Mobile Health and Wearable Devices for Diabetes Complication Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device: No specific devices, Device: CGM,CGM management platform, Device: "Professor Tang" WeChat Mini-program, Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus Type 2, Diabetes Mellitus Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on the Applicability of New Technologies for Diabetes Complication Management Based on Mobile Health and Wearable Devices
Overview
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
- Other Device: No specific devices
Routine doctor-patient interaction. - Other Device: CGM,CGM management platform
Wearable monitoring + CGM management platform-assisted administration - Other Device: "Professor Tang" WeChat Mini-program
Mini-program-assisted health management - Other Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program
Wearable monitoring + mini-program integrated management
Primary outcome measures
- HbA1c [Time frame: Baseline, 1 year]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of Type 2 Diabetes;
- Aged ≥ 18 years;
- Able to accept the diabetes management model with AI-assisted management and wearable device monitoring;
- Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.;
- 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
- Having severe mental illness or language barriers;
- Suffering from malignant tumors;
- Pregnant or lactating women;
- Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.);
- 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);
- A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy;
- Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases;
- Alcoholism or drug addiction;
- Receiving insulin therapy;
- Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Second Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT07129148 · LYEC2024-0331