Clinical trial NCT06127433: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Insulin Pump，Continuous Glucose Monitoring Technology
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: basal insulin and oral antidiabetic drugs group insulin intensive therapy group
Primary purpose: TREATMENT

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.


Eligibility 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.

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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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Primary outcomes:
measure: Intergroup remission rate at 24 week
timeFrame: 24 week
Secondary outcomes:
Other outcomes:
Locations:
city: Guandong
country: China
facility: 刘烈华
Study officials:
References: