General Population Level Estimation for Type 1 Diabetes Risk in Children 0-5 Years Old During Routine Care Delivery

Study Purpose

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 for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5, years of age. Children found to have these markers will be either be referred to clinical care or offered participation in other monitoring or prevention trials.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 5 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Newborn Entry: Viable term infants, defined as 36 weeks gestation by either dates or ultrasound.
  • - Born to pregnant women, 18 years or older, who are willing and able to provide informed consent prior to the onset of active labor.
  • - Are born at a Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic.
  • - Delayed Entry: Children less than 6 years of age who receive their routine care at a Sanford Health facility and whose parents are able to provide informed consent.
  • - Use Sanford electronic patient portal.

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04477928
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sanford Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kurt Griffin, PhD, MD
Principal Investigator Affiliation Sanford Research
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Type 1 Diabetes, Celiac Disease
Additional Details

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.

Arms & Interventions

Arms

: Newborn/Delayed Entry Group

Children 0-5.99 years old

: DGE- Opt In Group

36 weeks gestation up until onset of active labor

Interventions

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, SARS-CoV-2 antibodies.

Diagnostic Test: - Differential Gene Expression (DGE)

Birth: SNP-Based Genetic Risk Score, Differential Gene Expression. 12 months old: Differential Gene Expression, T1D autoantibodies, SARS-CoV-2 antibodies. 2 years old: T1D autoantibodies, SARS-CoV-2 antibodies. 5 years old: T1D and celiac related autoantibodies, SARS-CoV-2 antibodies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sanford Clinic, Sioux Falls, South Dakota

Status

Recruiting

Address

Sanford Clinic

Sioux Falls, South Dakota, 57105

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