Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000, China
Location status: Recruiting
Recruiting
NCT Number: NCT07265037
Integrated TCM - Western Medicine Strategy for Long - Distance Diabetes Management
The management of diabetes is of great value in reducing the risk of complications and alleviating the socioeconomic burden. Currently, the diabetes management models in China have not effectively integrated the advantages of traditional Chinese medicine (TCM) and Western medicine. They also fail to achieve intelligent and automated management, resulting in high management costs and low efficiency. Therefore, it is extremely urgent to explore a new, efficient, convenient, low - cost, and personalized long - distance, full - course, intelligent management model for diabetes that integrates TCM and Western medicine both online and offline.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Presence of typical diabetes symptoms (polyuria, polydipsia, polyphagia, and unexplained weight loss) AND meeting any one of the following laboratory criteria: Fasting venous plasma glucose ≥ 7.0 mmol/L, or Random plasma glucose ≥ 11.1 mmol/L, or Glycated hemoglobin (HbA1c) ≥ 6.5%.
- 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
- Comorbidities that may prevent compliance with the study protocol, including but not limited to: active malignancy, rheumatic autoimmune diseases, severe infections, multiple organ failure, or psychiatric disorders.
Treatment and study plan
Integrated TCM-Western Medicine Intelligent Diabetes Management Platform
Combination ProductThis 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 names: Intelligent TCM-WM Diabetes Management System, Digital Integrated Care Platform for Diabetes, Telemedicine-based TCM-WM Collaborative Care, AI-Supported Diabetes Management
Primary outcomes
-
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline to 6 Months
HbA1c reflects average blood glucose levels over the preceding 2-3 months. This outcome measures the absolute change in HbA1c percentage (%) from baseline to the end of the 6-month study period. A larger reduction indicates improved long-term glycemic control.
-
Percentage of Time in Blood Glucose Target Range (TIR)
Time frame: Baseline to 6 Months
Time in Range (TIR) is the percentage of time that a patient's glucose levels remain within a specified target range (3.9-10.0 mmol/L) over a period of time, as measured by continuous glucose monitoring (CGM) or frequent self-monitoring. This outcome assesses the TIR over the entire 6-month intervention period. A higher TIR percentage indicates more stable glucose control and is associated with a reduced risk of diabetes complications.
-
Glycemic Target Achievement Rate
Time frame: Baseline to 6 Months
This outcome measures the proportion of participants who achieve their individualized HbA1c treatment goal (e.g., HbA1c <7.0% for most adults) at the 6-month study endpoint. Achievement is defined based on the latest clinical guidelines and individualized patient factors.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shanxi Bethune Hospital
Other
Registry information
Official study title
Development of a New Integrated Strategy for Long-Distance and Full-Course Management of Diabetes Using Both Traditional Chinese and Western Medicine: A Combined Online and Offline Approach
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 4, 2025
- Registry last updated
- Dec 4, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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