Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 2:58 AM
Study NCT ID:
NCT05995756
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2023-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall mean absolute relative difference (MARD)', 'timeFrame': '8 or 15 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 or Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation \\[SD\\] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose \\& Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (Aged ≥18) TD1 and TD2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥18 years, male or female;\n2. Clinically diagnosed with diabetes;\n3. Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;\n4. Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Disagree to wear the investigational device continuously according to the requirements of the trial;\n2. Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;\n3. Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;\n4. With diffuse subcutaneous nodules at the wearing site of the investigational device;\n5. Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;\n6. With mental disorders, lack of self-control and inability to express clearly;\n7. Have participated in any other clinical trial within the past 1 month;\n8. Where the investigator thinks not suitable for being enrolled.'}, 'identificationModule': {'nctId': 'NCT05995756', 'briefTitle': 'Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinocare'}, 'officialTitle': 'Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose', 'orgStudyIdInfo': {'id': 'NPI031-CIP-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'In pateint'}, {'label': 'Out pateint'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Pinggu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinocare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}