Mobile health and wearables to help manage and prevent diabetes complications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will evaluate whether an AI model using phenotype data, lab results, and wearable device indicators can predict the risk of type 2 diabetes complications. It will also explore whether an intelligent lifestyle intervention delivered through wearables and a smartphone app can prevent or reduce complications. Participants will use AI-assisted management and receive CGM monitoring, a smart bracelet, and the Professor Tang WeChat mini-program as part of the intervention over a 3-month period. The study is led by Second Xiangya Hospital with several collaborating centers in China. It does not specify a parallel control group in the provided details.

Why it matters

Who can join: the full rules

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.).

Where it's running

• Second Xiangya Hospital of Central South University
  Changsha, China Recruiting

Study contacts

• Study coordinator: HouDe Zhou, Prof.
• Email: houdezhou@csu.edu.cn
• Phone: 86-0731-85292223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.