Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-28 @ 1:22 AM
Study NCT ID:
NCT07092761
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System performance', 'timeFrame': '14 days', 'description': 'The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements'}, {'measure': 'System-related Safety', 'timeFrame': '14 days', 'description': 'The CGM system will be characterized by adverse device effects experienced by the study participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1diabetes']}, 'descriptionModule': {'briefSummary': 'The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements.', 'detailedDescription': 'The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements. Up to 42 patients will be enrolled. Each patient will wear two sensors. Interstitial glucose readings from each sensor will be obtained immediatedly following each venous blood sample test. Each participant will make 4 visits to the clinical study site, including the screening visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagonsed with T1DM or T2DM\n* Venous blood sampling access can be established in the forearm\n* Capable of independently reading instructions and complying with the clinical trial requirements\n* Willing to sign the Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Severe hypoglycemia within the past 6 month\n* Heart failure or hemiplegic sequelae due to prior cerebrovascular disease\n* Severe skin conditions at the sensor wear site\n* Extensive systemic skin disorders\n* Coagulation disorders confirmed by the investigator\n* Anemia or abnormal hematocrit\n* Blood donation within the past 6 months\n* Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days\n* Current or recent (≤1 month) participation in other clinical trials\n* Planned MRI/CT scans during sensor wear\n* Allergy to medical adhesives or alcohol\n* Conditions impairing comprehension of informed consent or study procedures\n* Other exclusionary conditions per investigator's discretion"}, 'identificationModule': {'nctId': 'NCT07092761', 'briefTitle': 'Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System', 'organization': {'class': 'OTHER', 'fullName': 'Henan University of Science and Technology'}, 'officialTitle': 'Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System', 'orgStudyIdInfo': {'id': 'SS-KY-CGM-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adult patients with T1DM or T2DM', 'interventionNames': ['Device: GS3 CGM']}], 'interventions': [{'name': 'GS3 CGM', 'type': 'DEVICE', 'description': 'Wearing CGM for a consecutive 14 days', 'armGroupLabels': ['Adult patients with T1DM or T2DM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471003', 'city': 'Luoyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Liu', 'role': 'CONTACT', 'email': 'peng.liu87@outlook.com'}], 'facility': 'Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}], 'centralContacts': [{'name': 'Peng Liu', 'role': 'CONTACT', 'email': 'peng.liu87@outlook.com', 'phone': '0379-64811993'}], 'overallOfficials': [{'name': 'Hongwei Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Peng Liu', 'investigatorAffiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}}}}