Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-16 @ 7:48 PM
Study NCT ID:
NCT02045758
Status:
UNKNOWN
Last Update Posted:
2014-09-03
First Post:
2014-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-02', 'studyFirstSubmitDate': '2014-01-22', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-Inferiority of Analyte Levels', 'timeFrame': 'Day 1', 'description': 'The study will compare the concentrations of various analytes in blood samples collected by both collection methods in a single 2 hour session.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Subject Group\n\n 1. Male and female volunteers 18 years of age or older.\n 2. Voluntary written consent to participate in this study. Diabetic Subject Group\n\n <!-- -->\n\n 1. Male and female volunteers 18 years of age or older.\n 2. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report.\n 3. Voluntary written consent to participate in this study.\n\nExclusion Criteria:\n\n1. Subjects who are pregnant or nursing mothers by self-report.\n2. Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.\n3. Subjects with a missing index or middle finger on either hand or a missing forearm\n4. Subjects who have known allergies to titanium.'}, 'identificationModule': {'nctId': 'NCT02045758', 'briefTitle': 'A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seventh Sense Biosystems'}, 'officialTitle': 'A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick', 'orgStudyIdInfo': {'id': '14-P002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP20-C', 'description': 'TAP20-C', 'interventionNames': ['Device: TAP20-C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fingerstick', 'description': 'Fingerstick', 'interventionNames': ['Device: Fingerstick']}], 'interventions': [{'name': 'Fingerstick', 'type': 'DEVICE', 'armGroupLabels': ['Fingerstick']}, {'name': 'TAP20-C', 'type': 'DEVICE', 'armGroupLabels': ['TAP20-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02141', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Seventh Sense Biosystems', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'centralContacts': [{'name': 'Howard Bernstein, MD, Phd', 'role': 'CONTACT', 'email': 'hbernstein@7sbio.com', 'phone': '617-547-7246'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seventh Sense Biosystems', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}