Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-29 @ 7:28 PM
Study NCT ID:
NCT05055804
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-16
First Post:
2021-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ELG Analysis of Glucose a Correlational to Blood Glucose Assay
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'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Clinical trials with a single arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2021-09-01', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event', 'timeFrame': 'Visit will last for up to 1-2 hours. This outcome will measure overnight fasting results.', 'description': 'Measuring precision and accuracy of ELG (glucose/A1C %) without blood samples, by performance evaluation to 3 different standard OTC fingerstick, A1C Now (or equivalent OTC brand) and NGSP-certified lab, using whole blood comparative tests with use of venous blood draw/fingersticks and NGSP-certified lab, and assess confidence limits to Bland-Altman plot, after overnight fasting for a minimum of 6 hours.'}, {'measure': 'Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Non-Fasting Event', 'timeFrame': 'This visit will be measured within a 4 week time frame, following the 1st visit. This visit will last for up to 1-2 hours. This outcome will measure non-fasting results.', 'description': 'Measuring precision and accuracy of ELG (glucose/A1C %) without blood samples, by performance evaluation to 3 different standard OTC fingerstick, A1C Now (or equivalent OTC brand) and NGSP-certified lab, using whole blood comparative tests with use of venous blood draw/fingersticks and NGSP-certified lab, and assess confidence limits to Bland-Altman plot, during non-fasting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ELG', 'Diabetes'], 'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study is an investigational study of the ELG medical device to monitor glucose blood level in diabetes mellitus Type 1 and 2 without blood samples in comparison to blood testing methods."Investigational" means the ELG medical device is subjected by the FDA (Food and Drug Administration) for premarket testing requirements. The purpose of this study is to collect data comparison values between ELG testing device to current blood testing methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed with type 1 or 2 diabetes\n* Be 25 - 65 years of age\n* Male or female\n* Various ethnicities are desired\n* Must be available for 2 visits within a 2-4 week period and willing to spend up to 1-2 hours/visit\n* Must have daytime availability for visits\n* Able to have 1 venous blood draw \\& up to 4 fingersticks for complete blood testing at each visit\n* Must be willing and able to fast (for at least 6 hours) prior to first visit\n\nExclusion Criteria:\n\n* Taking drugs of abuse (illegal and/or prescription)\n* Have been in another research study in the last 30 days\n* Have had a blood transfusion or severe blood loss in the last 14 days\n* Have Sickle Cell Anemia'}, 'identificationModule': {'nctId': 'NCT05055804', 'briefTitle': 'The ELG Analysis of Glucose a Correlational to Blood Glucose Assay', 'organization': {'class': 'OTHER', 'fullName': 'XP Technology, LLC'}, 'officialTitle': 'The ELG Analysis of Glucose a Correlational to Blood Glucose Assa', 'orgStudyIdInfo': {'id': 'Q151642/S001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ELG Device Comparison to Whole Blood Testing', 'description': 'Participant will place thumb in the ELG device for scan. Scan generally takes between 1-2 minutes. ELG then displays a readout of both a glucose and A1C reading on the screen of the ELG device.', 'interventionNames': ['Device: ELG']}], 'interventions': [{'name': 'ELG', 'type': 'DEVICE', 'otherNames': ['ELG, Easy Light Glycometer'], 'description': 'The effectiveness of ELG to standardized blood test methods (fingerstick) and comparison to AlcNOW + (or equivalence) and of laboratory test results.\n\nHuman subject requirements during ELG study will not challenge diabetics or non-diabetics glycemic event. For example, diabetes type 1, the subject will not have to adjust their insulin or glucose. For type 2 diabetes, the subject will not have to adjust their oral hypoglycemic agent or glucose, as well.', 'armGroupLabels': ['ELG Device Comparison to Whole Blood Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Rouse Family Medical Clinic', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}], 'overallOfficials': [{'name': 'Dr. Joe P Rouse, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr. Peter P Xaysanasy, DPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'XP Technology, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XP Technology, LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}