Insulin Pump，Continuous Glucose Monitoring Technology
Conditions
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.
Interventions
DRUGInsulin Glargine
Insulin Glargine
DRUGMetformin
Metformin
DRUGDapagliflozin
Dapagliflozin
DRUGInsulin aspart
Insulin aspart
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
basal insulin and oral antidiabetic drugs group insulin intensive therapy group
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intergroup remission rate at 24 week | 24 week | Fasting blood glucose\<7mmol/L, and glycated hemoglobin\<6.5% |
Countries
China
Contacts
Primary ContactLi Yanbing
Outcome results
None listed