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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Shanxi Bethune Hospital
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Change in Glycated Hemoglobin (HbA1c)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Integrated TCM-Western Medicine Intelligent Diabetes Management Platform (Combination Product)
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.
Intervention: Integrated TCM-Western Medicine Intelligent Diabetes Management Platform (Combination Product)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported