General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-17
SponsorSanford Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
Children known to have T1D
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
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
Differential Gene Expression (DGE)
Diagnostic testOpt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age
Treatment groups
33,000 Participants
are divided into 1 treatment groupGroup A: Study Group2 interventions
Trial outcomes
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.
Time frame
By year 10 of the studySecondary outcomes
1
Seroconversion rates for T1D-relevant and celiac autoantibodies
Time frame
By year 10 of study2
Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.
Time frame
By year 10 of study3
Percentage of celiac seropositive subjects referred on to GI or primary care
Time frame
By year 10 of study4
The percentage of celiac seropositive subjects who were evaluated in clinical setting
Time frame
By year 10 of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sanford Health
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
Pacific Northwest Research Institute
Collaborator
University of Exeter
Collaborator
Source ClinicalTrials.gov