Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||N/A - 5 Years|
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Type 1 Diabetes, Celiac Disease|
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.
: Newborn/Delayed Entry Group
Children 0-5.99 years old
: DGE- Opt In Group
36 weeks gestation up until onset of active labor
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
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.