The Screening Process
A blood spot for a SNP-based genetic risk score is taken at study entry, which can be collected as early as the usual newborn screening samples. Autoantibodies for T1D are collected at approximately age 2 and 5 years of age at well child clinic appointments. At the latter screening, antibodies relevant to celiac disease will also be collected. This addition has been shown to increase family engagement and participation in other T1D screening programs. Children identified to have T1D autoantibodies will be offered ongoing monitoring and enrollment in appropriate intervention trials.
Critical to the success of this project is the innovative use of the electronic medical 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.
Timeline of PLEDGE Study Clinic Visits
0-60 Days Old
Genetic risk score for type 1 diabetes and celiac disease
2 Years Old
24-Month Well-Child Visit
Type 1 diabetes autoantibodies
4-6 Years Old
Pre-K Well-Child Visit
Type 1 diabetes and celiac disease autoantibodies
As part of this project, Sanford Research’s population health group will develop a dynamic economic model to assess costs and savings related to this screening approach. We will then 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, MD.