Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07595289

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: through study completion, an average of 5 months

    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.

  2. Reliability Evaluation

    Time frame: From study start to study completion (up to 24 months)

    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.

  3. Clinical Study Evaluation Indicators

    Time frame: Baseline to Week 12

    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.

Secondary outcomes

  1. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

    Time frame: Week 12

    Proportion of participants in each group with HbA1c <7% after 12 weeks of treatment.

  2. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

    Time frame: week 12

    Proportion of participants in each group with HbA1c <6.5% after 12 weeks of treatment.

  3. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

    Time frame: week 12

    Proportion of participants in each group with a reduction in HbA1c of ≥0.5% from baseline after 12 weeks of treatment.

  4. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

    Time frame: week 12

    Proportion of participants in each group with a reduction in HbA1c of ≥1% from baseline after 12 weeks of treatment.

  5. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

    Time frame: week 12

    Proportion of participants in each group with either a reduction in HbA1c of ≥1% from baseline or an HbA1c <7.0% after 12 weeks of treatment.

  6. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure

    Time frame: week 12

    Change from baseline in fasting serum glucose (FPG) after 12 weeks of treatment.

  7. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics

    Time frame: week 12

    Change from baseline/run-in period to the CGM follow-up period in Time Above Range (TAR, ≥10 mmol/L) between the two groups.

  8. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics

    Time frame: week 12

    Change from baseline/run-in period to the CGM follow-up period in Time Below Range (TBR, <3.9 mmol/L) between the two groups.

  9. Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics

    Time frame: week 12

    Comparison of the coefficient of variation (CV) of glucose

Other outcomes

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

    Time frame: week 12

    Proportion of patients achieving ≥5% reduction from baseline in body weight at 12 weeks, and proportion achieving ≥10% reduction.

  2. Other exploratory endpoints：Change from Baseline in Fasting Serum Insulin

    Time frame: week 12

    Change from baseline in fasting serum insulin level after 12 weeks of treatment.

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

    Time frame: week 12

    Change from baseline in serum C-peptide level after 12 weeks of treatment.

  4. Other exploratory endpoints：Change from Baseline in Glucagon

    Time frame: week 12

    Change from baseline in glucagon level after 12 weeks of treatment.

  5. Other exploratory endpoints：Change from Baseline in HOMA-β

    Time frame: week 12

    Change from baseline in homeostatic model assessment of β-cell function (HOMA-β) after 12 weeks of treatment.

  6. Other exploratory endpoints：Change from Baseline in HOMA-IR

    Time frame: week 12

    Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR) after 12 weeks of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu xia Xiang

CONTACT

[email protected]

15974193674

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Acronym: DP DCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.