Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT06127433
Status:
UNKNOWN
Last Update Posted:
2023-11-13
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'basal insulin and oral antidiabetic drugs group insulin intensive therapy group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intergroup remission rate at 24 week', 'timeFrame': '24 week', 'description': 'Fasting blood glucose\\<7mmol/L, and glycated hemoglobin\\<6.5%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Pump，Continuous Glucose Monitoring Technology']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the effectiveness and safety of the in-hospital-out-of-hospital synergistic short-term insulin intensive therapy model based on patch insulin pump and continuous glucose monitoring technology through a randomized controlled study, and evaluate the possibility of blood glucose parameters derived from continuous glucose technology in predicting long-term blood glucose remission, so as to provide important reference data for the precision, intelligence, and integrated improvement of short-term insulin intensive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:1: Have never received any hypoglycemic treatment (including oral hypoglycemic drugs, traditional Chinese medicine hypoglycemic drugs, insulin) Type 2 diabetes patients, or type 2 diabetes patients with diagnosis time less than 1 year, use hypoglycemic drugs No more than 1 type, with a usage time of no more than 1 week, and discontinuation of medication for more than 1 week when selected\n\n2: A1c of glycosylated hemoglobin ≥ 8.0%, and abdominal blood glucose\\>7.0mmol/L during enrollment\n\n3: Age range from 18 to 70 years old, with a body mass index (BMI) of 20-35kg/m2\n\n4: agrees to use contraception during the study process\n\n5: Able and willing to use a dynamic blood glucose system and monitor blood glucose according to project requirements, and accept out of hospital lifestyle management and insulin hypoglycemic management.\n\n\\-\n\nExclusion Criteria:1: Not type 2 diabetes\n\n2: The medication used is allergic or intolerable\n\n3: Acute complications of diabetes\n\n4: Severe microvascular complications\n\n5: Severe macrovascular complications\n\n6: Blood pressure consistently exceeds 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week\n\n7: The clearance rate of blood creatinine is less than 45ml/min/1.73m2, the ALT is ≥ 3 times the normal upper limit, and the total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week\n\n8: Hemoglobin\\<100g/L or requires regular blood transfusion treatment\n\n9: Accumulated time of using drugs that may affect blood sugar within 12 weeks for more than 1 week\n\n10: Systemic infection or severe accompanying diseases\n\n11: Patients with malignant tumors or chronic diarrhea\n\n12: Uncontrolled endocrine gland dysfunction\n\n13: Mental disorders\n\n14: Chronic heart failure, with a heart function grading of III or above\n\n15: Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period, or have surgery plans that require general anesthesia in the near future (within 6 months)\n\n16: The subject is uncooperative, unable to follow up, or the researcher determines that it may be difficult to complete the study.\n\n17: Other situations that the researcher determines are not suitable for inclusion\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06127433', 'briefTitle': 'The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IIT-2022-816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Intervention：insulin pump intensive therapy', 'interventionNames': ['Drug: Insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'basal insulin and oral antidiabetic drugs', 'interventionNames': ['Drug: Insulin Glargine', 'Drug: Metformin', 'Drug: Dapagliflozin']}], 'interventions': [{'name': 'Insulin Glargine', 'type': 'DRUG', 'description': 'Insulin Glargine', 'armGroupLabels': ['control group']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin', 'armGroupLabels': ['control group']}, {'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Dapagliflozin', 'armGroupLabels': ['control group']}, {'name': 'Insulin aspart', 'type': 'DRUG', 'description': 'Insulin aspart', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': '烈华 刘', 'role': 'CONTACT'}], 'facility': '刘烈华', 'geoPoint': {'lat': 32.17424, 'lon': 120.10228}}], 'centralContacts': [{'name': 'Li Yanbing', 'role': 'CONTACT', 'email': 'liyb@mail.sysu.edu.cn', 'phone': '13925111691'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Yanbing Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}