No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
0 Minutes – 17
Sex
Any
Study type
Observational
Participants needed
33,000 (estimated)
Sponsor
Sanford Health · Other
Who this trial is looking for
This trial is looking for children to participate in a screening for Type 1 Diabetes and celiac disease. Participants will be screened during their routine health care visits at a Sanford facility.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetes
You may be able to join if
I am a newborn infant born at a Sanford Health Hospital
I am a child under 6 years old receiving care at a Sanford facility
I am a child between 9 and 16 years old receiving care at a Sanford facility
I am a sibling of a child known to have T1D-relevant antibodies aged 6 to 17
I have an active MyChart account with proxy access
You may not be able to join if
I am unable to comply with the study requirements
I have been diagnosed with Type 1 diabetes
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Facility
City
State
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Status
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 Ho…
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
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