[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04477928":3,"trial-entities:NCT04477928":168,"trial-summary:NCT04477928":173},{"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":21,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":36,"interventions":39,"primary_outcomes":50,"secondary_outcomes":55,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":88,"locations":90,"central_contacts":157,"overall_officials":159,"references":162,"see_also_links":167},"NCT04477928","PLEDGE","General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery","Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children","RECRUITING","2031-03","2026-02","2026-03-02","2020-07-17","Sanford Health","OTHER",false,"In partnership with Helmsley Charitable Trust, the Sanford PLEDGE Study is a large-scale, observational, feasibility study of general population screening for T1D and celiac autoantibodies. Screening is incorporated into routine health care visits within an integrated health system.","Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often are not diagnosed until the child is very sick. Research suggests that screening and identifying children at risk for T1D autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes.\n\nThe investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (T1D), or referred to clinical care (celiac).",[19,20],"Type 1 Diabetes","Celiac Disease",[22,19,20,23,24,25,26,27,28,29,30,31,32],"Population screening","Autoantibodies","Prevention","Diabetic Ketoacidosis (DKA)","Genetic Risk Score","Differential Gene Expression","Economic Modeling","Quality of Life","Feasibility","Pragmatic","T1D","OBSERVATIONAL",null,[],{"count":37,"type":38},33000,"ESTIMATED",[40,46],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DIAGNOSTIC_TEST","Sera and whole blood sampling","* Study Entry: Single Nucleotide Polymorphism (SNP)-Based Genetic Risk Score at study entry.\n* 2 years old: T1D autoantibodies, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies\n* 5 years old: T1D and celiac autoantibodies\n* 9-16 year old: one-time T1D and celiac autoantibodies\n* Siblings of people with T1D autoimmunity, ages 6-17 years: one-time T1D and celiac autoantibodies",[45],"Study Group",{"type":41,"name":47,"description":48,"armGroupLabels":49},"Differential Gene Expression (DGE)","Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age",[45],[51],{"measure":52,"description":53,"timeFrame":54},"Demonstrated feasibility of large-scale population screening, as evidenced by:","1. The percentage of parent(s) that viewed the MyChart study information who went on to complete the MyChart informed consent, HIPAA and questionnaires.\n2. Of those who consented to be in the study, the percentage who went on to obtain the initial sample.\n3. Of the total samples collected, percentage that were valid and results received.\n4. The percentage of subjects who complete their \\~60 month visit by their 6th birthday.","By year 10 of the study",[56,59,61,63,65,67,69,71],{"measure":57,"timeFrame":58},"Seroconversion rates for T1D-relevant and celiac autoantibodies","By year 10 of study",{"measure":60,"timeFrame":58},"Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.",{"measure":62,"timeFrame":58},"Percentage of celiac seropositive subjects referred on to GI or primary care",{"measure":64,"timeFrame":58},"The percentage of celiac seropositive subjects who were evaluated in clinical setting",{"measure":66,"timeFrame":58},"The rate of development of overt hyperglycemia consistent with T1D (Stage 3).",{"measure":68,"timeFrame":58},"Proportion of participants developing overt hyperglycemia consistent with T1D (Stage 3), who present in diabetic ketoacidosis (DKA)",{"measure":70,"timeFrame":58},"Number and type of procedure-related adverse events",{"measure":72,"timeFrame":58},"Assessment of costs associated with implementation of study compared to potential impacts on cost and quality of life.","ALL","0 Minutes","17 Years",true,{"inclusion":78,"exclusion":84,"raw_text":87},[79,80,81,82,83],"Newborn Entry: Viable, term infants, defined as 36 weeks gestation by either dates or ultrasound who are born to pregnant women, 18 years or older, who are willing and able to provide informed consent (IC) prior to the onset of active labor. Who are born at a Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic","Pediatric Entry: Children less than 6 years of age who receive their routine care at a Sanford facility and whose parents are able to provide IC.","Adolescent Entry: Children, ages 9-16 years old, who receive their routine care at a Sanford facility and whose parents are able to provide IC.","Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who receive care at a Sanford clinic","Have an active MyChart account (with proxy access).",[85,86],"Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.","Children known to have T1D","Inclusion Criteria:\n\n* Newborn Entry: Viable, term infants, defined as 36 weeks gestation by either dates or ultrasound who are born to pregnant women, 18 years or older, who are willing and able to provide informed consent (IC) prior to the onset of active labor. Who are born at a Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic\n* Pediatric Entry: Children less than 6 years of age who receive their routine care at a Sanford facility and whose parents are able to provide IC.