Mobile Health and Wearable Devices for Diabetes Complication Management
NCT ID: NCT07129148
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1600 participants
INTERVENTIONAL
2025-10-01
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control: Traditional Control
Adopt classic doctor-patient interaction management; receive diet and exercise education upon enrollment, self-monitor blood glucose at home and keep a diary.
Device: No specific devices
Routine doctor-patient interaction.
Experimental: Wearable Devices + Data Management Platform
On the basis of classic management, wear CGM , load CGM management software, and monitor health data in real time via mobile software.
Device: CGM,CGM management platform
Wearable monitoring + CGM management platform-assisted administration
Experimental:WeChat mini-program Smart Management
On the basis of classic management, use the "Professor Tang" WeChat mini-program for blood glucose recording and diet/exercise management.
Device: "Professor Tang" WeChat Mini-program
Mini-program-assisted health management
Experimental:Wearable Devices + WeChat mini-program Management
On the basis of classic management, wear CGM or smartbands , and use the "Professor Tang" WeChat mini-program simultaneously for real-time data monitoring and personalized recommendations.
Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program
Wearable monitoring + mini-program integrated management
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.).
18 Years
ALL
No
Sponsors
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First Hospital of China Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Tianjin Medical University Chu Hsien-I Memorial Hospital
UNKNOWN
Shanghai 6th People's Hospital
OTHER
Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
UNKNOWN
Sinocare
INDUSTRY
Second Xiangya Hospital of Central South University
OTHER
Responsible Party
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Locations
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Second Xiangya Hospital of Central South University
Changsha, , China
Countries
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Central Contacts
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Other Identifiers
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LYEC2024-0331
Identifier Type: -
Identifier Source: org_study_id
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