[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613319":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":28,"centralContacts":29,"locations":36,"responsibleParty":56,"collaborators":28,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":28,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":28,"enrollmentInfo":67,"targetDuration":28,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":28,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Shanxi Bethune Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"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\u002Freminders (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.",[12],"Combination Product: Integrated TCM-Western Medicine Intelligent Diabetes Management Platform",{"label":14,"type":6,"description":15,"interventionNames":16},"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\u002For 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.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"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, 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.",[14,9],[24,25,26,27],"Intelligent TCM-WM Diabetes Management System","Digital Integrated Care Platform for Diabetes","Telemedicine-based TCM-WM Collaborative Care","AI-Supported Diabetes Management",null,[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Shiwei Liu, Doctor","CONTACT","+86 13191072733","0351-2170956","lswspring6@aliyun.com",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Taiyuan","Shanxi","030000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],112.56028,37.86944,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":54,"email":55},"Chen Li, Master","13603530358","0351-8379146","chenli253@163.com",{"type":57,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100613319","integrated-tcm---western-medicine-strategy-for-long---distance-diabetes-management-100613319",false,"NCT07265037","Integrated TCM - Western Medicine Strategy for Long - Distance Diabetes Management","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","Inclusion Criteria:\n\n* 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\u002FL, or Random plasma glucose ≥ 11.1 mmol\u002FL, or Glycated hemoglobin (HbA1c) ≥ 6.5%.\n* OR, meeting the following oral glucose tolerance test criteria:Fasting plasma glucose ≥ 7.0 mmol\u002FL AND 2-hour plasma glucose ≥ 11.1 mmol\u002FL after a 75g glucose load.\n\nExclusion Criteria:\n\n* 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.","ALL","18 Years",{"count":68,"type":69},10000,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.\n\nBased 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\".\n\nThis 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.",[75,76,77,78,79],"Diabetes Mellitus, Type 2","Integrated Traditional Chinese Medicine and Western Medicine","Telemedicine","Chronic Disease Management","Digital Health","2025-11-23",{"date":82,"type":83},"2025-12-04","ACTUAL",{"date":85,"type":83},"2025-11-01",{"date":87,"type":69},"2026-05-31",{"name":5,"class":6},1]