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

February 26, 2026 updated by: Sanford Health

Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often are not diagnosed until the child is very sick. Research suggests that screening and identifying children at risk for T1D autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes.

The investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (T1D), or referred to clinical care (celiac).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Recruiting
        • Sanford Bemidji Region Clinics
        • Contact:
        • Principal Investigator:
          • Kurt Griffin, PhD, MD
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Recruiting
        • Sanford Bismarck Region Clinics
        • Contact:
        • Principal Investigator:
          • Kurt Griffin, PhD, MD
      • Fargo, North Dakota, United States, 58112
        • Recruiting
        • Sanford Fargo Region Clinics
        • Principal Investigator:
          • Kurt Griffin, PhD, MD
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Sioux Falls Region Clinics
        • Principal Investigator:
          • Kurt Griffin, PhD, MD
        • Sub-Investigator:
          • 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
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Group
Children receiving routine care at a Sanford facility
Diagnostic test: Sera and whole blood sampling
  • 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
Diagnostic test: Differential Gene Expression (DGE)
Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demonstrated feasibility of large-scale population screening, as evidenced by:
Time Frame: By year 10 of the study
  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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Seroconversion rates for T1D-relevant and celiac autoantibodies
Time Frame: By year 10 of study
By year 10 of study
Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.
Time Frame: By year 10 of study
By year 10 of study
Percentage of celiac seropositive subjects referred on to GI or primary care
Time Frame: By year 10 of study
By year 10 of study
The percentage of celiac seropositive subjects who were evaluated in clinical setting
Time Frame: By year 10 of study
By year 10 of study
The rate of development of overt hyperglycemia consistent with T1D (Stage 3).
Time Frame: By year 10 of study
By year 10 of study
Proportion of participants developing overt hyperglycemia consistent with T1D (Stage 3), who present in diabetic ketoacidosis (DKA)
Time Frame: By year 10 of study
By year 10 of study
Number and type of procedure-related adverse events
Time Frame: By year 10 of study
By year 10 of study
Assessment of costs associated with implementation of study compared to potential impacts on cost and quality of life.
Time Frame: By year 10 of study
By year 10 of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanford Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Exeter
The Leona M. and Harry B. Helmsley Charitable Trust
Pacific Northwest Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kurt Griffin, PhD, MD, Sanford Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLEDGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified patient characteristics, clinical and laboratory outcomes will be shared in an online platform.

IPD Sharing Time Frame

Data will be available no later than 12 months after the conclusion of study.

IPD Sharing Access Criteria

Data available to researchers approved by investigators.

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on Sera and whole blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings