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
- Conditions
- Insulin Pump，Continuous Glucose Monitoring Technology
- Interventions
- Registration Number
- NCT06127433
- Lead Sponsor
- Sun Yat-sen University
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description control group Dapagliflozin basal insulin and oral antidiabetic drugs control group Insulin Glargine basal insulin and oral antidiabetic drugs control group Metformin basal insulin and oral antidiabetic drugs intervention group Insulin aspart Intervention：insulin pump intensive therapy
- Primary Outcome Measures
Name Time Method Intergroup remission rate at 24 week 24 week Fasting blood glucose\<7mmol/L, and glycated hemoglobin\<6.5%
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
刘烈华
🇨🇳Guandong, China