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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Minutes to 17 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The Sanford PLEDGE Study looks at whether screening children for signs of type 1 diabetes and celiac disease can fit into routine health visits. It checks for antibodies, which are immune system proteins linked to these diseases. The study is for children in certain age groups who get care at Sanford.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Newborn group: Babies born alive at 36 weeks of pregnancy, based on dates or ultrasound. They must be born at a Sanford Health Hospital and have plans for regular checkups at a Sanford Clinic.
  • For the newborn group, the mother must be at least 18 and willing and able to give informed consent (permission after learning about the study) before active labor starts.
  • Young child group: Children under age 6 who get routine care at Sanford and whose parents can give informed consent.
  • Older child group: Children ages 9–16 who get routine care at Sanford and whose parents can give informed consent.
  • Sibling group: Children ages 6–17 who get care at a Sanford clinic and have a sibling known to have antibodies linked to type 1 diabetes.
  • An active MyChart account with proxy access, which lets another person access the account.

Who can't join

  • Children the study doctor believes cannot follow the study requirements.
  • Children already known to have type 1 diabetes.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (4)

MN

ND

SD