What this study is
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.
What's being tested
- Sera and whole blood sampling
Intervention · DIAGNOSTIC 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)
Intervention · DIAGNOSTIC TEST
Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age
Study details
- Official title
- Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
- Sponsor
- Sanford Health
- Conditions
- Type 1 Diabetes · Celiac Disease
- Enrolling
- 33,000 people
- Starts
- 2020-07-17
- Est. completion
- 2031-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Minutes – 17 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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).
You can't join if
- Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
- Children known to have T1D
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openContact for every open site
- Ann Mays, RN, CPN · Contact605-312-6052ann.mays@sanfordhealth.org
- Kurt Griffin, PhD, MD · Principal investigator
Sanford Bemidji Region Clinics
Bemidji, Minnesota, United States
RecruitingSanford Bismarck Region Clinics
Bismarck, North Dakota, United States
RecruitingSanford Fargo Region Clinics
Fargo, North Dakota, United States
RecruitingSanford Sioux Falls Region Clinics
Sioux Falls, South Dakota, United States
- Sharon Hunt, BS, MS, MBA · Sub-investigator
- Candice Nelson, MD, FAAP · Sub-investigator
- Stephanie Hanson, MD, FAAP · Sub-investigator
- Louis Casas, MD, FAAP · Sub-investigator
- Brenda Thurlow, MD, FAAP · Sub-investigator
- Kyle Baum, MD · Sub-investigator
- Ann Mays, RN, CPN · Sub-investigator
Recruiting
Study team
Sponsor
Sanford Health
Study ID PLEDGE
Principal investigator
Kurt Griffin, PhD, MD
Sanford Research
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.