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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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Contact Information
Primary
Shiwei Liu, Doctor
lswspring6@aliyun.com
+86 13191072733
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 10000
Treatments
Other: 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.
Other: 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.
Related Therapeutic Areas
Sponsors
Leads: Shanxi Bethune Hospital

This content was sourced from clinicaltrials.gov