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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Intervention:insulin pump intensive therapy |
|
| control group | Active Comparator | basal insulin and oral antidiabetic drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Insulin Glargine |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Intergroup remission rate at 24 week | Fasting blood glucose<7mmol/L, and glycated hemoglobin<6.5% | 24 week |
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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.
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Yanbing | Contact | 13925111691 | liyb@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 刘烈华 | Recruiting | Guandong | China |
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basal insulin and oral antidiabetic drugs group insulin intensive therapy group
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| Drug |
Metformin |
|
| Dapagliflozin | Drug | Dapagliflozin |
|
| Insulin aspart | Drug | Insulin aspart |
|
| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| C529054 | dapagliflozin |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D061266 | Insulin, Short-Acting |
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