Evaluation of protocol amendments to the Environmental Determinants of Islet Autoimmunity (ENDIA) study during the COVID‐19 pandemic

Penno, Megan A. S.; Anderson, Amanda J.; Thomson, Rebecca L.; McGorm, Kelly; Barry, Simon C.; Colman, Peter G.; Craig, Maria E.; Davis, Elizabeth A.; Harris, Mark; Haynes, Aveni; Morahan, Grant; Oakey, Helena; Rawlinson, William D.; Sinnott, Richard O.; Soldatos, Georgia; Vuillermin, Peter J.; Wentworth, John M.; Harrison, Leonard C.; Couper, Jennifer J.

The Environmental Determinants of Islet Autoimmunity (ENDIA) Study is an Australia-wide observational pregnancy-birth cohort of children at genetic risk on account of a first-degree relative with type 1 diabetes (1). 1511 participants were recruited from all Australian States and Territories from 2013-2019 with 1473 live-born infants in follow-up. The standard protocol involves 3-monthly face-to-face visits from pregnancy until the child is 2 years of age, then 6-monthly visits. Study staff across nine centres in five States collect biospecimens (blood, urine, stool, swabs) and administer lifestyle and dietary questionnaires. Approximately 10% of the cohort are engaged in a Regional Participant Program (2) that requires self-collection of sample types except for venepuncture performed at local pathology services.