[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06057662":3,"trial-entities:NCT06057662":69,"trial-summary:NCT06057662":73},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":53,"locations":55,"central_contacts":65,"overall_officials":66,"references":67,"see_also_links":68},"NCT06057662","2059749","Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes","Effect of Personalized Comprehensive Diabetes Support Among Families of Children With Newly Diagnosed Type 1 Diabetes","ENROLLING_BY_INVITATION","2027-07-01","2025-12","2025-12-05","2023-08-01","University of California, Davis","OTHER",null,"The goal of this clinical trial is to learn if access to a diabetes coach improves quality of life (QOL) for families of children with newly diagnosed type 1 diabetes. The main questions it aims to answer are:\n\n1. Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention.\n2. Determine if potential beneficial effects persist beyond completion of the support intervention, as measured by diabetes-related QOL at 12 months and 24 months following diagnosis\n\nParticipants assigned to the intervention group will have access to a diabetes coach for 6 months following type 1 diabetes diagnosis. They will be compared to participants who are assigned to the control group and are receiving usual care.",[18],"Type 1 Diabetes",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[23],"NA",{"count":25,"type":26},60,"ESTIMATED",[28],{"type":14,"name":29,"description":29,"armGroupLabels":30},"personalized comprehensive diabetes support",[31],"Intervention",[33,37],{"measure":34,"description":35,"timeFrame":36},"Diabetes Distress Scale","The Distress Scale (DDS) uses a 6-point Likert scale to quantify diabetes-related stress. Scores can range from 0 to 72. A higher score indicates higher distress.","24 months",{"measure":38,"description":39,"timeFrame":36},"Problem Areas in Diabetes (PAID)","The Problem Areas in Diabetes (PAID) uses a 6-point Likert scale to quantify diabetes-related stress. Scores can range from 0 to 100. A higher score indicates higher distress.",[],"ALL","0 Years","16 Years",true,{"inclusion":46,"exclusion":49,"raw_text":52},[47,48],"Families of children 16 years of age or younger with a new diagnosis","Stable living situation such that the same caregivers are anticipated to be caring for the child during the full 2-year study duration.",[50,51],"Families of children older than 16 years","Children from non-English speaking families","Inclusion Criteria:\n\n* Families of children 16 years of age or younger with a new diagnosis\n* Stable living situation such that the same caregivers are anticipated to be caring for the child during the full 2-year study duration.\n\nExclusion Criteria:\n\n* Families of children older than 16 years\n* Children from non-English speaking families",[54],"CHILD",[56],{"facility":57,"city":58,"state":59,"zip":60,"country":61,"geoPoint":62},"University of California Davis","Sacramento","California","95817","United States",{"lat":63,"lon":64},38.58157,-121.4944,[],[],[],[],{"nct_id":4,"conditions":70,"biomarkers":72},[71],"Type 1 Diabetes Mellitus",[],{"nct_id":4,"found":74,"summary":15,"prompt_version":15},false]