[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fear-of-hypoglycemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fear-of-hypoglycemia":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":45,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100609246","precision-subclassification-of-mental-health-in-diabetes-digital-twins-for-precision-mental-health-to-track-subgroups-100609246",false,"NCT07212075","Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups","TwinPeaks","Inclusion Criteria:\n\n* 18 to 80 years of age\n* Diagnosis of type 1 diabetes or type 2 diabetes or other specific type of diabetes\n* Diabetes duration ≥ 1 year\n* Sufficient German language skills\n* Informed consent\n\nExclusion Criteria:\n\n* Inability to consent\n* Significant cognitive impairment (e.g. dementia)\n* Severe disorder or condition impacting the person's ability to participate in the study or likely to confound results (e.g. treated cancer, heart disease ≥ NYHA III, schizophrenia\u002Fpsychotic disorder)\n* Terminal illness\n* Being bedridden","ALL","18 Years","80 Years",{"count":20,"type":21},1809,"ESTIMATED","OBSERVATIONAL","Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health.\n\nBelonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups.\n\nOver 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person.\n\nThe objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions.\n\nTo achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews.\n\nThe complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Diabetes (DM)","Diabete Mellitus","Diabete Type 1","Diabete Type 2","Diabetes Distress","Diabetes Complications","Depression - Major Depressive Disorder","Depression Anxiety Disorder","Depression Bipolar","Depression Disorders","Anxiety Disorder (Panic Disorder or GAD)","Anxiety Disorder NOS","Eating Disorder Binge","Anorexia Nervosa","Bulimia Nervosa","Eating Disorder Not Otherwise Specified","Depressed Mood","Anxiety Symptoms","Disordered Eating Behaviors","Fear of Hypoglycemia",[46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,29,14],"Digital Twin","Precision Medicine","Precision Mental Health","Subclassification","Trajectories","Subtypes","Person-reported Outcomes (PRO)","Ecological Momentary Assessment (EMA)","Continuous Glucose Monitoring (CGM)","People with Diabetes (PWD)","Diabetes Mellitus","HbA1c","Depression","Anxiety","Eating disorder","RECRUITING","2025-11-27",{"date":64,"type":65},"2025-12-04","ACTUAL",{"date":67,"type":65},"2025-01-01",{"date":69,"type":21},"2027-12-31",{"name":71,"class":72},"Forschungsinstitut der Diabetes Akademie Mergentheim","OTHER",3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100551808","effects-of-a-health-intervention-on-fear-of-hypoglycemia-100551808","NCT06464900","Effects of a Health Intervention on Fear of Hypoglycemia","Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Randomized Controlled Study","Inclusion Criteria:\n\n* Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;\n* Age ≥18 years;\n* Duration of diabetes mellitus ≥1 year;\n* FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);\n* Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;\n* Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate;\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;\n* Patients with comorbid psychiatric diseases or taking psychotropic drugs;\n* Patients who have recently or are participating in other studies on similar topics.",{"count":82,"type":21},90,"INTERVENTIONAL",[85],"NA","To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.",[88,89,44,90,91,92],"Health-Related Behavior","Health Education","Impaired Awareness of Hypoglycemia","Self-Management","Type2 Diabetes Mellitus",[94,95,96,97,98,99,100],"Behaviour Change Wheel","Health educational intervention","Fear of hypoglycaemic","Impaired awareness of hypoglycaemia","Medical support","Self-management attitude","Type 2 diabetes mellitus","NOT_YET_RECRUITING","2024-07-07",{"date":104,"type":65},"2024-07-09",{"date":106,"type":21},"2024-07",{"date":108,"type":21},"2025-01",{"name":110,"class":72},"Yangzhou University",1]