Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT03296995
Status:
UNKNOWN
Last Update Posted:
2017-09-29
First Post:
2017-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy, Feasibility and Acceptance of CGM Lupus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Technical problems with the monitoring', 'timeFrame': '7 d', 'description': 'Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.'}], 'primaryOutcomes': [{'measure': 'Accuracy of continuous glucose monitoring compared to glucose oxidase method', 'timeFrame': '7 d', 'description': 'Difference between glucose values of continuous glucose monitoring and blood gas analyses'}], 'secondaryOutcomes': [{'measure': 'Feasibility of continuous glucose monitoring', 'timeFrame': '7 d', 'description': 'Problems within the application of sensor and monitoring during ward routine'}, {'measure': 'Acceptance of continuous glucose monitoring by physicians and nursing staff', 'timeFrame': '7 d', 'description': 'Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucose', 'systemic lupus erythematosus'], 'conditions': ['Systemic Lupus Erythematosus', 'Critical Illness', 'Diabetic Blood Glucose Monitoring']}, 'descriptionModule': {'briefSummary': 'This is a prospective monocenter, non-randomised, open-lable single-group intervention diagnostic trial on the accuracy, reliability and feasibility of the continuous glucose monitoring system in critically systemic lupus erythematosus (SLE). Newly developed technologies for continuous glucose monitoring in critically SLE patients may improve glycemic control and reduce glucose variability. Critically SLE patients will be performed by continuous glucose monitoring. The subcutaneous glucose will be continuously monitored in critical SLE patients by freestyle libre glucose monitoring system for 14 days. The aim of this study is to evaluate accuracy feasibility and acceptance of these methods. To analyze accuracy sensor glucose levels will be validated due to venous blood measurements with glucose oxidase methods. The influence of several factors like oedema, perspiration, BMI, body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the particular system would be evaluated. Furthermore the acceptance of physicians and Nursing staff would be evaluated by a questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;\n* critically SLE patients\n* informed consent by the patients or legal proxy\n\nExclusion Criteria:\n\n* age \\< 18\n* no informed consent by the patients or legal proxy\n* pregnancy\n* infaust prognosis"}, 'identificationModule': {'nctId': 'NCT03296995', 'briefTitle': 'Accuracy, Feasibility and Acceptance of CGM Lupus', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'SHRJ001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'flash glucose monitoring system', 'description': 'Subjects in the arm measure blood glucose by flash glucose monitoring system.', 'interventionNames': ['Device: Flash glucose monitoring system']}], 'interventions': [{'name': 'Flash glucose monitoring system', 'type': 'DEVICE', 'description': 'Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.', 'armGroupLabels': ['flash glucose monitoring system']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuang Ye, MD', 'role': 'CONTACT', 'email': 'ye_shuang2000@163.com', 'phone': '+8613817615871'}, {'name': 'Huijing Wang, postgraduate', 'role': 'CONTACT', 'email': 'whj30813@163.com', 'phone': '+8618267851823'}], 'facility': 'Shuang Ye, MD', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}