Diabetes
Conditions
Interventions
Intervention group:Participants in the intervention group will receive artificial intelligence-assisted lifestyle guidance during the intervention period. Participants will wear CGM and wearable devic
Control group:Participants in the control group will receive standard care and routine guideline-based lifestyle guidance during the intervention period. Participants will wear CGM and wearable device
Sponsors
Shanghai Health and Medical Center
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40–75 years; 2. Diagnosed with type 2 diabetes mellitus; 3. Stable use of the current glucose-lowering medication regimen for at least 3 months; 4. HbA1c between 6.5% and 10.0%; 5. Owning a smartphone and able to operate mobile applications; 6. Willing and able to wear study devices, including a continuous glucose monitoring device and an activity wristband; 7. Willing to use the study-designated terminals, comply with study procedures, understand the study, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Use of prandial insulin or premixed insulin; 2. Severe chronic diabetic complications; 3. Acute diabetic complications within the past 3 months; 4. Early-onset diabetes diagnosed before 40 years of age; 5. Severe chronic diseases, including severe cardiovascular or cerebrovascular disease such as myocardial infarction or stroke within the past 6 months, uncontrolled hypertension (>180/110 mmHg), active liver disease, or malignancy; 6. Severe psychiatric disease or cognitive impairment that may affect participation; 7. Pregnancy, lactation, or planned pregnancy; 8. Allergy to CGM sensor materials; 9. Planned major surgery or long-distance travel during the study period; 10. Any condition that, in the investigator’s judgment, may affect participant safety, adherence, or outcome evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in CGM-derived metrics;Change in glucose metabolism measures;Change in lipid profile;Change in laboratory measures;Change in anthropometric and body composition measures;Change in patient-reported outcomes and psychological questionnaire scores;Change in cognitive function measures;Change in hepatic steatosis-related measures;Change in lifestyle behaviour measures;Multi-terminal interaction experience and usability evaluation; | — |
Countries
China
Contacts
Public ContactTingli Chen
Shanghai Health and Medical Center
Outcome results
None listed