PLEDGE (Sanford general-population screening)
Sanford Health / Sanford Research (funded by the Leona M. and Harry B. Helmsley Charitable Trust)
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.
The scorecard
Combines a SNP-based genetic risk score with islet-autoantibody testing; two or more persistent islet autoantibodies confer near-lifetime certainty of progression to clinical T1D, the validated staging basis PLEDGE is built on.[3]
Positive children enter close monitoring and education and can be routed to TrialNet/prevention trials; 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; over 15,000 children enrolled, but confined to Sanford's US footprint rather than nationwide.[2]
A small blood sample is taken alongside other routine draws (and a genetic-risk dried blood spot at entry); only the small autoantibody-positive minority need confirmatory follow-up testing.[2]
Open and free 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 SNP-based genetic risk score; islet autoantibodies are then measured at routine clinic appointments around ages 2 and 5, or once between ages 9 and 16, with celiac antibodies checked alongside. Children who carry two or more persistent islet autoantibodies are nearly certain to develop clinical T1D over time, 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 can largely prevent. Early identification also opens access to monitoring, symptom education, and prevention trials. PLEDGE has enrolled well over 15,000 children. 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) · registry · 2020-01-01
- [2]PLEDGE Pediatric Screening Study · manufacturer
- [3]Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective · peer-reviewed · 2022-01-01