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Recruiting Not applicable

Mobile Health and Wearable Devices for Diabetes Complication Management

NCT07129148 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2026-06-01

Condition(s) studied

Diabetes Mellitus Type 2Diabetes Mellitus Complications

Investigational drug(s) / intervention(s)

Device: No specific devicesDevice: CGM,CGM management platformDevice: "Professor Tang" WeChat Mini-programDevice: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program

Device: No specific devices: Routine doctor-patient interaction.

Device: CGM,CGM management platform: Wearable monitoring + CGM management platform-assisted administration

Device: "Professor Tang" WeChat Mini-program: Mini-program-assisted health management

Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program: Wearable monitoring + mini-program integrated management

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.).

Primary outcome measure(s)

  • HbA1c — Baseline, 1 year
    Between-group differences in HbA1c change (from Central Lab)

Trial sites (1)

FacilityCityRegionStatus
Second Xiangya Hospital of Central South University Changsha China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07129148 on ClinicalTrials.gov ↗ ← All trials in China