[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06906653":3,"trial-entities:NCT06906653":95,"trial-summary:NCT06906653":99},{"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":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":44,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":78,"locations":81,"central_contacts":91,"overall_officials":92,"references":93,"see_also_links":94},"NCT06906653","2220224","Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy","Population Health Management for Kaiser Permanente Northern California (KPNC) Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy","ENROLLING_BY_INVITATION","2027-06","2025-03","2025-04-02","2025-04","Kaiser Permanente","OTHER",false,"This study is a 2-arm randomized trial of Augmented Initial Type 2 Diabetes (T2D) Care vs. Usual Initial T2D Care among adults (18-74 years) with newly diagnosed T2D who have risk factors (defined by age and diagnosis HbA1c value) for suboptimal early glycemic control. Augmented Initial T2D Care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. The study team will use electronic health record (EHR) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.",null,[19,20,21],"Type 2 Diabetes","Type 2 Diabetes Mellitus (T2DM)","Type 2 Diabetes (T2D)",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[26],"NA",{"count":28,"type":29},204,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Augmented Initial Type 2 Diabetes Care","The intervention will include 4 components: 1) Making primary care providers (PCPs) aware that the patient has been selected to receive \"Augmented Initial Type 2 Diabetes (T2D) Care\", 2) encouraging early care manager outreach to establish care, ensure prescribing of appropriate medications, and support medication adherence, 3) a one-on-one virtual health educator visit to reinforce self-management education and ensure set-up of remote glucose monitoring or continuous glucose monitoring (if eligible), and 4) a one-on-one virtual nutrition visit to provide individualized counseling.",[36],"Augmented Initial Type 2 Diabetes (T2D) Care",[38,42],{"measure":39,"description":40,"timeFrame":41},"Average hemoglobin A1c (HbA1c)","Between-arm differences in HbA1c","6-months",{"measure":39,"description":40,"timeFrame":43},"12-months",[45,47,48,51,52,55,56,59,60,63],{"measure":46,"timeFrame":41},"Time to achievement of glycemic targets",{"measure":46,"timeFrame":43},{"measure":49,"description":50,"timeFrame":41},"Adherence to HbA1c monitoring","Number of participants with a new HbA1c laboratory value",{"measure":49,"description":50,"timeFrame":43},{"measure":53,"description":54,"timeFrame":41},"Type 2 diabetes medication and statin initiation","Number of participants who are prescribed a type 2 diabetes medication and\u002For statin",{"measure":53,"description":54,"timeFrame":43},{"measure":57,"description":58,"timeFrame":41},"Type 2 diabetes medication adherence","Proportion of days covered since initiation",{"measure":57,"description":58,"timeFrame":43},{"measure":61,"description":62,"timeFrame":41},"Completion of preventative screening","Number of participants who complete retinal and microalbuminuria screening",{"measure":61,"description":62,"timeFrame":43},"ALL","18 Years","74 Years",{"inclusion":68,"exclusion":74,"raw_text":77},[69,70,71,72,73],"Age 18-74 years","Newly diagnosed with type 2 diabetes","Kaiser Permanente Northern California member receiving care in a participating service area","If age ≤45 years, then HbA1c\\>8%","If age\\\u003C45 years, then HbA1c\\>10%",[75,76],"Individuals who are pregnant","Individuals with likely type 1 diabetes (T1D)","Inclusion Criteria:\n\n* Age 18-74 years\n* Newly diagnosed with type 2 diabetes\n* Kaiser Permanente Northern California member receiving care in a participating service area\n* If age ≤45 years, then HbA1c\\>8%\n* If age\\\u003C45 years, then HbA1c\\>10%\n\nExclusion Criteria:\n\n* Individuals who are pregnant\n* Individuals with likely type 1 diabetes (T1D)",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Kaiser Permanente Division of Research","Pleasanton","California","94588","United States",{"lat":89,"lon":90},37.66243,-121.87468,[],[],[],[],{"nct_id":4,"conditions":96,"biomarkers":98},[97],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]