Diabetes Mellitus, Type 2NCT07265037
Integrated TCM - Western Medicine Strategy for Long - Distance Diabetes Management
A study testing Integrated TCM-Western Medicine Intelligent Diabetes Management Platform in people with Diabetes Mellitus, Type 2 and Integrated Traditional Chinese Medicine and Western Medicine, run by Shanxi Bethune Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Integrated Traditional Chinese Medicine and Western Medicine, Telemedicine
- What is being tested?
- Integrated TCM-Western Medicine Intelligent Diabetes Management Platform
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
Chen Li, Master, 13603530358 ext. 0351-8379146, chenli253@163.com
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2, Integrated Traditional Chinese Medicine and Western Medicine, Telemedicine, Chronic Disease Management, Digital Health
- Being tested
- Integrated TCM-Western Medicine Intelligent Diabetes Management Platform
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated TCM-Western Medicine Intelligent Diabetes Management PlatformCombination product
Also called Intelligent TCM-WM Diabetes Management System, Digital Integrated Care Platform for Diabetes, Telemedicine-based TCM-WM Collaborative Care, AI-Supported Diabetes Management
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated TCM-WM Smart Management Group | Other | 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. Receives: Combination Product: Integrated TCM-Western Medicine Intelligent Diabetes Management Platform |
| Conventional Care Group | Other | 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. Receives: Combination Product: Integrated TCM-Western Medicine Intelligent Diabetes Management Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c)
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.
Measured: Baseline to 6 Months
Percentage of Time in Blood Glucose Target Range (TIR)
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.
Measured: Baseline to 6 Months
Glycemic Target Achievement Rate
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.
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Nov 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265037
- Sponsor's protocol ID
- YXLL-2025-260
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The current study protocol does not include a plan to make individual participant data (IPD) publicly available. Data sharing may be considered in the future based on institutional policies and upon reasonable request subject to review and approval.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07265037
- Acronym / sponsor ID
- YXLL-2025-260
- Conditions
- Diabetes Mellitus, Type 2, Integrated Traditional Chinese Medicine and Western Medicine, Telemedicine, Chronic Disease Management, Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated TCM-WM Smart Management Group | Other | Combination Product: Integrated TCM-Western Medicine Intelligent Diabetes Management PlatformParticipants 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. |
| Conventional Care Group | Other | Combination Product: Integrated TCM-Western Medicine Intelligent Diabetes Management PlatformParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated TCM-Western Medicine Intelligent Diabetes Management PlatformAlso: Intelligent TCM-WM Diabetes Management System, Digital Integrated Care Platform for Diabetes, Telemedicine-based TCM-WM Collaborative Care, AI-Supported Diabetes ManagementThis 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. | Combination product | Conventional Care Group, Integrated TCM-WM Smart Management Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No. The current study protocol does not include a plan to make individual participant data (IPD) publicly available. Data sharing may be considered in the future based on institutional policies and upon reasonable request subject to review and approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated TCM-Western Medicine Intelligent Diabetes Management Platform in people with Diabetes Mellitus, Type 2 and Integrated Traditional Chinese Medicine and Western Medicine, run by Shanxi Bethune Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiwei Liu, Doctor (+86 13191072733 ext. 0351-2170956, lswspring6@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) (time frame: Baseline to 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.