Guidance to Persons Who Screen Positive for Islet Autoantibodies and Their Health Care Providers-Ask the Experts

Objective: Detecting early-stage type 1 diabetes (T1D) by screening for islet autoantibodies (IA) can prevent serious morbidity at clinical onset and allow for a trial prevention, e.g., FDA-approved teplizumab therapy. The Ask the Experts program provides confirmation of positive screening results, monitoring, and education for individuals who screen positive for IA as well as their families and health care providers (HCPs). Methods: Individuals and HCPs concerned for T1D (e.g., screen positive for IA) can enroll in Ask the Experts via phone, e-mail or website. We recommend and facilitate screening or confirmation of IA status and collect demographic and clinical data. When IA positivity is confirmed, we partner with HCPs to provide early T1D training and collaborative follow-up, customized to HCP interest and clinical capacity. Results: We have enrolled 71 participants to date, mostly youth (83%), aged 1 to 62 years (61% female; 79% non-Hispanic white). Most referrals were for confirmation of IA results (52%) or HCP concern for early T1D based on dysglycemic HbA1c or glucose (30%). IA were measured at 6 commercial laboratories, including the Barbara Davis Center Autoantibody Laboratory with 53% screening positive for a single IA and 47% for multiple IA. The most common IA detected was insulinoma antigen-2 IA (48%) with glutamic decarboxylase 65 and insulin IAs both present in 41% of those who screened positive. Of those who presented with one or more IA on screening, 66% were negative for all four major IA on confirmation testing completed at the Barbara Davis Center Autoantibody Laboratory. 80% of individuals confirmed IA positive have engaged in remote monitoring while 20% have been followed by their local HCP with our training and support. Conclusion: Persons who screen positive for IA should have confirmation testing completed given the discordance between screening and confirmation results. HCPs require support for following screening detected individuals. Disclosure K.M.Simmons: Advisory Panel; Provention Bio, Inc., Consultant; Dexcom, Inc., Provention Bio, Inc., Research Support; Novartis. K.A.Bautista: None. C.Geno rasmussen: None. R.Karban: None. H.K.O'donnell: None. B.I.Frohnert: Advisory Panel; Provention Bio, Inc. A.Steck: None. M.Rewers: Research Support; Provention Bio, Juvenile Diabetes Research Foundation (JDRF), Hemsley Charitable Trust, Dexcom, Inc., Janssen Research & Development, LLC. Funding The Leona M. and Harry B. Helmsley Charitable Trust