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
Insulin Pump，Continuous Glucose Monitoring Technology
Intervention/treatment
Insulin Glargine
Metformin
Dapagliflozin
Insulin aspart
| Study Type : |
INTERVENTIONAL |
| Estimated Enrollment : |
210 participants |
| Masking : |
NONE |
| Primary Purpose : |
TREATMENT |
| Official Title : |
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 |
| Actual Study Start Date : |
2023-03-07 |
| Estimated Primary Completion Date : |
2024-05-01 |
| Estimated Study Completion Date : |
2024-12-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: |
18 Years
to 70 Years
|
| Sexes Eligible for Study: |
ALL |
| Accepts Healthy Volunteers: |
|
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 enrollment3: Age range from 18 to 70 years old, with a body mass index (BMI) of 20-35kg/m24: agrees to use contraception during the study process5: 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 diabetes2: The medication used is allergic or intolerable3: Acute complications of diabetes4: Severe microvascular complications5: Severe macrovascular complications6: Blood pressure consistently exceeds 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week7: 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 week8: Hemoglobin\<100g/L or requires regular blood transfusion treatment9: Accumulated time of using drugs that may affect blood sugar within 12 weeks for more than 1 week10: Systemic infection or severe accompanying diseases11: Patients with malignant tumors or chronic diarrhea12: Uncontrolled endocrine gland dysfunction13: Mental disorders14: Chronic heart failure, with a heart function grading of III or above15: 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\-