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

NCT ID: NCT06127433

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-07
• Study Completion Date: 2024-12-30

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.

Conditions

Insulin Pump，Continuous Glucose Monitoring Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention group

Intervention：insulin pump intensive therapy

Group Type: EXPERIMENTAL

Insulin aspart

Intervention Type: DRUG

Insulin aspart

control group

basal insulin and oral antidiabetic drugs

Group Type: ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type: DRUG

Insulin Glargine

Metformin

Intervention Type: DRUG

Metformin

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin

Interventions

Insulin Glargine

Insulin Glargine

Intervention Type: DRUG

Metformin

Metformin

Intervention Type: DRUG

Dapagliflozin

Dapagliflozin

Intervention Type: DRUG

Insulin aspart

Insulin aspart

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanbing Li

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

刘烈华

Guandong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Yanbing

Role: CONTACT

liyb@mail.sysu.edu.cn

13925111691

Facility Contacts

烈华 刘

Role: primary

Other Identifiers

IIT-2022-816

Identifier Type: -

Identifier Source: org_study_id