Integrated TCM - Western Medicine Strategy for Long - Distance Diabetes Management
NCT ID: NCT07265037
Last Updated: 2025-12-04
Study Results
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Basic Information
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RECRUITING
NA
10000 participants
INTERVENTIONAL
2025-11-01
2026-05-31
Brief Summary
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Based on this, our research group plans to rely on the pre - designed and developed Idata database. We will deeply integrate the diagnostic and treatment advantages of TCM constitution differentiation and Western medical examinations and laboratory tests, construct an automated follow - up path, and build an integrated online diabetes management platform for Internet hospitals, which consists of "intelligent hardware + APP + cloud services + a back - end think - tank of TCM and Western medicine experts + a back - end professional management and care team".
This initiative aims to blaze a new trail in the field of long - distance, full - course, and personalized management of diabetes through the synergy of TCM and Western medicine for Chinese diabetes patients. We expect to significantly reduce the incidence of diabetes complications, remarkably improve the overall health status and quality of life of patients, and bring unprecedented positive impacts on the well - being of diabetes patients.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Integrated TCM-WM Smart Management Group
Participants receive a novel integrated diabetes management strategy via a smart platform (hardware + APP + cloud). This includes TCM-WM baseline assessments, personalized remote monitoring/reminders (glucose, medication, lifestyle), tailored TCM-WM education, and backend multidisciplinary expert support. The management pathway is dynamically optimized every 3 months based on continuous data analysis.
Integrated TCM-Western Medicine Intelligent Diabetes Management Platform
This intervention is a comprehensive, technology-enabled management strategy. It utilizes an integrated smart platform comprising connected devices (e.g., glucose meters, blood pressure monitors), a mobile application (APP), and cloud services. Participants undergo an initial combined assessment based on Western medicine examinations and Traditional Chinese Medicine (TCM) constitution diagnosis (via questionnaire and tongue image analysis). The platform's algorithms then generate a personalized, automated remote management pathway. This includes customized reminders for monitoring, medication, and follow-ups; tailored lifestyle and health education advice integrating TCM and WM principles; and access to daily online consultations from a backend multidisciplinary expert team (endocrinologists, TCM physicians, nutritionists). The management plan is dynamically optimized every 3 months based on continuous data analysis, forming a closed-loop management system.
Conventional Care Group
Participants in this arm receive current standard conventional care for diabetes mellitus. This includes regular outpatient follow-ups by endocrinologists, standard pharmacological therapy (e.g., oral hypoglycemic agents and/or insulin) based on authoritative clinical guidelines such as those from the Chinese Diabetes Society, and routine diabetes health education (e.g., diet and exercise advice) provided by healthcare professionals. Participants in this group do NOT have access to the investigational smart management platform (APP, connected devices), nor do they receive the personalized reminders, remote consultations, integrated TCM-WM management pathway, or proactive management from the backend multidisciplinary team that are part of the intervention. Their care process adheres to the usual practices of their respective medical centers.
Integrated TCM-Western Medicine Intelligent Diabetes Management Platform
This intervention is a comprehensive, technology-enabled management strategy. It utilizes an integrated smart platform comprising connected devices (e.g., glucose meters, blood pressure monitors), a mobile application (APP), and cloud services. Participants undergo an initial combined assessment based on Western medicine examinations and Traditional Chinese Medicine (TCM) constitution diagnosis (via questionnaire and tongue image analysis). The platform's algorithms then generate a personalized, automated remote management pathway. This includes customized reminders for monitoring, medication, and follow-ups; tailored lifestyle and health education advice integrating TCM and WM principles; and access to daily online consultations from a backend multidisciplinary expert team (endocrinologists, TCM physicians, nutritionists). The management plan is dynamically optimized every 3 months based on continuous data analysis, forming a closed-loop management system.
Interventions
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Integrated TCM-Western Medicine Intelligent Diabetes Management Platform
This intervention is a comprehensive, technology-enabled management strategy. It utilizes an integrated smart platform comprising connected devices (e.g., glucose meters, blood pressure monitors), a mobile application (APP), and cloud services. Participants undergo an initial combined assessment based on Western medicine examinations and Traditional Chinese Medicine (TCM) constitution diagnosis (via questionnaire and tongue image analysis). The platform's algorithms then generate a personalized, automated remote management pathway. This includes customized reminders for monitoring, medication, and follow-ups; tailored lifestyle and health education advice integrating TCM and WM principles; and access to daily online consultations from a backend multidisciplinary expert team (endocrinologists, TCM physicians, nutritionists). The management plan is dynamically optimized every 3 months based on continuous data analysis, forming a closed-loop management system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* OR, meeting the following oral glucose tolerance test criteria:Fasting plasma glucose ≥ 7.0 mmol/L AND 2-hour plasma glucose ≥ 11.1 mmol/L after a 75g glucose load.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Shanxi Bethune Hospital
OTHER
Responsible Party
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Locations
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Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXLL-2025-260
Identifier Type: -
Identifier Source: org_study_id
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