General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
NCT ID: NCT04477928
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
33000 participants
OBSERVATIONAL
2020-07-17
2031-03-31
Brief Summary
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Detailed Description
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The 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).
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Study Group
Children receiving routine care at a Sanford facility
Sera and whole blood sampling
* Study Entry: Single Nucleotide Polymorphism (SNP)-Based Genetic Risk Score at study entry.
* 2 years old: T1D autoantibodies, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies
* 5 years old: T1D and celiac autoantibodies
* 9-16 year old: one-time T1D and celiac autoantibodies
* Siblings of people with T1D autoimmunity, ages 6-17 years: one-time T1D and celiac autoantibodies
Differential Gene Expression (DGE)
Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age
Interventions
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Sera and whole blood sampling
* Study Entry: Single Nucleotide Polymorphism (SNP)-Based Genetic Risk Score at study entry.
* 2 years old: T1D autoantibodies, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies
* 5 years old: T1D and celiac autoantibodies
* 9-16 year old: one-time T1D and celiac autoantibodies
* Siblings of people with T1D autoimmunity, ages 6-17 years: one-time T1D and celiac autoantibodies
Differential Gene Expression (DGE)
Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Children known to have T1D
0 Minutes
17 Years
ALL
Yes
Sponsors
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The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Pacific Northwest Research Institute
OTHER
University of Exeter
OTHER
Sanford Health
OTHER
Responsible Party
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Principal Investigators
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Kurt Griffin, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Sanford Research
Locations
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Sanford Bemidji Region Clinics
Bemidji, Minnesota, United States
Sanford Bismarck Region Clinics
Bismarck, North Dakota, United States
Sanford Fargo Region Clinics
Fargo, North Dakota, United States
Sanford Sioux Falls Region Clinics
Sioux Falls, South Dakota, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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/dbi20-0054.
Other Identifiers
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PLEDGE
Identifier Type: -
Identifier Source: org_study_id
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