Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT06382350
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-02', 'studyFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Analysis of glycemia', 'timeFrame': '10 days of CGM measurement', 'description': 'This outcome evaluates the mean glycemia and glycemia variability (SD) during the periods of driving and compares them with the same compared with the same variables obtained during the non-driving periods.'}, {'measure': 'Number of alarms generated by the insulin pump', 'timeFrame': '10 days of CGM measurement', 'description': 'This outcome assesses the frequency of alarms generated by the insulin pump during preriods of driving and compares them ther same variable generated in non-driving time.'}, {'measure': 'Insulin dosing', 'timeFrame': '10 days of CGM measurement', 'description': 'This is to assess the insulin dosing (insulin units/minute) during driving and compare them with the same variable in non-driving time.'}, {'measure': 'Food intake', 'timeFrame': '10 days of CGM measurement', 'description': 'This is to assess the food intake (frequency of food intake) while driving and compare them with non-driving time.'}, {'measure': 'Glycemia during the periods of sleep', 'timeFrame': '10 days of CGM measurement', 'description': 'The outcome evaluates glycemia (mmol/l) during a night sleep.'}, {'measure': 'Glycemia during the periods of occupation', 'timeFrame': '10 days of CGM measurement', 'description': 'The outcome evaluates glycemia (mmol/l) during periods of occupation.'}, {'measure': 'Glycemia during the periods of physical activity', 'timeFrame': '10 days of CGM measurement', 'description': 'The outcome evaluates glycemia (mmol/l) during the periods of physical activity.'}, {'measure': 'Glycemia during the periods of stress', 'timeFrame': '10 days of CGM measurement', 'description': 'The outcome evaluates glycemia (mmol/l) during the periods of stress.'}], 'primaryOutcomes': [{'measure': 'The frequency of hypoglycemia during the driving periods', 'timeFrame': '10 days of CGM measurement', 'description': 'This outcome evaluates the number of hypoglycemic events (drop of glycemia \\<3.9 mmol/l) during the driving periods.'}], 'secondaryOutcomes': [{'measure': 'Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods.', 'timeFrame': '10 days of CGM measurement', 'description': 'The outcome evaluates the amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during driving.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 1 diabetes mellitus', 'Driving', 'Closed-loop system'], 'conditions': ['Type 1 Diabetes Mellitus', 'Type 1 Diabetes Mellitus With Hypoglycemia', 'Drive']}, 'descriptionModule': {'briefSummary': 'The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy', 'detailedDescription': 'This national multi-center prospective observational controlled study focuses on the safety of insulin pump closed-loop in patients over 18 with type 1 diabetes while driving. A total of 100 patients (treated with MiniMed 780 G + CGM) will be enrolled in the study group and 20 patients in the control group (treated by multiple daily injections (MDI) + CGM) at 10-20 study centers.\n\nAfter the inclusion and exclusion criteria evaluation and informed consent signing, each patient receives the Patient Diary. The diary will be used to record the times of observed events during the study period lasting ten days: periods of driving (from-to), periods of night sleep, periods of occupation, periods of physical activity, periods of stress (self-defined), an extra dose of insulin not covered by carbohydrates, an extra dose of carbohydrates not covered by insulin (more variables are required to hide a little bit the primary target of the study).\n\nCGM data obtained during the study period will also be downloaded at the end of the study period.\n\nFinally, the data from the CGM and the patient diary will be compared and analyzed, especially regarding the course of glycemia during driving and the presence of hypoglycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 diabetes patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\nStudy group:\n\n* type 1 diabetes\n* patients aged ≥18 year\n* diabetes duration ≥3 years\n* regularly driving (non-professional drivers only)\n* treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment\n* willing to fill in the study questionnaires\n* signed patient's informed consent form\n\nControl group:\n\n* type 1 diabetes\n* patients aged ≥18 years\n* diabetes duration ≥3 years\n* regularly driving (non-professional drivers only)\n* treatment with multiple daily injections (MDI) of insulin therapy and the use of CGM for at least 6 months\n* willing to fill in the study questionnaires\n* signed patient's informed consent form\n\nExclusion Criteria (for study and control groups)\n\n* professional drivers\n* pregnancy\n* inability to be present at the follow-up visit\n* inability to complete the study questionnaires\n* participation in another clinical study within the last 3 months"}, 'identificationModule': {'nctId': 'NCT06382350', 'acronym': 'SAFEDRIVE', 'briefTitle': 'Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Motol'}, 'officialTitle': 'Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems (Insulin Pump and Continuous Glucose Monitor) Versus Conventional Treatment in Different Life Situations - an Observational Multicenter Study', 'orgStudyIdInfo': {'id': 'KHL-002-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring)', 'interventionNames': ['Device: MiniMed 780 G']}, {'label': 'Control group', 'description': 'Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM'}], 'interventions': [{'name': 'MiniMed 780 G', 'type': 'DEVICE', 'description': 'none, observational study', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Eva Al Jamal, Mgr.', 'role': 'CONTACT', 'email': 'eva.aljamal@fnmotol.cz', 'phone': '224 431 017', 'phoneExt': '+420'}, {'name': 'Veronika Šourková', 'role': 'CONTACT', 'email': 'veronika.sourkova@fnmotol.cz', 'phone': '224 431 004', 'phoneExt': '+420'}, {'name': 'Pavlina Krollova, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UH Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Eva Al Jamal, Mgr.', 'role': 'CONTACT', 'email': 'eva.aljamal@fnmotol.cz', 'phone': '224 431 017', 'phoneExt': '+420'}, {'name': 'Veronika Šourková', 'role': 'CONTACT', 'email': 'veronika.sourkova@fnmotol.cz', 'phone': '224 431 004', 'phoneExt': '+420'}], 'overallOfficials': [{'name': 'Jan Brož, MUDr., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Medical Faculty, Charles University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Motol', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jan Broz', 'investigatorAffiliation': 'University Hospital, Motol'}}}}