[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553621":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":64,"collaborators":67,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":36,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":36,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":96,"whyStopped":36,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention","EXPERIMENTAL","The interventions will be provided at regular intervals of 2 months and adherence to the interventions will be monitored. The children along with the caregivers will attend the Endocrinology OPD where they will be educated as per prepared modules by the diabetic educators and will be monitored for adherence to diet and insulin. They will also be directed to the Child Psychologist to give module- based interventions. The interventions will be provided for a period of 6 months. Follow up of patients for reinforcement of interventions will happen on 2-monthly basis.",[13],"Behavioral: Psychological Interventions for children and adolescents",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","ACTIVE_COMPARATOR","Routine standard of care is given to all patients with Hypoglycemia unawareness, irrespective of the randomized group to which they belong. This include treatment of hypoglycaemia, mandatory avoidance of hypoglycaemia for 2 weeks, Review of drugs and diet every 3 months (which is routinely done at our centre) and exploring the causes of hypoglycaemia. The control group will receive education on Dietary modification, advise on individualized targets and warning signs of hypoglycemia.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Psychological Interventions for children and adolescents","Psychological Interventions for children and adolescents:\n\n* Behavioral modifications using Functional Analysis and Parent Management Techniques\n* Illness Management behavior - Motivational Interviewing, Cognitive Therapy to identify thinking errors posing challenges to self-management, Behavioral Modification to enhance self-management of illness, Solution focused therapy to manage identified barriers in illness -management\n* Managing emotional problems- Cognitive Behavioral Therapy techniques\n\nPsychological Interventions for Parents\u002F Caregivers:\n\n* Parent management techniques- Identification of problem behaviors\u002Fdeficit\n* Education on Dysfunctional attitude and their effects Psycho-education for Children could be delivered best in Combined with Health Education and Nutritional education leading to dietary modifications.\n* Individualized Treatment targets and Resetting targets",[15,9],[26,27],"Psychological Interventions for Parents\u002F Caregivers","Psycho-education for Children could be delivered best in Combined with Health Education and Nutritional education leading to dietary modifications",[29],{"name":30,"affiliation":5,"role":31},"Vishwajit L Nimgaonkar, MD, PhD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","4127265164",null,"vishwajitnl@upmc.edu",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Triptish Bhatia, PhD","+919910107210","trb16@pitt.edu",[43],{"facility":44,"status":36,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Believers Church Medical College","Tiruvalla","Kerala","689 103","India","IN",{"type":51,"coordinates":52},"Point",[53,54],76.57489,9.3816,{"lat":54,"lon":53},[57,60],{"name":58,"role":34,"phone":40,"phoneExt":36,"email":59},"Sangeetha M Varghese, MD","sangjithin2011@gmail.com",{"name":61,"role":34,"phone":62,"phoneExt":36,"email":63},"Pradeep Johnson, MD","+917892673938","johnson.pr@stjohns.in",{"type":31,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Vishwajit Nimgaonkar, MD PhD","Professor",[68,71],{"name":69,"class":70},"Fogarty International Center of the National Institute of Health","NIH",{"name":72,"class":73},"Believers Church Medical College, Thiruvalla, Kerala, India.","UNKNOWN","100553621","behavioural-problems-and-cognition-in-children-with-hypoglycemia-unawareness-in-type-1-diabetes-mellitus-100553621",false,"NCT06488469","Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus","The Effect of a Multi-domain Intervention on the Behaviour Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus- A Pilot Study","Inclusion Criteria:\n\n* Children should be between 6-16 years of age.\n* Children must be having Hypoglycemia Unawareness as documented by Continuous Glucose Monitoring. (Blood sugar \\\u003C70 mg\u002Fdl without symptoms)\n* Children must be on treatment with Insulin for a minimum period of 6 months\n* The care giver\u002Fparent must give written informed consent for the child and himself\u002Fherself and the child should give assent.\n\nExclusion Criteria:\n\n* Children with known psychiatric disorders.\n* Children who are on steroids and\n* Children with documented Learning Disability from a certified psychologist.","ALL","6 Years","16 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[89],"NA","The study is designed to explore if a multi-pronged intervention strategy comprising of Psychological Interventions, Dietary Modifications, Targeted therapy and Counselling on Parental Attitude would bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.",[92],"Type 1 Diabetes",[94,92,95],"Hypoglycemia","Parent management techniques","NOT_YET_RECRUITING","2026-07-06",{"date":99,"type":100},"2026-07-07","ACTUAL",{"date":102,"type":86},"2026-12-01",{"date":104,"type":86},"2028-07-31",{"name":5,"class":6},1]