RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form (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). Who Should NOT Join This Trial: - Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol. - Children known to have T1D Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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). Exclusion Criteria: * Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol. * Children known to have T1D

Treatments Being Tested

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

Differential Gene Expression (DGE)

Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age

Locations (4)

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