\n* Adolescent Entry: Children, ages 9-16 years old, who receive their routine care at a Sanford facility and whose parents are able to provide IC.\n* Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who receive care at a Sanford clinic\n* Have an active MyChart account (with proxy access).\n\nExclusion Criteria:\n\n* Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.\n* Children known to have T1D",[89],"CHILD",[91,109,120,131],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":106},"Sanford Bemidji Region Clinics","Bemidji","Minnesota","56601","United States",[98,103],{"name":99,"role":100,"phone":101,"email":102},"Ann Mays, RN, CPN","CONTACT","605-312-6052","ann.mays@sanfordhealth.org",{"name":104,"role":105},"Kurt Griffin, PhD, MD","PRINCIPAL_INVESTIGATOR",{"lat":107,"lon":108},47.47356,-94.88028,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":96,"contacts":114,"geoPoint":117},"Sanford Bismarck Region Clinics","Bismarck","North Dakota","58501",[115,116],{"name":99,"role":100,"phone":101,"email":102},{"name":104,"role":105},{"lat":118,"lon":119},46.80833,-100.78374,{"facility":121,"status":8,"city":122,"state":112,"zip":123,"country":96,"contacts":124,"geoPoint":128},"Sanford Fargo Region Clinics","Fargo","58112",[125,127],{"name":126,"role":100,"phone":101,"email":102},"Ann Mays",{"name":104,"role":105},{"lat":129,"lon":130},46.87719,-96.7898,{"facility":132,"status":8,"city":133,"state":134,"zip":135,"country":96,"contacts":136,"geoPoint":154},"Sanford Sioux Falls Region Clinics","Sioux Falls","South Dakota","57105",[137,139,140,143,145,147,149,151,153],{"name":126,"role":100,"phone":138,"email":102},"6053126052",{"name":104,"role":105},{"name":141,"role":142},"Sharon Hunt, BS, MS, MBA","SUB_INVESTIGATOR",{"name":144,"role":142},"Candice Nelson, MD, FAAP",{"name":146,"role":142},"Stephanie Hanson, MD, FAAP",{"name":148,"role":142},"Louis Casas, MD, FAAP",{"name":150,"role":142},"Brenda Thurlow, MD, FAAP",{"name":152,"role":142},"Kyle Baum, MD",{"name":99,"role":142},{"lat":155,"lon":156},43.54369,-96.72796,[158],{"name":99,"role":100,"phone":101,"email":102},[160],{"name":104,"affiliation":161,"role":105},"Sanford Research",[163],{"pmid":164,"type":165,"citation":166},"35316839","BACKGROUND","Sims EK, Besser REJ, Dayan C, Geno Rasmussen C, Greenbaum C, Griffin KJ, Hagopian W, Knip M, Long AE, Martin F, Mathieu C, Rewers M, Steck AK, Wentworth JM, Rich SS, Kordonouri O, Ziegler AG, Herold KC; NIDDK Type 1 Diabetes TrialNet Study Group. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes. 2022 Apr 1;71(4):610-623. doi: 10.2337\u002Fdbi20-0054.",[],{"nct_id":4,"conditions":169,"biomarkers":171},[20,170],"Type 1 Diabetes Mellitus",[172],"T1D-relevant antibodies",{"nct_id":4,"found":76,"summary":174,"prompt_version":184},{"design":175,"status":176,"heading":177,"summary":178,"follow_up":179,"word_count":180,"commitments":181,"compensation":182,"drugs_mentioned":183},"This is an observational study planning to enroll 33,000 participants. It is not a randomized or blinded study.","completed","Sanford PLEDGE Study: Type 1 Diabetes and Celiac Disease Risk Screening","This observational study, called the Sanford PLEDGE Study, is looking at how well we can screen children for their risk of developing Type 1 Diabetes (T1D) and Celiac Disease during their regular doctor visits. Researchers will collect blood samples at different ages (birth, 2, 5, or between 9-16 years old) to check for specific markers (autoantibodies) related to these conditions. Some participants may also have additional genetic testing. The main goal is to see if this large-scale screening is practical and can be done effectively. This study is currently recruiting children from birth up to 17 years old.","The feasibility of large-scale screening will be measured by year 10 of the study.",98,"Participants will have blood samples taken during routine healthcare visits at specific ages (birth, 1, 2, 5 years, or once between 9 and 16 years). Some may also have cord blood and peripheral blood samples taken for genetic testing.","Not stated in the trial record.",[],"v2"]