The Screening Process
A blood spot for a SNP-based genetic risk score (GRS) is taken at study entry. For children enrolled prenatally, the GRS can be collected simultaneously with routine newborn screening samples. Autoantibodies for T1D are collected at routine clinic appointments at approximately between 2 and 5 years of age, or once between 9 and 16 years of age. At the latter screenings, celiac antibodies are also collected, the inclusion of which has shown increased family engagement in other T1D screening programs. Children identified to have T1D autoantibodies will be offered ongoing education, monitoring, and enrollment in appropriate intervention trials.
Critical to the success of this project is the innovative use of the electronic health record and associated patient messaging tools. Sanford Health has leveraged these platforms to automate invitations to participate, enable documentation of consent, collect assessments of parental worry, enter orders, and return results. Children with presymptomatic type 1 diabetes (multiple autoantibodies) are flagged for easy recognition to encourage appropriate testing in case they present for care with T1D symptoms.
As part of this project, economic modeling will be performed to assess costs and savings related to this screening approach. We will use real-world data from our health system and insurance plan to determine economic impacts.
This project is generously supported by Sanford Health and the Leona M. and Harry B. Helmsley Charitable Trust, with screening assays performed in collaboration with William Hagopian, MD, PhD, from the Pacific Northwest Research Institute and Richard Oram, PhD, from the University of Exeter and the Royal Devon and Exeter Hospital.
For research-related questions about the Sanford PLEDGE study, email Kurt Griffin, PhD, MD.