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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

NCT07595289 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Dapagliflozin (10mg Tab)

10mg，qd

DEVICE

Continuous Glucose Monitoring (CGM)

used in Group A, Open-label continuous glucose monitoring (CGM) for glucose monitoring

OTHER

Self-Monitoring of Blood Glucose (SMBG)

Fingertip self-monitoring of blood glucose (SMBG) using glucometer

Sponsors & Collaborators

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-12-31
Completion
2027-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595289 on ClinicalTrials.gov