Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-06 @ 10:01 AM
Study NCT ID:
NCT03653533
Status:
TERMINATED
Last Update Posted:
2020-07-10
First Post:
2018-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Difficulties for recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function', 'timeFrame': '6 days', 'description': 'The primary outcome is the area between the glycemic curve and the hypoglycemic level (70 mg/dL), measured between the 6 last days of the phase without SmartGuard® function and the 6 last days with the use of SmartGuard® function'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type I Diabetes']}, 'descriptionModule': {'briefSummary': 'This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.', 'detailedDescription': 'The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition.\n\nThere are several phases:\n\n* phase 1: insulin pump without captor (12 weeks)\n* phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks)\n* phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks)\n* phase 4: insulin pump without captor (4 weeks)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type I diabetic patients undr basal/prandial diet\n* treated by insuline\n* with no insuline pump during at least 3 months\n* with HbA1C dosed during the 3 months before inclusion\n\nExclusion Criteria:\n\n* minor patients\n* pregnant woman\n* already participating to another studies'}, 'identificationModule': {'nctId': 'NCT03653533', 'acronym': 'AAHPI', 'briefTitle': 'Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump', 'organization': {'class': 'OTHER', 'fullName': 'ARAIR Assistance'}, 'officialTitle': 'Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults', 'orgStudyIdInfo': {'id': '2017-A01988-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MiniMed™ 640G alone', 'description': 'MiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.', 'interventionNames': ['Device: MiniMed™ 640G']}, {'type': 'OTHER', 'label': 'MiniMed™ 640G + Captor CGM Enlite®', 'description': 'insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.', 'interventionNames': ['Device: MiniMed™ 640G', 'Device: Captor CGM Enlite®']}, {'type': 'OTHER', 'label': 'MiniMed™ 640G + Captor + SmartGuard®', 'description': 'insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.', 'interventionNames': ['Device: MiniMed™ 640G', 'Device: Captor CGM Enlite®', 'Device: SmartGuard®']}], 'interventions': [{'name': 'MiniMed™ 640G', 'type': 'DEVICE', 'description': 'The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin', 'armGroupLabels': ['MiniMed™ 640G + Captor + SmartGuard®', 'MiniMed™ 640G + Captor CGM Enlite®', 'MiniMed™ 640G alone']}, {'name': 'Captor CGM Enlite®', 'type': 'DEVICE', 'description': 'The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level', 'armGroupLabels': ['MiniMed™ 640G + Captor + SmartGuard®', 'MiniMed™ 640G + Captor CGM Enlite®']}, {'name': 'SmartGuard®', 'type': 'DEVICE', 'description': 'This SmartGuard® function is used to improve the glycemia stability in real condition', 'armGroupLabels': ['MiniMed™ 640G + Captor + SmartGuard®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Le Mans', 'country': 'France', 'facility': 'Pole Sante Sud Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARAIR Assistance', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}