The Estimation of the Prevalent Presymptomatic Type 1 Diabetes Population in Germany Using a Patient Funnel Model
Author(s)
Aymeric Mahieu, PharmD1, Omar Alsaleh Abdul Jabbar, PharmD, MHEcon2, Tom Clemmet, MSc3, Hasan Basarir, PhD3, Denis Azabdaftari, MSc4, Klaus Bornholdt, PhD4, Maja Hergl, BSc5, Anette G Ziegler, MD, PhD5.
1Sanofi, Paris, France, 2Sanofi, Milan, Italy, 3RTI Health Solutions, Manchester, United Kingdom, 4Sanofi, Berlin, Germany, 5Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany.
1Sanofi, Paris, France, 2Sanofi, Milan, Italy, 3RTI Health Solutions, Manchester, United Kingdom, 4Sanofi, Berlin, Germany, 5Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany.
OBJECTIVES: Type 1 diabetes (T1D) is generally diagnosed at the onset of clinical symptoms (stage 3). Recently, presymptomatic stages— single autoantibody, stage 1 (multiple autoantibodies, normoglycemia), and stage 2 (multiple autoantibodies, dysglycemia) — have gained recognition as part of the broader T1D continuum. However, evidence on presymptomatic T1D remains limited. Existing estimates on presymptomatic T1D progression often rely on data reported by specific screening programs that may be difficult to generalize to broader populations. This study introduces a novel approach that leverages incidence (stage 3) data to estimate the prevalence of presymptomatic T1D.
METHODS: A cohort-level model was developed to estimate the number of individuals in presymptomatic T1D stages in Germany. Age-specific incidence data for Stage 3 T1D (Reitzle et al., 2023) and median time from seroconversion to Stage 3 onset (Ghalwash et al., 2022) were used to estimate the population sizes in pediatrics and adults by presymptomatic stages at model initiation. Transition probabilities between presymptomatic stages were derived using Kaplan-Meier curves for stage-specific progression (Fr1da study data), adjusted by age (Wherrett et al., 2015). Parametric survival models were fitted to estimate long-term progression. The model was calibrated using national demographic data, including age distribution and birth trends.
RESULTS: Preliminary model results suggest approximately 710,876 individuals in Germany would be categorized as exhibiting a single autoantibody, 103,249 as Stage 1, and 66,395 as Stage 2 presymptomatic T1D in 2026. For those aged 8 and older, the corresponding estimates were 675,961, 90,609, and 64,067, respectively.
CONCLUSIONS: Using well-documented (stage 3) incidence rates and time to seroconversion, and extrapolating over 20 years using presymptomatic progression rates, a robust approach was developed to estimate the population size in presymptomatic T1D stages. These estimates may help inform the design of screening programs aimed at identifying individuals in presymptomatic stages and intervening to delay progression to stage 3 onset.
METHODS: A cohort-level model was developed to estimate the number of individuals in presymptomatic T1D stages in Germany. Age-specific incidence data for Stage 3 T1D (Reitzle et al., 2023) and median time from seroconversion to Stage 3 onset (Ghalwash et al., 2022) were used to estimate the population sizes in pediatrics and adults by presymptomatic stages at model initiation. Transition probabilities between presymptomatic stages were derived using Kaplan-Meier curves for stage-specific progression (Fr1da study data), adjusted by age (Wherrett et al., 2015). Parametric survival models were fitted to estimate long-term progression. The model was calibrated using national demographic data, including age distribution and birth trends.
RESULTS: Preliminary model results suggest approximately 710,876 individuals in Germany would be categorized as exhibiting a single autoantibody, 103,249 as Stage 1, and 66,395 as Stage 2 presymptomatic T1D in 2026. For those aged 8 and older, the corresponding estimates were 675,961, 90,609, and 64,067, respectively.
CONCLUSIONS: Using well-documented (stage 3) incidence rates and time to seroconversion, and extrapolating over 20 years using presymptomatic progression rates, a robust approach was developed to estimate the population size in presymptomatic T1D stages. These estimates may help inform the design of screening programs aimed at identifying individuals in presymptomatic stages and intervening to delay progression to stage 3 onset.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH234
Topic
Epidemiology & Public Health
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)