email': 'APClinical@insulet.com', 'phone': '978-600-7000'}, {'name': 'Bonnie Dumais', 'role': 'CONTACT', 'email': 'APClinical@insulet.com', 'phone': '978-600-7000'}], 'overallOfficials': [{'name': 'Jean-Pierre Riveline, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Universitaire du Diabète et ses complications Hôpital Lariboisière'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insulet Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}