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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A:Dapagliflozin + CGM | Experimental | Initiate dapagliflozin therapy in combination with open-label CGM for glucose monitoring |
|
| Group B:Dapagliflozin + SMBG | Experimental | Initiate dapagliflozin therapy in combination with SMBG for fingertip blood glucose monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin (10mg Tab) | Drug | 10mg,qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure | Proportion of participants in each group with HbA1c <7% after 12 weeks of treatment. | Week 12 |
| Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure |
| Measure | Description | Time Frame |
|---|---|---|
| Other exploratory endpoints:Proportion of patients achieving ≥5% or ≥10% body weight reduction from baseline | Proportion of patients achieving ≥5% reduction from baseline in body weight at 12 weeks, and proportion achieving ≥10% reduction. | week 12 |
| Other exploratory endpoints:Change from Baseline in Fasting Serum Insulin |
Inclusion Criteria:
Exclusion Criteria:
Severe comorbidities or medical history:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu xia Xiang | Contact | 15974193674 | 760809010@qq.com |
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| 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 |
|
Proportion of participants in each group with HbA1c <6.5% after 12 weeks of treatment.
| 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. | 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. | 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. | week 12 |
| Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure | Change from baseline in fasting serum glucose (FPG) after 12 weeks of treatment. | 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. | 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. | week 12 |
| Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure: CGM Metrics | Comparison of the coefficient of variation (CV) of glucose | week 12 |
Change from baseline in fasting serum insulin level after 12 weeks of treatment. |
| week 12 |
| Other exploratory endpoints:Change from Baseline in Serum C-Peptide | Change from baseline in serum C-peptide level after 12 weeks of treatment. | week 12 |
| Other exploratory endpoints:Change from Baseline in Glucagon | Change from baseline in glucagon level after 12 weeks of treatment. | week 12 |
| Other exploratory endpoints:Change from Baseline in HOMA-β | Change from baseline in homeostatic model assessment of β-cell function (HOMA-β) after 12 weeks of treatment. | week 12 |
| Other exploratory endpoints:Change from Baseline in HOMA-IR | Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR) after 12 weeks of treatment. | week 12 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D000095583 | Continuous Glucose Monitoring |
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
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