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

Sponsor
Sun Yat-sen University
Study ID
NCT06127433
Phase
PHASE4
Status
Unknown

Conditions

  • Insulin Pump，Continuous Glucose Monitoring Technology

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Insulin Glargine — DRUG
    Insulin Glargine
  • Metformin — DRUG
    Metformin
  • Dapagliflozin — DRUG
    Dapagliflozin
  • Insulin aspart — DRUG
    Insulin aspart

Study Details

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.

Key Dates

Start date
Mar 7, 2023
Status verified
Nov 2023
Primary completion
May 1, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intervention group
    Intervention：insulin pump intensive therapy
  • Active Comparator: control group
    basal insulin and oral antidiabetic drugs

Primary Outcome Measure

Intergroup remission rate at 24 week [ Time Frame: 24 week ]

Central Contacts