Introduction and Objective: Personalized, HLA haplotype dependent, antigen specific therapy with GAD65 may preserve C-peptide in new-onset type 1 diabetes (T1D). Implementation of this individualized therapy necessitates targeted screening which may vary across regions. Methods: We analyzed data from the DIAGNODE-3 trial (NCT05018585) to evaluate the demographic distributions based on HLA DR3-DQ2 haplotype presence and region of screening (14 sites in United States US vs 47 sites in Europe EU). We hypothesized that demographic data may be different between regions. Statistical analyses used independent samples t-test and χ2 test. Results: The 778 participants were 18.9 ± 5.1 years at screening (enrollment ages 12-28 years old), 42.4% were Female, 96.0% were White, 218 (28.0%) had a family history of T1D, and 33.9% presented in DKA. Overall, 403 (51.8%) had HLA DR3-DQ2 (63 44.4% in the US vs 340 53.5% in EU, p=0.052). There were no demographic differences between those with or without the DR3-DQ2 haplotype. Participants screened in the US (n=142) versus the EU (n=636) were younger at T1D onset (17.8 ± 4.9 vs 19.1 ± 5.1 years, p=0.005), more likely to be female (52.8% vs 40.1%, p=0.006) and less likely to be White (89.4% vs 97.5%, p0.001). More US participants had a family history of T1D (41.5% vs 25.0%, p0.001) and presented in DKA (44.4% vs 31.6%, p=0.004). Technology use was different with a higher percentage of US participants using CGM (94.4% vs 85.7% in EU, p=0.005). Insulin administration mode differed (p0.001) with lower use of MDI in the US (70% vs 85%), higher use of semi/closed loop (14.8% vs 4.4%) and CSII pump (11.3% vs 6.4% in EU). Conclusion: In a new onset T1D personalized intervention study, screening demographics were different between US and EU populations. The US population was more racially diverse, with slightly lower HLA DR3-DQ2 frequency and more often utilized advanced diabetes management technologies. These differences may have practical implications for the implementation of this precision medicine approach across regions. Disclosure T.M. Triolo: None. D. Ahn: Speaker's Bureau; Current; Abbott, Ascensia Diabetes Care, MannKind Corporation, Insulet Corporation, Lilly, Novo Nordisk, Xeris Pharmaceuticals, Inc., Sequel Medtech, Dexcom, Inc. Advisory Panel; Ended; Lilly, MannKind Corporation. M. Martinez-Brocca: Advisory Panel; Ended; Sanofi. L. Nattero Chávez: None. T.W. Donner: Research Support; Current; Vertex Pharmaceuticals Incorporated. E. Franek: Speaker's Bureau; Current; AstraZeneca, BIOTON S.A., Boehringer Ingelheim International GmbH. Advisory Panel; Ended; Boehringer Ingelheim International GmbH. Speaker's Bureau; Current; Eli Lilly and Company. Advisory Panel; Ended; Novo Nordisk. Speaker's Bureau; Current; Novo Nordisk, KRKA, Sanofi, Zentiva Group, a.s. J. Gaglia: Consultant; Current; Vertex Pharmaceuticals Incorporated, AstraZeneca, polTreg. Research Support; Current; Sanofi. Stock/Shareholder; Current; Vertex Pharmaceuticals Incorporated. M. Gallagher: Research Support; Current; BioMarin Pharmaceutical Inc., T1D Exchange, IQVIA Inc., MannKind Corporation, National Institute of Diabetes and Digestive and Kidney Diseases, Sanofi-Aventis U.S., Diamyd. R. Cardona-Hernandez: Speaker's Bureau; Ended; Abbott Diabetes. Advisory Panel; Ended; Medtronic. Speaker's Bureau; Ended; Medtronic. Advisory Panel; Ended; Sanofi. Speaker's Bureau; Ended; Sanofi. T. Klupa: Speaker's Bureau; Current; Abbott Diabetes, Eli Lilly and Company, Boehringer Ingelheim International GmbH, Dexcom, Inc., Novo Nordisk. Research Support; Current; Medtronic. Advisory Panel; Current; Sanofi. Speaker's Bureau; Current; KRKA, Servier Laboratories, AstraZeneca. V. Neuman: None. M. Nieuwdorp: None. P. Teixeira: Employee; Current; Diamyd Medical. J. Ludvigsson: Research Support; Current; Diamyd Medical. Consultant; Current; Diamyd Medical. Funding DIAGNODE-3 trial is sponsored by Diamyd Medical
Triolo et al. (Fri,) studied this question.