Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT04096794
Status:
RECRUITING
Last Update Posted:
2023-04-21
First Post:
2019-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2019-09-02', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in serum hemoglobin A1c level', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'A1c reflects the average blood glucose level in the past 3 months.'}], 'secondaryOutcomes': [{'measure': 'changes in Time in range (TIR)', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'TIR measures the time where the blood glucose remains within the proposed target range.'}, {'measure': 'C-peptide', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study'}, {'measure': 'Change in titer of autoantibodies', 'timeFrame': 'Baseline and every up to 12 weeks afterwards'}, {'measure': 'Fasting blood glucose', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'the blood sugar level after fasting for eight hours'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'Systolic blood pressure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'Diastolic blood pressure'}, {'measure': 'Change in lipid profiles', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol'}, {'measure': 'Height in meters', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'Height in meters will be measured'}, {'measure': 'Weight in kilograms', 'timeFrame': 'Baseline and every every up to 12 weeks afterwards', 'description': 'Weight in kilograms will be measured'}, {'measure': 'Stool samples', 'timeFrame': 'Baseline and every up to 12 weeks afterwards'}, {'measure': 'Adverse effects', 'timeFrame': 'Baseline and every up to 12 weeks afterwards', 'description': 'Adverse effects are recorded at each time-point of the follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The China Alliance for Type 1 Diabetes (CAT1D) is committed to exploring and implementing the model of graded diagnosis and treatment of type 1 diabetes and comprehensive management of outpatient service, carrying out a series of educational activities for patients, and cooperating in the development of multi-center prospective clinical research on type 1 diabetes.', 'detailedDescription': '1. Through the CAT1D, expand the cohort construction of type 1 diabetes patients and first-level relatives in China, establish the electronic information database of type 1 diabetes, and lay a foundation for obtaining the research data of type 1 diabetes in China.\n2. observe and study the occurrence and development rules of acute and chronic complications of type 1 diabetes in China, analyze the influencing factors, and provide intervention means for reducing acute complications and preventing chronic complications.\n3. Through the established management platform and structured education system, verify and promote the comprehensive management mode based on structured education, and build a standard treatment plan and process based on evidence-based science and suitable for Chinese people and medical background.\n4. By using mobile health (mHealth) and Artificial Intelligence (AI) technologies, a new mode of intelligent structured education is established, which provides a new way to explore the individualized education management mode and improve the outcome of chronic diseases through modern technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'type 1 diabetes patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report\n* Written informed consent from the patient or family representative;\n* Individuals who own smartphone and are capable of using wechat or apps\n\nExclusion Criteria:\n\n* Non-t1dm patients with autoimmune polyendocrine adenopathy syndrome (APS) are the first disease\n* With mental disorders\n* Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial'}, 'identificationModule': {'nctId': 'NCT04096794', 'briefTitle': 'Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research', 'organization': {'class': 'OTHER', 'fullName': 'Second Xiangya Hospital of Central South University'}, 'officialTitle': 'Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research', 'orgStudyIdInfo': {'id': 'CAT1D2019CS0011'}}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiguang Zhou, MD/PhD', 'role': 'CONTACT', 'email': 'zhouzg@hotmail.com', 'phone': '86-731-85292154'}], 'facility': 'Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor,Institute of Metabolism and Endocrinology, The Second Xiangya Hospital and the Diabetes Center, Key Laboratory of Diabetes Immunology, Ministry of Education, Central South University, National Clinical Research Center for Metabolic Diseases.', 'investigatorFullName': 'Zhiguang Zhou', 'investigatorAffiliation': 'Second Xiangya Hospital of Central South University'}}}}