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.
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.
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);
Parallel
Dapagliflozin (10mg Tab)
Drug10mg，qd
Continuous Glucose Monitoring (CGM)
Deviceused in Group A, Open-label continuous glucose monitoring (CGM) for glucose monitoring
Self-Monitoring of Blood Glucose (SMBG)
Other interventionFingertip self-monitoring of blood glucose (SMBG) using glucometer
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.
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.
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.
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Proportion of participants in each group with HbA1c \<7% after 12 weeks of treatment.
Key Secondary Outcome Measure: HbA1c Key Secondary Outcome Measure
Proportion of participants in each group with HbA1c \<6.5% after 12 weeks of treatment.
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.
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.
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.
Other exploratory endpoints：Change from Baseline in Fasting Serum Insulin
Change from baseline in fasting serum insulin level after 12 weeks of treatment.
Other exploratory endpoints：Change from Baseline in Serum C-Peptide
Change from baseline in serum C-peptide level after 12 weeks of treatment.
Other exploratory endpoints：Change from Baseline in Glucagon
Change from baseline in glucagon level after 12 weeks of treatment.
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