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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: intervention group Intervention：insulin pump intensive therapy |
Drug: Insulin aspart
Insulin aspart
|
| Active Comparator: control group basal insulin and oral antidiabetic drugs |
Drug: Insulin Glargine
Insulin Glargine
Drug: Metformin
Metformin
Drug: Dapagliflozin
Dapagliflozin
|
Outcome Measures
Primary Outcome Measures
- Intergroup remission rate at 24 week [24 week]
Fasting blood glucose<7mmol/L, and glycated hemoglobin<6.5%
Eligibility Criteria
Criteria
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
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 Criteria: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
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 刘烈华 | Guandong | China |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIT-2022-816