Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-01-29 @ 1:27 PM
Study NCT ID:
NCT01511861
Status:
UNKNOWN
Last Update Posted:
2020-02-19
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Reliability of Non-invasive Blood 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 137}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2012-01-13', 'studyFirstSubmitQcDate': '2012-01-18', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.\n\nThe Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.\n\nThe primary objectives of the trial are to determine:\n\n1. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels compare to the standard glucose blood test\n2. Creating database of glucose levels readings utilizing the Glucometer GM-205.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with diabetes mellitus type 1 or type 2.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diabetes Mellitus type one or type two.\n2. Patients that are using Insulin.\n\nExclusion Criteria:\n\n1. Vascular diseases\n2. Pregnant and lactating women.\n3. Exclusive use of long term Insulin.'}, 'identificationModule': {'nctId': 'NCT01511861', 'briefTitle': 'Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlucoVista'}, 'officialTitle': 'Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device', 'orgStudyIdInfo': {'id': 'gluco02'}}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'country': 'Israel', 'facility': 'Edith Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlucoVista', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}