Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT03411460
Status:
TERMINATED
Last Update Posted:
2018-01-26
First Post:
2017-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'logistical difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-25', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction of patient-determined hospital care at discharge in the two groups', 'timeFrame': 'at discharge from hospital; maximum Day 5', 'description': 'visual analogue scale 0-10'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction concerning treatment for their diabetes', 'timeFrame': 'at discharge from hospital; maximum Day 5', 'description': 'Diabetes Treatment Satisfaction Questionnaire'}, {'measure': 'Patient quality of sleep', 'timeFrame': 'at each day of hospitalization and discharge; maximum Day 5', 'description': 'Spiegel questionnaire'}, {'measure': 'Satisfaction of nursing staff concerning care of patient', 'timeFrame': 'at end of study; maximum Day 5', 'description': 'visual analogue scale response to 5 quesions'}, {'measure': 'Time taken by nurse to measure circulating glucose level', 'timeFrame': 'Daily over length of hospitalization until maximum Day 5', 'description': 'in minutes'}, {'measure': 'Time necessary to achieve satisfactory equilibrium using insulin pump', 'timeFrame': 'maximum Day 5', 'description': 'average daily glucose level \\< 1.50 g/l'}, {'measure': 'Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay', 'timeFrame': 'maximum Day 5'}, {'measure': 'Number of hypoglycmic events with the corresponding glucose level', 'timeFrame': 'maximum Day 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin-Dependent Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has given their free and informed consent\n* The patient must be insured or the beneficiary of an insurance policy\n* The patient is aged at least 18 years and less than 75 years old.\n* Patients have a BMI between 18 and 40kg/m2\n* Diabetic patient admitted for glycemic instability with indication for treatment using an external insulin pump but otherwise in a stable clinical state\n\nExclusion Criteria:\n\n* The subject is participating in another study\n* The subject is in an exclusion period determined by a previous study\n* The patients is under judicial protection or state guardianship\n* The subject refuses to sign the consent form\n* It proves impossible to give the subject clear information.\n* The patient is pregnant, parturient or breastfeeding\n* The patient is clinically unstable\n* BMI less than 18 or over 40\n* Existence of a severe rapidly progressive ischemic retinopathy or proliferative retinopathy.\n* Serious psychiatric problems\n* Chronic cutaneous infection'}, 'identificationModule': {'nctId': 'NCT03411460', 'acronym': 'GLUCO FLASH', 'briefTitle': 'Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Satisfaction of Using a Continuous Glucose Monitoring System to Monitor Interstitial Fluid Glucose Level in Hospitalized Insulin-dependent Diabetic Patients Treated Using a Portable Sub-cutaneous Pump', 'orgStudyIdInfo': {'id': 'LOCAL/2016/MR-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interstitial glucose', 'description': 'Glucose level tested by continuous monitoring device', 'interventionNames': ['Device: FreeStyle Libre™ system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blood glucose', 'description': 'Glucose level tested on glucose monitor using standard finger prick', 'interventionNames': ['Procedure: Finger prick']}], 'interventions': [{'name': 'FreeStyle Libre™ system', 'type': 'DEVICE', 'description': 'Measured non-invasively via scanner', 'armGroupLabels': ['Interstitial glucose']}, {'name': 'Finger prick', 'type': 'PROCEDURE', 'description': 'Blood test', 'armGroupLabels': ['Blood glucose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}