General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sera and whole blood sampling, Differential Gene Expression (DGE).
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes, Celiac Disease. Basic parameters: 0 Minutes — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
Overview
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.
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).
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 * 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
Primary outcome measures
- Demonstrated feasibility of large-scale population screening, as evidenced by: [Time frame: By year 10 of the study]
Secondary outcome measures (8)
- Seroconversion rates for T1D-relevant and celiac autoantibodies [Time frame: 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]
- Percentage of celiac seropositive subjects referred on to GI or primary care [Time frame: By year 10 of study]
- The percentage of celiac seropositive subjects who were evaluated in clinical setting [Time frame: By year 10 of study]
- The rate of development of overt hyperglycemia consistent with T1D (Stage 3). [Time frame: 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]
- Number and type of procedure-related adverse events [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 4 centers
- Sanford Bemidji Region Clinics — Bemidji
- Sanford Bismarck Region Clinics — Bismarck
- Sanford Fargo Region Clinics — Fargo
- Sanford Sioux Falls Region Clinics — Sioux Falls
Publications
- 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
Identifiers
NCT: NCT04477928 · PLEDGE