NCT07129148 Mobile Health and Wearable Devices for Diabetes Complication Management
| NCT ID | NCT07129148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Diabetes Mellitus Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,000 participants in total. It began in 2025-10-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07129148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07129148 currently recruiting?
Yes, NCT07129148 is actively recruiting participants. Contact the research team at houdezhou@csu.edu.cn for enrollment information.
Where is the NCT07129148 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT07129148 clinical trial?
NCT07129148 is sponsored by Second Xiangya Hospital of Central South University. The trial plans to enroll 6,000 participants.
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