Type 2 diabetes
Conditions
Interventions
Group A:Initiate dapagliflozin therapy in combination with open-label continuous glucose monitoring for glucose monitoring
Group B:Initiate dapagliflozin therapy in combination with self-monitoring of blood glucose for fingertip blood glucose monitoring
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in the study and sign the informed consent form; 2. Age between 18 and 60 years (inclusive), both genders; 3. Diagnosed with T2DM within 5 years and have not received any glucose-lowering medication in the past 3 months, with HbA1c >= 7% and <= 9%; 4. Willing and able to maintain a stable lifestyle in terms of diet and exercise throughout the study period; 5. Able to properly operate a smartphone, CGM, SMBG, smart scale, and smart wristband under the guidance and training of the investigator; 6. During the CGM run-in period, obtain at least 70% data availability from the participants.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with or suspected of having type 1 diabetes mellitus, monogenic diabetes, or secondary diabetes; 2. Experienced acute complications of diabetes (diabetic ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, etc.) within 3 months prior to screening; 3. Severe comorbidities or medical history: (1) Poorly controlled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure >= 100 mmHg); (2) Congestive heart failure (NYHA class III–IV); (3) Severe hepatic or renal impairment (ALT/AST > 3 × ULN, eGFR < 30 mL/min); (4) Malignant tumors, autoimmune diseases, severe infections, gastroparesis or other severe gastrointestinal diseases, hematological disorders; (5) History of recurrent genitourinary tract infections; 4. Alcohol abuse or alcoholic liver disease; 5. Known or suspected allergy to SGLT-2 inhibitors (e.g., dapagliflozin) or medical adhesives; 6. Received glucose-lowering medication within the past 3 months; 7. Pregnant or breastfeeding women, or women planning to become pregnant during the study period; 8. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group difference in HbA1c change from baseline at 12 weeks.;Change from baseline/run-in in TIR (3.9–10 mmol/L) in both groups.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion with HbA1c =10 mmol/L) in both groups.; | — |
Countries
China
Contacts
Public ContactGuoping Yang, Ping Jin
The Third Xiangya Hospital of Central South University
Outcome results
None listed