Actively Recruiting

Age: 0Minutes - 17Years
All Genders
Healthy Volunteers
NCT04477928

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

Led by Sanford Health · Updated on 2026-03-02

33000

Participants Needed

4

Research Sites

554 weeks

Total Duration

On this page

Sponsors

S

Sanford Health

Lead Sponsor

T

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Minutes - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborns born at 36 weeks gestation or later at a Sanford Health Hospital to mothers aged 18 years or older who can provide informed consent before labor and plan to receive routine well-child care at a Sanford Clinic
  • Children under 6 years old receiving routine care at a Sanford facility with parents able to provide informed consent
  • Children aged 9 to 16 years receiving routine care at a Sanford facility with parents able to provide informed consent
  • Siblings aged 6 to 17 years of children known to have type 1 diabetes relevant antibodies who receive care at a Sanford clinic
  • Have an active MyChart account with proxy access
Not Eligible

You will not qualify if you...

  • Investigator believes the child cannot comply with study requirements
  • Children already diagnosed with type 1 diabetes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Sanford Bemidji Region Clinics

Bemidji, Minnesota, United States, 56601

Actively Recruiting

2

Sanford Bismarck Region Clinics

Bismarck, North Dakota, United States, 58501

Actively Recruiting

3

Sanford Fargo Region Clinics

Fargo, North Dakota, United States, 58112

Actively Recruiting

4

Sanford Sioux Falls Region Clinics

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

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Research Team

A

Ann Mays, RN, CPN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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