Status:
UNKNOWN
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
Lead Sponsor:
Sun Yat-sen University
Conditions:
Insulin Pump，Continuous Glucose Monitoring Technology
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 mon...
Eligibility Criteria
Inclusion
- 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
- 2: A1c of glycosylated hemoglobin ≥ 8.0%, and abdominal blood glucose\>7.0mmol/L during enrollment
- 3: Age range from 18 to 70 years old, with a body mass index (BMI) of 20-35kg/m2
- 4: agrees to use contraception during the study process
- 5: 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.
- \-
Exclusion
- 1: Not type 2 diabetes
- 2: The medication used is allergic or intolerable
- 3: Acute complications of diabetes
- 4: Severe microvascular complications
- 5: Severe macrovascular complications
- 6: Blood pressure consistently exceeds 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week
- 7: 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
- 8: Hemoglobin\<100g/L or requires regular blood transfusion treatment
- 9: Accumulated time of using drugs that may affect blood sugar within 12 weeks for more than 1 week
- 10: Systemic infection or severe accompanying diseases
- 11: Patients with malignant tumors or chronic diarrhea
- 12: Uncontrolled endocrine gland dysfunction
- 13: Mental disorders
- 14: Chronic heart failure, with a heart function grading of III or above
- 15: 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)
- 16: The subject is uncooperative, unable to follow up, or the researcher determines that it may be difficult to complete the study.
- 17: Other situations that the researcher determines are not suitable for inclusion
- \-
Key Trial Info
Start Date :
March 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06127433
Start Date
March 7 2023
End Date
December 30 2024
Last Update
November 13 2023
Active Locations (1)
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1
刘烈华
Guandong, China