Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT01346033
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2011-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of SCOUT DS in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of SCOUT DS algorithm for detecting known type 2 diabetes', 'timeFrame': '1 day', 'description': 'Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Adults 18 years and older', 'Taking Control of Your Diabetes Health Fair'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.', 'detailedDescription': 'Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age greater than or equal to 18 years\n2. Self-reported diagnosis of type 2 diabetes\n\nExclusion Criteria:\n\n* Not diagnosed with type 2 diabetes\n\n * Diagnosed with type 1 diabetes\n * Known to be pregnant (Self Reported)\n * Receiving dialysis or having known renal compromise\n * Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.\n * Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)'}, 'identificationModule': {'nctId': 'NCT01346033', 'acronym': 'TCOYD', 'briefTitle': 'Evaluation of SCOUT DS in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'VeraLight, Inc.'}, 'officialTitle': 'An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'VL-2714'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Those with Type 2 diabetes', 'description': 'All subjects have been diagnosed with type 2 diabetes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Convention Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Martin L Kabongo, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Accelovance San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VeraLight, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}