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

Sanford Health

Status: Enrolling

Conditions: Celiac Disease; Type 1 Diabetes

Treatments: Diagnostic Test: Sera and whole blood sampling; Diagnostic Test: Differential Gene Expression (DGE)

Study type: Observational

Funder types: Other

Identifiers

NCT04477928

PLEDGE

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 33,000 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

33,000 participants in 1 patient group

Study Group

Description:

Children receiving routine care at a Sanford facility

Treatment:

Diagnostic Test: Differential Gene Expression (DGE)

Diagnostic Test: Sera and whole blood sampling