Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-27 @ 5:12 AM
Study NCT ID:
NCT03235492
Status:
WITHDRAWN
Last Update Posted:
2023-12-20
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salivary Glycated Albumin
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study team did not receive the necessary study equipment from our international partners.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-07-28', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary glycated albumin vs. blood glycated albumin', 'timeFrame': '30 min', 'description': 'Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood.'}, {'measure': 'Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)', 'timeFrame': '30 min', 'description': 'To investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure HbA1c.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'salivary glycated albumin', 'HbA1c'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '(1) to determine whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin (HbA1c).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 123 individuals with type 1 or type 2 diabetes\n* 53 non diabetic controls\n* Age: 18 to 80\n* Body mass index \\>18.5kg / m2\n\nExclusion Criteria:\n\n* Acute illness (within 7 days) - respiratory infection, fever above 38 °C, sinusitis infection, severe allergies.\n* Individuals with known sickle cell, pregnancy, hemoglobinopathies, renal failure\n* Subjects unable to give voluntary informed consent'}, 'identificationModule': {'nctId': 'NCT03235492', 'briefTitle': 'Salivary Glycated Albumin', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Clinical Study of Salivary Glycated Albumin', 'orgStudyIdInfo': {'id': 'HP-00076395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SmartAlbu', 'description': 'If a participant agrees, after obtaining informed consent, the investigator will measure and record temperature, blood pressure, heart rate, height and weight. The participant will be given detailed instruction on how to hold the container and will be asked to spit (or deposit) their saliva up to the indicated line. The procedure will be performed twice to study the reproducibility of the test. The participant will then be asked to have a standard blood draw of 2-3 mls of blood into a vacutainer tube for analysis of HbA1c at the central lab and 1-2 mls of blood for glycated albumin for assay analysis, and a finger stick for point of care HbA1c measurement.', 'interventionNames': ['Device: SmartAlbu']}], 'interventions': [{'name': 'SmartAlbu', 'type': 'DEVICE', 'description': 'Plan:\n\n1. Consent an individual\n2. Measure and record temperature, blood pressure, heart rate, height and weight\n3. Obtain two samples of saliva for the SmartAlbu portable salivary sensor\n4. Take a venous blood sample for HbA1c and\n5. Glycated albumin\n6. Obtain blood sample from a finger stick for point of care HbA1c device', 'armGroupLabels': ['SmartAlbu']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Stephen N Davis, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of Medicine', 'investigatorFullName': 'Stephen N. Davis, MBBS', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}