Type 2 Diabetes Mellitus (T2DM)DP DCTNCT07595289
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
A study testing Dapagliflozin (10mg Tab), Continuous Glucose Monitoring (CGM) and Self-Monitoring of Blood Glucose (SMBG) in people with Type 2 Diabetes Mellitus (T2DM), run by The Third Xiangya Hospital of Central South University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Dapagliflozin (10mg Tab), Continuous Glucose Monitoring (CGM) and Self-Monitoring of Blood Glucose (SMBG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
The goal of this clinical trial is to:
- 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.
Read more
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)
- Being tested
- Dapagliflozin (10mg Tab), Continuous Glucose Monitoring (CGM), Self-Monitoring of Blood Glucose (SMBG)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Group A：Dapagliflozin + CGM | Experimental | Initiate dapagliflozin therapy in combination with open-label CGM for glucose monitoring Receives: 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 Receives: Drug: Dapagliflozin (10mg Tab); Other: Self-Monitoring of Blood Glucose (SMBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Secondary outcomes (9)
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Proportion of participants in each group with HbA1c <7% after 12 weeks of treatment.
Measured: Week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Proportion of participants in each group with HbA1c <6.5% after 12 weeks of treatment.
Measured: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Proportion of participants in each group with a reduction in HbA1c of ≥0.5% from baseline after 12 weeks of treatment.
Measured: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Proportion of participants in each group with a reduction in HbA1c of ≥1% from baseline after 12 weeks of treatment.
Measured: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
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.
Measured: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Change from baseline in fasting serum glucose (FPG) after 12 weeks of treatment.
Measured: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics
Change from baseline/run-in period to the CGM follow-up period in Time Above Range (TAR, ≥10 mmol/L) between the two groups.
Measured: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics
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.
Measured: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics
Comparison of the coefficient of variation (CV) of glucose
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595289
- Sponsor's protocol ID
- DP-DCT 1.0
- Acronym
- DP DCT
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07595289
- Acronym / sponsor ID
- DP DCT / DP-DCT 1.0
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A：Dapagliflozin + CGM | Experimental | Drug: Dapagliflozin (10mg Tab), Device: Continuous Glucose Monitoring (CGM)Initiate dapagliflozin therapy in combination with open-label CGM for glucose monitoring |
| Group B：Dapagliflozin + SMBG | Experimental | Drug: Dapagliflozin (10mg Tab), Other: Self-Monitoring of Blood Glucose (SMBG)Initiate dapagliflozin therapy in combination with SMBG for fingertip blood glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin (10mg Tab)10mg，qd | Drug | Group A：Dapagliflozin + CGM, Group B：Dapagliflozin + SMBG |
| Continuous Glucose Monitoring (CGM)used in Group A, Open-label continuous glucose monitoring (CGM) for glucose monitoring | Device | Group A：Dapagliflozin + CGM |
| Self-Monitoring of Blood Glucose (SMBG)Fingertip self-monitoring of blood glucose (SMBG) using glucometer | Other | Group B：Dapagliflozin + SMBG |
Primary outcome
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.
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.
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.
9 secondary outcomes
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Time frame: Week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Time frame: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Time frame: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Time frame: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Time frame: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Time frame: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics
Time frame: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics
Time frame: week 12
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics
Time frame: week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin (10mg Tab), Continuous Glucose Monitoring (CGM) and Self-Monitoring of Blood Glucose (SMBG) in people with Type 2 Diabetes Mellitus (T2DM), run by The Third Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu xia Xiang (15974193674, 760809010@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.