Chronic Disease Management, Diabetes Mellitus, Type 2, Digital Health, Integrated Traditional Chinese Medicine and Western Medicine, Telemedicine
Conditions
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.
Interventions
COMBINATION_PRODUCTIntegrated 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.
Sponsors
Shanxi Bethune Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Target Achievement Rate | 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. |
| Change in Glycated Hemoglobin (HbA1c) | 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) | 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. |
Countries
China
Contacts
Primary ContactShiwei Liu, Doctor
Outcome results
None listed