Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-21 @ 5:41 PM
Study NCT ID:
NCT03103867
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2017-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QUality of Control and slEep in Children With diabeteS, Using New Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-15', 'mcpReleaseN': 2, 'releaseDate': '2022-02-23'}], 'estimatedResultsFirstSubmitDate': '2022-02-23'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2017-03-26', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in glucose target', 'timeFrame': 'Last 6 days of treatment arm A and last 6 days of treatment arm B', 'description': 'Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM'}], 'secondaryOutcomes': [{'measure': 'time below glucose target', 'timeFrame': 'Last 6 days of treatment arm A and last 6 days of treatment arm B', 'description': 'Percent time spent below glucose target (\\<3.0mmol/l and \\< 2,5 mmol/l) measured by blinded CGM (I-Pro 2)'}, {'measure': 'Time above glucose target', 'timeFrame': 'Last 6 days of treatment arm A and last 6 days of treatment arm B', 'description': 'Percent time spent above glucose target (\\>10.0mmol/l ) measured by blinded CGM (I-Pro 2)'}, {'measure': 'Sleep quantity in patients and caregivers', 'timeFrame': 'baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B', 'description': 'Total sleep and wake time , number of awakenings measured by wireless actigraph'}, {'measure': 'perception of quality of sleep and quality of life in patients and caregivers', 'timeFrame': 'baseline and last week of treatment arm A and last week of treatment arm B', 'description': 'validated questionnaires'}, {'measure': 'hypoglycaemia fear in patients and caregivers', 'timeFrame': 'baseline and last week of treatment arm A and last week of treatment arm B', 'description': 'Hypoglycemia fear survey for parents and children'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '39736868', 'type': 'DERIVED', 'citation': 'Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Schritz A, Vaillant M, Barnard-Kelly K, Cohen O, Gies I, de Beaufort C. Fear of hypoglycemia and sleep in children with type 1 diabetes and their parents. Front Endocrinol (Lausanne). 2024 Dec 16;15:1419502. doi: 10.3389/fendo.2024.1419502. eCollection 2024.'}, {'pmid': '35712259', 'type': 'DERIVED', 'citation': 'Schierloh U, Aguayo GA, Schritz A, Fichelle M, De Melo Dias C, Vaillant MT, Cohen O, Gies I, de Beaufort C. Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 May 31;13:870916. doi: 10.3389/fendo.2022.870916. eCollection 2022.'}, {'pmid': '30509293', 'type': 'DERIVED', 'citation': 'Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Celebic A, Vaillant M, Barnard K, Cohen O, de Beaufort C. Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study. Trials. 2018 Dec 4;19(1):665. doi: 10.1186/s13063-018-3034-4.'}]}, 'descriptionModule': {'briefSummary': "The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.", 'detailedDescription': "Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of children with T1DM, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. This leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes.\n\nIn this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or without impact on insulin administration and without alerts."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes\n* Duration of diabetes ≥ 6 months\n* Insulin pump treatment ≥ 6 months\n* HbA1c ≤ 11%\n* Parental written informed consent\n\nExclusion Criteria:\n\n. No parental consent\n\n* Physical or psychological disease likely to interfere with an appropriate conduct of the study\n* Current drug therapy knowing to interfere with glucose metabolism\n* Chronic sleep medication in the primary caregiver or the patient -'}, 'identificationModule': {'nctId': 'NCT03103867', 'acronym': 'QUEST', 'briefTitle': 'QUality of Control and slEep in Children With diabeteS, Using New Technology', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier du Luxembourg'}, 'officialTitle': 'Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children With Type 1 Diabetes and Primary Caregivers.', 'orgStudyIdInfo': {'id': 'QUEST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGM augmented pump with PLGS (A)', 'description': 'Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with integrated continuous glucose monitoring and predicted low glucose suspense (PLGS) Randomised cross over treatment during 5 weeks', 'interventionNames': ['Device: CGM augmented pump with PLGS ,']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin pump with CGM (B)', 'description': 'Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks', 'interventionNames': ['Device: Insulin pump with CGM']}], 'interventions': [{'name': 'CGM augmented pump with PLGS ,', 'type': 'DEVICE', 'otherNames': ['640G, Enlite Sensors , Freestyle Libre'], 'description': '5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration', 'armGroupLabels': ['CGM augmented pump with PLGS (A)']}, {'name': 'Insulin pump with CGM', 'type': 'DEVICE', 'otherNames': ['640G , freestyle libre'], 'description': '5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,', 'armGroupLabels': ['Insulin pump with CGM (B)']}]}, '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': 'STUDY_CHAIR', 'affiliation': 'Centre Hospitalier du Luxembourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier du Luxembourg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Guest Professor , MD, PhD', 'investigatorFullName': 'Carine de Beaufort', 'investigatorAffiliation': 'Centre Hospitalier du Luxembourg'}}}}