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Bediaga, N.G.* ; Li-Wai-Suen, C.S.N.* ; Haller, M.J.* ; Gitelman, S.E.* ; Evans-Molina, C.* ; Gottlieb, P.A.* ; Hippich, M. ; Ziegler, A.-G. ; Lernmark, A.* ; Dimeglio, L.A.* ; Wherrett, D.K.* ; Colman, P.G.* ; Harrison, L.C.* ; Wentworth, J.M.*

Simplifying prediction of disease progression in pre-symptomatic type 1 diabetes using a single blood sample.

Diabetologia, DOI: 10.1007/s00125-021-05523-2 (2021)

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AIMS/HYPOTHESIS: Accurate prediction of disease progression in individuals with pre-symptomatic type 1 diabetes has potential to prevent ketoacidosis and accelerate development of disease-modifying therapies. Current tools for predicting risk require multiple blood samples taken during an OGTT. Our aim was to develop and validate a simpler tool based on a single blood draw. METHODS: Models to predict disease progression using a single OGTT time point (0, 30, 60, 90 or 120 min) were developed using TrialNet data collected from relatives with type 1 diabetes and validated in independent populations at high genetic risk of type 1 diabetes (TrialNet, Diabetes Prevention Trial-Type 1, The Environmental Determinants of Diabetes in the Young [1]) and in a general population of Bavarian children who participated in Fr1da. RESULTS: Cox proportional hazards models combining plasma glucose, C-peptide, sex, age, BMI, HbA_1c and insulinoma antigen-2 autoantibody status predicted disease progression in all populations. In TrialNet, the AUC for receiver operating characteristic curves for models named M₆₀, M₉₀ and M₁₂₀, based on sampling at 60, 90 and 120 min, was 0.760, 0.761 and 0.745, respectively. These were not significantly different from the AUC of 0.760 for the gold standard Diabetes Prevention Trial Risk Score, which requires five OGTT blood samples. In TEDDY, where only 120 min blood sampling had been performed, the M₁₂₀ AUC was 0.865. In Fr1da, the M₁₂₀ AUC of 0.742 was significantly greater than the M₆₀ AUC of 0.615. CONCLUSIONS/INTERPRETATION: Prediction models based on a single OGTT blood draw accurately predict disease progression from stage 1 or 2 to stage 3 type 1 diabetes. The operational simplicity of M₁₂₀, its validity across different at-risk populations and the requirement for 120 min sampling to stage type 1 diabetes suggest M₁₂₀ could be readily applied to decrease the cost and complexity of risk stratification.

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Publication type Article: Journal article

Document type Scientific Article

Corresponding Author

Keywords Disease Progression ; Ogtt ; Prediction ; Prevention ; Risk Stratification ; Type 1 Diabetes; 1 Risk Score; Islet Autoantibodies; Ketoacidosis; Population; Relatives; Children; Teddy

ISSN (print) / ISBN 0012-186X

e-ISSN 1432-0428

Journal Diabetologia

Publisher Springer

Publishing Place Berlin ; Heidelberg [u.a.]

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Institute of Diabetes Research Type 1 (IDF)

Grants LifeScience-Stiftung
Leona M. and Harry B. Helmsley Charitable Trust
NIDDK NIH HHS