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

NCT04477928 | Recruiting

• 1 other identifier: PLEDGE
• Study Type: observational
• Target: 33,000
• Locations: 1 country
• Sites: 4

Brief Summary

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

Celiac Disease; Type 1 Diabetes

Keywords

Population screening; Type 1 Diabetes; Celiac Disease; Autoantibodies; Prevention; Diabetic Ketoacidosis (DKA); Genetic Risk Score; Differential Gene Expression; Economic Modeling; Quality of Life; Feasibility; Pragmatic; T1D

Outcome Measures

Primary Outcomes (1)

• Demonstrated feasibility of large-scale population screening, as evidenced by:

  1. The percentage of parent(s) that viewed the MyChart study information who went on to complete the MyChart informed consent, HIPAA and questionnaires. 2. Of those who consented to be in the study, the percentage who went on to obtain the initial sample. 3. Of the total samples collected, percentage that were valid and results received. 4. The percentage of subjects who complete their \~60 month visit by their 6th birthday.

  By year 10 of the study

Secondary Outcomes (8)

• Seroconversion rates for T1D-relevant and celiac autoantibodies

  By year 10 of study

• Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.

  By year 10 of study

• Percentage of celiac seropositive subjects referred on to GI or primary care

  By year 10 of study

• The percentage of celiac seropositive subjects who were evaluated in clinical setting

  By year 10 of study

• The rate of development of overt hyperglycemia consistent with T1D (Stage 3).

  By year 10 of study

Study Arms (1)

Study Group

Children receiving routine care at a Sanford facility

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

Interventions

Sera and whole blood sampling 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

Study Group

Differential Gene Expression (DGE) DIAGNOSTIC_TEST

Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age

Study Group

Eligibility Criteria

• Age: 0 Minutes - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children born at and/or followed at Sanford Health System facilities: 1. . 0-5 years of age; 2. . 9-16 years of age; 3. . Siblings of children known to have T1D-relevant antibodies, ages 6 to 17 years old.

You 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 may not qualify if:

• Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
• Children known to have T1D

Sponsors & Collaborators

• Sanford Health: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• Pacific Northwest Research Institute: collaborator
• University of Exeter: collaborator

Study Sites (4)

Sanford Bemidji Region Clinics

Bemidji, Minnesota, 56601, United States

RECRUITING

Sanford Bismarck Region Clinics

Bismarck, North Dakota, 58501, United States

RECRUITING

Sanford Fargo Region Clinics

Fargo, North Dakota, 58112, United States

RECRUITING

Sanford Sioux Falls Region Clinics

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Related Publications (1)

• Sims EK, Besser REJ, Dayan C, Geno Rasmussen C, Greenbaum C, Griffin KJ, Hagopian W, Knip M, Long AE, Martin F, Mathieu C, Rewers M, Steck AK, Wentworth JM, Rich SS, Kordonouri O, Ziegler AG, Herold KC; NIDDK Type 1 Diabetes TrialNet Study Group. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes. 2022 Apr 1;71(4):610-623. doi: 10.2337/dbi20-0054.

  PMID: 35316839 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Celiac Disease; Diabetic Ketoacidosis; Genetic Risk Score

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kurt Griffin, PhD, MD

  Sanford Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Mays, RN, CPN

CONTACT

605-312-6052; ann.mays@sanfordhealth.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 20, 2020
• Study Start: July 17, 2020
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Data will be available no later than 12 months after the conclusion of study.
• Access Criteria: Data available to researchers approved by investigators.

Locations

US (4)