Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-01-08 @ 6:55 PM
Study NCT ID:
NCT03352518
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2017-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2017-11-13', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generation and validation of predictive calibration models', 'timeFrame': '3 months', 'description': 'The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed.'}], 'secondaryOutcomes': [{'measure': 'Safety assessment of the intervention by the paucity of adverse events', 'timeFrame': '3 months', 'description': 'The number of subjects experiencing device-related adverse events will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.', 'detailedDescription': 'Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects 18 years of age or older\n* Diabetic patients (all types)\n\nExclusion Criteria:\n\n* Pregnant women\n* Subjects not able to understand and read Danish\n* In investigator's opinion, subject is not able to follow instructions as specified in the protocol\n* Subjects not able to hold hand/arm steadily\n* Extensive skin changes, tattoos or diseases on probe application site\n* Known allergy to medical grade alcohol used to disinfect skin"}, 'identificationModule': {'nctId': 'NCT03352518', 'briefTitle': 'Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'RSP Systems A/S'}, 'officialTitle': 'Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device', 'orgStudyIdInfo': {'id': 'RSP-12-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMD data collection', 'description': 'Subjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators.', 'interventionNames': ['Device: WM3.4NR']}], 'interventions': [{'name': 'WM3.4NR', 'type': 'DEVICE', 'description': 'The investigational medical device will collect spectral raman data from tissue.', 'armGroupLabels': ['IMD data collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Department of Endocrinology M, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jan Erik Henriksen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Odense'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RSP Systems A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}