Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 2:43 AM
Study NCT ID:
NCT00889668
Status:
UNKNOWN
Last Update Posted:
2012-05-01
First Post:
2009-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-29', 'studyFirstSubmitDate': '2009-04-28', 'studyFirstSubmitQcDate': '2009-04-28', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clarke Error Grid', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'User Satisfaction', 'timeFrame': 'one year', 'description': 'Based on user questionnaire, user satisfection will be analyzed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glucose monitoring', 'GlucoTrack', 'Self glucose monitoring'], 'conditions': ['Type 1 Diabetes Mellitus', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics.\n\nThe purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels.\n\nThe rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes", 'detailedDescription': 'See Brief summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1or 2 Diabetes\n* Anatomically suitable earlobe\n\nExclusion Criteria:\n\n* Subjects requiring dialysis\n* Any conditions that may hamper good contact between the PEC and the earlobe\n* Pregnancy\n* Nursing mothers'}, 'identificationModule': {'nctId': 'NCT00889668', 'acronym': 'CR-01-001', 'briefTitle': 'Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrity Applications Ltd.'}, 'officialTitle': 'Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.', 'orgStudyIdInfo': {'id': 'CR-01-001 CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.', 'interventionNames': ['Device: GlucoTrack']}], 'interventions': [{'name': 'GlucoTrack', 'type': 'DEVICE', 'description': 'comparison of different glucose monitoring devices', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Adi Gluzberg', 'role': 'CONTACT', 'email': 'adi_g@medicsense.com', 'phone': '+972-52-6401020'}, {'name': 'Ilana Harman-Boehm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Sagit Saadon, MA', 'role': 'CONTACT', 'phone': '+972 (8) 675-7878'}], 'overallOfficials': [{'name': 'Ilana Harman-Boehm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center, Dept of Internal Medicine C and Director of the Diabetes Unit at Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrity Applications Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}