Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-01 @ 4:11 AM
Study NCT ID:
NCT04021251
Status:
UNKNOWN
Last Update Posted:
2020-08-17
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generation of predictive algorithms for determining blood glucose levels', 'timeFrame': '3 years', 'description': 'Collected spectral raman data will found the development of predictive algorithms for glucose determination.'}, {'measure': 'Validation of predictive algorithms for determining blood glucose levels', 'timeFrame': '3 years', 'description': 'Performance of predictive models will be evaluated using the consensus error grid.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, '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 either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.'}, '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* Skin phototype 1-4\n\nExclusion Criteria:\n\n* For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration\n* For female participants: Breastfeeding\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* Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)\n* Diagnosed with reduced circulation\n* Extensive skin changes, tattoos or diseases on probe application site\n* Known allergy to medical grade alcohol\n* Known allergy to adhesives, applicable to subjects in RSP-16-01\n* Systemic or topical administration of glucocorticoids for the past 7 days and under investigation\n* Participants undergoing dialysis treatment\n* Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate\n* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.\n* Participants currently enrolled in another study"}, 'identificationModule': {'nctId': 'NCT04021251', 'briefTitle': 'Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes', 'organization': {'class': 'INDUSTRY', 'fullName': 'RSP Systems A/S'}, 'officialTitle': 'Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes', 'orgStudyIdInfo': {'id': 'RSP-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short term collection of IMD data', 'description': 'Subjects will collect spectral raman data on P0.2 for minimum 10 hours per day with a maximum of 15 minutes between each measurement for 5 days distributed over a time period of 10 days. Spectral data will be compared to standard BG and/or FGM measurements.', 'interventionNames': ['Device: P0.2']}, {'type': 'EXPERIMENTAL', 'label': 'Medium term collection of IMD data', 'description': 'Subjects will collect spectral raman data on P0.2 for four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements.', 'interventionNames': ['Device: P0.2']}, {'type': 'EXPERIMENTAL', 'label': 'Long term collection of IMD data', 'description': 'Subjects will collect spectral raman data on P0.2 for four times a day for 90 days distributed over a time period of 6 months. Spectral data will be compared to standard BG measurements.', 'interventionNames': ['Device: P0.2']}, {'type': 'EXPERIMENTAL', 'label': 'Medium term collection of IMD data, increased # of sessions', 'description': "Subjects will collect spectral raman data on P0.2 four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. The number of optical sessions performed each time measurements are done are increased compared to the investigation's second arm.", 'interventionNames': ['Device: P0.2']}], 'interventions': [{'name': 'P0.2', 'type': 'DEVICE', 'description': 'Investigational Medical Device collecting spectral raman data from tissue.', 'armGroupLabels': ['Long term collection of IMD data', 'Medium term collection of IMD data', 'Medium term collection of IMD data, increased # of sessions', 'Short term collection of IMD data']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jan Erik Henriksen, MD', 'role': 'CONTACT', 'email': 'Jan.Erik.Henriksen@rsyd.dk', 'phone': '+45 65411811'}], 'facility': 'Department of Endocrinology M', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Stefan Ovesen Banke, MSc', 'role': 'CONTACT', 'email': 'stefan@rspsystems.com', 'phone': '+45 71 99 79 77'}], 'overallOfficials': [{'name': 'Jan Erik Henriksen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital, Dpt. of Endocrinology M'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RSP Systems A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}