Diabetes Mellitus Complications, Diabetes Mellitus Type 2
Conditions
Brief summary
The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. The primary objective of this study is to verify the effectiveness of an AI model for predicting the risk of T2D complications based on phenotype, laboratory indicators and wearable device indicators, and to explore the effect and applicability of an intelligent lifestyle intervention model combining wearable devices and smartphones in preventing T2D complications.
Interventions
OTHERDevice: No specific devices
Routine doctor-patient interaction.
OTHERDevice: CGM,CGM management platform
Wearable monitoring + CGM management platform-assisted administration
OTHERDevice: "Professor Tang" WeChat Mini-program
Mini-program-assisted health management
OTHERDevice: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program
Wearable monitoring + mini-program integrated management
Sponsors
Second Xiangya Hospital of Central South University
First Hospital of China Medical University
The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital of Harbin Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Kunming Medical University
Tianjin Medical University
Shanghai 6th People's Hospital
Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
Sinocare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of Type 2 Diabetes; 2. Aged ≥ 18 years; 3. Able to accept the diabetes management model with AI-assisted management and wearable device monitoring; 4. Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.; 5. Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the informed consent form.
Exclusion criteria
1. Having severe mental illness or language barriers; 2. Suffering from malignant tumors; 3. Pregnant or lactating women; 4. Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.); 5. Severe hepatic and renal insufficiency (alanine transaminase and/or aspartate transaminase \> 3 times the upper limit of normal; estimated glomerular filtration rate \< 15 mL/min/1.73 m²); 6. A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy; 7. Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases; 8. Alcoholism or drug addiction; 9. Receiving insulin therapy; 10. Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline, 1 year | Between-group differences in HbA1c change (from Central Lab) |
Countries
China
Contacts
CONTACTHouDe Zhou, Prof.
Outcome results
None listed