Integrated TCM - Western Medicine Strategy for Long - Distance Diabetes Management

Official 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

Overview

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.

Interventions

• Combination product 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,

Primary outcome measures

• Change in Glycated Hemoglobin (HbA1c) [Time frame: Baseline to 6 Months]
• Percentage of Time in Blood Glucose Target Range (TIR) [Time frame: Baseline to 6 Months]
• Glycemic Target Achievement Rate [Time frame: Baseline to 6 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

China · 1 center

• Shanxi Bethune Hospital — Taiyuan

Identifiers

NCT: NCT07265037 · YXLL-2025-260

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