[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638167":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":26,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":26,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":26},{"fullName":5,"class":6},"Yangzhou University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Participants receive an 8-week interoception-integrated adapted mindfulness training program, in addition to routine treatment, examinations, nursing care, and health education.",[13],"Behavioral: Adapted Mindfulness Training",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Participants receive routine treatment, examinations, nursing care, and health education only, without the mindfulness training during the 8-week study period.",[19],"Behavioral: Routine Intervention",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Adapted Mindfulness Training","An 8-week adapted mindfulness program, based on Mindfulness-Based Stress Reduction (MBSR), is delivered to patients with Impaired Awareness of Hypoglycemia (IAH) by a multidisciplinary team. It involves weekly 1-1.5 hour face-to-face group sessions (8-10 participants) and daily home practices supervised via a WeChat group. Tailored to IAH, the curriculum integrates core skills (mindful meditation, yoga, breathing, and walking) with IAH-specific elements. By training self-awareness, attentional control, and emotional regulation, it aims to enhance interoceptive awareness. This strengthens hypoglycemia-related perceptual behaviors, helping patients acquire self-regulation skills, attend to physical sensations of hypoglycemia, perceive nocturnal hypoglycemia, and identify fear of hypoglycemia.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Routine Intervention","The control group receives routine medical care, examinations, nursing, and health education. While they undergo the same follow-up schedule as the intervention group, no mindfulness practice guidance is provided during the study period. Upon the conclusion of the study, mindfulness-related materials will be distributed to these participants.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mengyao Han","Graduate Student","100638167","adapted-mindfulness-training-for-diabetic-patients-with-impaired-hypoglycemia-awareness-100638167",false,"NCT07586527","Adapted Mindfulness Training for Diabetic Patients With Impaired Hypoglycemia Awareness","Impact of Adapted Mindfulness Training Integrating Interoception on Diabetic Patients With Impaired Awareness of Hypoglycemia: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed with type 1 or type 2 diabetes mellitus according to the latest American Diabetes Association (ADA) Standards of Care in Diabetes;\n* Receiving insulin therapy for ≥ 1 year;\n* Age between 18 and 80 years (inclusive);\n* Duration of diabetes ≥ 5 years;\n* Gold score ≥ 4 and Clarke score ≥ 4;\n* Voluntary participation and provision of signed informed consent.\n\nExclusion Criteria:\n\n* Prior experience with mindfulness interventions;\n* Diagnosed with cognitive impairment, psychiatric disorders, or other severe physical comorbidities;\n* Current use of psychotropic medications;\n* Pregnant or lactating women, or women of childbearing potential not using effective contraception.","ALL","18 Years","80 Years",{"count":46,"type":47},100,"ESTIMATED","INTERVENTIONAL",[50],"NA","The purpose of this randomized controlled trial is to evaluate the effectiveness of an 8-week interoception-integrated adapted mindfulness training program for patients with type 1 or type 2 diabetes who experience impaired awareness of hypoglycemia (IAH). The study aims to determine whether this mindfulness intervention, which includes techniques such as body scanning and mindful eating, can help patients better recognize early physiological signals of low blood sugar compared to routine care. Researchers will measure changes in participants' interoceptive awareness and the severity of their IAH over a 3-month follow-up period. The ultimate goal is to provide a practical psychological approach to improve symptom perception and reduce the risk of severe hypoglycemic events in diabetic patients.",[53,54,55],"Impaired Awareness of Hypoglycemia","Interoceptive Awareness","Mindfulness-based Intervention","NOT_YET_RECRUITING","2026-05-08",{"date":59,"type":60},"2026-05-14","ACTUAL",{"date":62,"type":47},"2026-06-01",{"date":64,"type":47},"2027-06-01",{"name":5,"class":6}]