General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery

Sanford Health33,000 enrolled

Overview

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. 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).

Study Type

OBSERVATIONAL

Enrollment

33,000

Conditions

Type 1 Diabetes Celiac Disease

Interventions

Sera and whole blood samplingDIAGNOSTIC_TEST

* 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)DIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 0 MinutesMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Sanford Bemidji Region Clinics

Bemidji, Minnesota, United States

RECRUITING

Sanford Bismarck Region Clinics

Bismarck, North Dakota, United States

RECRUITING

Sanford Fargo Region Clinics

Fargo, North Dakota, United States

RECRUITING

Outcomes

Primary Outcomes

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. 2. Of those who consented to be in the study, the percentage who went on to obtain the initial sample. 3. Of the total samples collected, percentage that were valid and results received. 4. The percentage of subjects who complete their \~60 month visit by their 6th birthday.

Time frame: By year 10 of the study