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 Overview
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Brief Summary
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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.

Official Title
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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
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Insulin Pump，Continuous Glucose Monitoring Technology

Intervention / Treatment
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* Drug: Insulin Glargine
* Drug: Metformin
* Drug: Dapagliflozin
* Drug: Insulin aspart


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: basal insulin and oral antidiabetic drugs group insulin intensive therapy group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Intervention：insulin pump intensive therapy | Drug: Insulin aspart<br>* Insulin aspart<br>|
| Active Comparator: control group<br>basal insulin and oral antidiabetic drugs | Drug: Insulin Glargine<br>* Insulin Glargine<br>Drug: Metformin<br>* Metformin<br>Drug: Dapagliflozin<br>* Dapagliflozin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intergroup remission rate at 24 week | Fasting blood glucose<7mmol/L, and glycated hemoglobin<6.5% | 24 week |