DP-DCT 1.0：A Comparative Clinical Study on the Effect of Dapagliflozin Combined With CGM Versus SMBG on Glycemic Control in Patients With Type 2 Diabetes Mellitus Based on the DP-DCT Platform

Sponsor
The Third Xiangya Hospital of Central South University
Study ID
NCT07595289
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (10mg Tab) — DRUG
    10mg，qd
  • Continuous Glucose Monitoring (CGM) — DEVICE
    used in Group A, Open-label continuous glucose monitoring (CGM) for glucose monitoring
  • Self-Monitoring of Blood Glucose (SMBG) — OTHER
    Fingertip self-monitoring of blood glucose (SMBG) using glucometer

Study Details

The goal of this clinical trial is to: 1\) evaluate the feasibility of conducting decentralized clinical trials (DCT) in collaboration with community resources; 2) test the reliability of a self-developed Digital Platform for Decentralized Clinical Trials (DP-DCT); and 3) compare the effect of two different glucose monitoring methods on glycemic control in patients with type 2 diabetes mellitus (T2DM). The study population consists of adults with T2DM who do not have acute diabetic complications. The main questions it aims to answer are: Is it feasible to conduct a DCT in collaboration with community settings across key steps such as participant recruitment, informed consent, drug delivery, and remote monitoring? Can the DP-DCT platform reliably achieve full electronic integration from participant recruitment to statistical reporting, and automatically generate verified electronic copies of key source data in real time? In patients taking dapagliflozin, does continuous glucose monitoring (CGM) lead to a higher rate of glycemic control target achievement compared to traditional self-monitoring of blood glucose (SMBG)? Researchers will compare the CGM group (dapagliflozin + CGM) and the SMBG group (dapagliflozin + SMBG) to see if there is a difference in the rate of achieving glycemic control targets after 12 weeks of treatment. Participants will: Wear a blinded CGM device for 7days before starting treatment (run-in period) to assess eligibility for randomization. Take dapagliflozin (10 mg once daily) and maintain healthy lifestyle habits. Monitor their blood glucose using either a CGM device or a traditional glucose meter according to their group assignment. Wear a smart bracelet and use a smart weight scale, with all data automatically uploaded via the DP-DCT platform. Wear a blinded CGM device again for 7 days after the 12-week treatment period (follow-up period). Complete most study procedures (including informed consent, drug receipt, and follow-up communication) through an online platform without frequent hospital visits, with some tasks supported by community hospitals.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group A：Dapagliflozin + CGM
    Initiate dapagliflozin therapy in combination with open-label CGM for glucose monitoring
  • Experimental: Group B：Dapagliflozin + SMBG
    Initiate dapagliflozin therapy in combination with SMBG for fingertip blood glucose monitoring

Primary Outcome Measure

Proportion of Participants Completing All DCT Procedures from Remote Informed Consent to Last Visit [ Time Frame: through study completion, an average of 5 months ]

Central Contacts

Related Studies