Mobile Health and Wearable Devices for Diabetes Complication Management
Study on the Applicability of New Technologies for Diabetes Complication Management Based on Mobile Health and Wearable Devices
1 other identifier
interventional
1,600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Oct 2025
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2025
CompletedFirst Posted
Study publicly available on registry
August 19, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
August 19, 2025
August 1, 2025
1 year
August 6, 2025
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
Between-group differences in HbA1c change (from Central Lab)
Baseline, 1 year
Study Arms (4)
Control: Traditional Control
OTHERAdopt classic doctor-patient interaction management; receive diet and exercise education upon enrollment, self-monitor blood glucose at home and keep a diary.
Experimental: Wearable Devices + Data Management Platform
OTHEROn the basis of classic management, wear CGM , load CGM management software, and monitor health data in real time via mobile software.
Experimental:WeChat mini-program Smart Management
OTHEROn the basis of classic management, use the "Professor Tang" WeChat mini-program for blood glucose recording and diet/exercise management.
Experimental:Wearable Devices + WeChat mini-program Management
OTHEROn 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.
Interventions
Wearable monitoring + CGM management platform-assisted administration
Mini-program-assisted health management
Wearable monitoring + mini-program integrated management
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Xiangya Hospital of Central South Universitylead
- First Hospital of China Medical Universitycollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- First Affiliated Hospital of Harbin Medical Universitycollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- First Affiliated Hospital of Kunming Medical Universitycollaborator
- Tianjin Medical University Chu Hsien-I Memorial Hospitalcollaborator
- Shanghai 6th People's Hospitalcollaborator
- Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campuscollaborator
- Sinocarecollaborator
Study Sites (1)
Second Xiangya Hospital of Central South University
Changsha, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2025
First Posted
August 19, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share