PLEDGE (Sanford general-population screening)
Sanford Health / Sanford Research (funded by the Leona M. and Harry B. Helmsley Charitable Trust)
What it is
A large US screening program from Sanford Health that tests children for the early immune markers of Type 1 diabetes (and celiac disease) during routine pediatric care, with the aim of catching the disease years before symptoms and avoiding crisis at diagnosis.
Editorial review: .
Most recent recorded citation date: 2022-01-01. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.
- Benefit or performance
- Predictive value: Combines a genetic risk assessment with islet-autoantibody testing; two or more persistent islet autoantibodies define presymptomatic stage 1 T1D, the validated staging basis PLEDGE is built on.[3]
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 85 × 25 + 80 × 25 + 70 × 20 + 78 × 15 + 60 × 15 = 7595; divide by total weight 100. Unrounded weighted result: 75.95.
Combines a genetic risk assessment with islet-autoantibody testing; two or more persistent islet autoantibodies define presymptomatic stage 1 T1D, the validated staging basis PLEDGE is built on.[3]
Positive children enter close monitoring and can be routed to further T1D monitoring or prevention studies; Sanford reports over 50% of its T1D diagnoses currently occur only after DKA, the crisis early detection is designed to prevent.[2]
Explicitly general-population (not relatives-only) and embedded in routine well-child visits across a large rural health system; more than 13,000 children enrolled, but confined to Sanford's US footprint rather than nationwide.[2]
Screening centers on a small blood sample, with a genetic-risk assessment at entry; only the small autoantibody-positive minority need confirmatory follow-up testing.[2]
Open to eligible Sanford patients while the study runs, but it is a research/feasibility program rather than a funded standing service, and availability is limited to Sanford's catchment.[1]
The full picture
PLEDGE (Population Level Estimation of Type 1 Diabetes Risk Genes in Children) is a Sanford Health screening program, funded by the Helmsley Charitable Trust, that looks for Type 1 diabetes (T1D) years before symptoms by folding testing into ordinary pediatric care rather than asking families to attend a separate research visit. It is a front door to early detection, not a treatment.
The program uses a two-step approach. At study entry a small blood sample provides a genetic risk assessment; islet autoantibodies are then measured at routine clinic appointments for children younger than 6 or between ages 9 and 16, with celiac antibodies checked alongside. Children who carry two or more persistent islet autoantibodies meet the definition of presymptomatic stage 1 T1D, the staging basis the screen relies on.
The payoff is avoiding crisis: Sanford reports that more than half of its T1D diagnoses still happen only after diabetic ketoacidosis, a dangerous and sometimes fatal presentation that close monitoring of screen-positive children is designed to help prevent. Early identification also opens access to monitoring and prevention trials. PLEDGE has enrolled more than 13,000 children and, on a 2026 registry check, is still recruiting toward a target of 33,000, with the study scheduled to run to 2031. Its main limit is reach: it is a feasibility program inside one health system, not yet a funded national service.
What's next for this
- →Continued reporting of autoantibody-positive yield, DKA-at-onset rates, and progression among screen-detected children to inform a scalable US screening model
Sources
- [1]General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery (PLEDGE) · Trial registry · 2020-01-01 — Live-checked 27 August 2026 — still recruiting, unchanged since its 2 March 2026 registry update. Observational, target enrolment 33,000, primary completion estimated March 2031; no results posted.
- [2]PLEDGE Pediatric Screening Study · Manufacturer
- [3]Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective · Peer-reviewed study · 2022-01-01