Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-08 @ 6:58 PM
Study NCT ID:
NCT03300934
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2017-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-29', 'studyFirstSubmitDate': '2017-09-29', 'studyFirstSubmitQcDate': '2017-09-29', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time spent in glucose target (%) (3.9 - 10 mmol/l)', 'timeFrame': '4 week treatment arms', 'description': 'Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison.'}], 'secondaryOutcomes': [{'measure': 'Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l)', 'timeFrame': '4 week treatment arms', 'description': 'Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)'}, {'measure': 'Time spent above glucose target (%) (> 10 mmol/l)', 'timeFrame': '4 week treatment arms', 'description': 'Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)'}, {'measure': 'Severe hypoglycaemic events', 'timeFrame': '4 week treatment arms', 'description': 'ISPAD Definition of severe hypoglycemia'}, {'measure': 'Severe Diabetes ketoacidosis', 'timeFrame': '4 week treatment arms', 'description': 'ISPAD definition of severe DKA'}, {'measure': 'Use of the automated closed loop system (% time)', 'timeFrame': '4 week treatment arm', 'description': '% time , the system is used'}, {'measure': 'Use of the CGM during closed loop', 'timeFrame': '4 week treatment arm', 'description': '% time , the system is used'}, {'measure': 'Quality of life perception in adolescents', 'timeFrame': '4 week treatment periods', 'description': 'Questionnaire based'}, {'measure': 'Family Responsibility perception', 'timeFrame': '4 week treatment periods', 'description': 'Questionnaire based : Family responsibility scale'}, {'measure': 'User experience after the 4 week treatment', 'timeFrame': '4 week intervention', 'description': 'questionnaire based'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep', 'detailedDescription': 'Achievement of a good metabolic control is very important for all persons with diabetes . In adolescence many changes occur , physically , socially and psychologically .This may influence the metabolic control . This study will evaluate whether the automated closed-loop will facilitate and improve the management of diabetes in youth with a poor metabolic control.\n\nIt is a single-centre, randomised, two-period crossover study to assess the efficacy /safety and acceptability of the automated closed-loop glucose control (CL) day and night, over 28 days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting in poorly controlled type 1 diabetes adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient and parents\n\nExclusion Criteria:\n\nNon-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.\n\nCurrent treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator Known or suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by ISPAD guidelines during the previous 12 months.\n\nMore than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12 months\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03300934', 'acronym': 'SPIDIMAN2', 'briefTitle': 'Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier du Luxembourg'}, 'officialTitle': 'Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?', 'orgStudyIdInfo': {'id': 'Spidiman'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'closed loop glucose control system', 'description': 'Closed loop glucose control system', 'interventionNames': ['Device: closed loop glucose control system']}, {'type': 'NO_INTERVENTION', 'label': 'CSII Pump treatment', 'description': 'CSII Pump treatment without the integrated algorithm and glucose sensor'}], 'interventions': [{'name': 'closed loop glucose control system', 'type': 'DEVICE', 'description': 'Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment', 'armGroupLabels': ['closed loop glucose control system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1210', 'city': 'Luxembourg', 'country': 'Luxembourg', 'facility': 'Clinique des Enfants CHluxembourg', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}], 'overallOfficials': [{'name': 'Carine de Beaufort, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier du Luxembourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier du Luxembourg', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cambridge', 'class': 'OTHER'}, {'name': 'Luxembourg Institute of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Guest professor', 'investigatorFullName': 'Carine de Beaufort', 'investigatorAffiliation': 'Centre Hospitalier du Luxembourg'}}}}