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 | Not Yet Recruiting

• 1 other identifier: DP-DCT 1.0
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (3)

• Proportion of Participants Completing All DCT Procedures from Remote Informed Consent to Last Visit

  Proportion of enrolled participants who successfully complete all predefined decentralized clinical trial (DCT) procedures, including remote informed consent, electronic data capture, device connectivity, direct-to-patient drug delivery, scheduled follow-ups, and last study visit.

  through study completion, an average of 5 months

• Reliability Evaluation

  Implementation Rate of the DP-DCT Platform Function List: A digital intelligent clinical research platform that achieves full-process digitalization from participant recruitment to statistical reporting, along with technologies such as real-time generation of certified electronic copies of key data, must possess the following functions and meet the relevant assessment indicators.

  From study start to study completion (up to 24 months)

• Clinical Study Evaluation Indicators

  Difference between the two groups in the change of HbA1c from baseline after 12 weeks of treatment. Change from baseline/run-in period in Time in Range (TIR, 3.9-10 mmol/L) between the two groups.

  Baseline to Week 12

Secondary Outcomes (9)

• Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

  Week 12

• Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

  week 12

• Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

  week 12

• Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

  week 12

• Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

  week 12

Other Outcomes (6)

• Other exploratory endpoints：Proportion of patients achieving ≥5% or ≥10% body weight reduction from baseline

  week 12

• Other exploratory endpoints：Change from Baseline in Fasting Serum Insulin

  week 12

• Other exploratory endpoints：Change from Baseline in Serum C-Peptide

  week 12

Study Arms (2)

Group A：Dapagliflozin + CGM

EXPERIMENTAL

Initiate dapagliflozin therapy in combination with open-label CGM for glucose monitoring

Drug: Dapagliflozin (10mg Tab); Device: Continuous Glucose Monitoring (CGM)

Group B：Dapagliflozin + SMBG

EXPERIMENTAL

Initiate dapagliflozin therapy in combination with SMBG for fingertip blood glucose monitoring

Drug: Dapagliflozin (10mg Tab); Other: Self-Monitoring of Blood Glucose (SMBG)

Interventions

Dapagliflozin (10mg Tab) DRUG

10mg，qd

Group A：Dapagliflozin + CGM; Group B：Dapagliflozin + SMBG

Continuous Glucose Monitoring (CGM) DEVICE

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

Group A：Dapagliflozin + CGM

Self-Monitoring of Blood Glucose (SMBG) OTHER

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

Group B：Dapagliflozin + SMBG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily agree to participate in the study and sign the informed consent form; Age between 18 and 60 years (inclusive), both genders; Diagnosed with T2DM within 5 years and have not received any glucose-lowering medication in the past 3 months, with HbA1c ≥ 7% and ≤ 9%; Willing and able to maintain a stable lifestyle in terms of diet and exercise throughout the study period; Able to properly operate a smartphone, CGM, SMBG, smart scale, and smart wristband under the guidance and training of the investigator; During the CGM run-in period, obtain at least 70% data availability from the participants.

You may not qualify if:

• Diagnosed with or suspected of having type 1 diabetes mellitus, monogenic diabetes, or secondary diabetes; Experienced acute complications of diabetes (diabetic ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, etc.) within 3 months prior to screening;
• Severe comorbidities or medical history:
• Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
• Congestive heart failure (NYHA class III-IV);
• Severe hepatic or renal impairment (ALT/AST \> 3 × ULN, eGFR \< 30 mL/min);
• Malignant tumors, autoimmune diseases, severe infections, gastroparesis or other severe gastrointestinal diseases, hematological disorders;
• History of recurrent genitourinary tract infections; Alcohol abuse or alcoholic liver disease; Known or suspected allergy to SGLT-2 inhibitors (e.g., dapagliflozin) or medical adhesives; Received glucose-lowering medication within the past 3 months; Pregnant or breastfeeding women, or women planning to become pregnant during the study period; Presence of any medical, psychological, social, or geographical factors that, in the investigator's judgment, may compromise participant safety or interfere with the assessment of study outcomes.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Continuous Glucose Monitoring; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Self-Testing; Self Care; Therapeutics

Central Study Contacts

Yu xia Xiang

CONTACT

15974193674; 760809010@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Pharmacist

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share