Evaluating the impact of severe hypoglycaemia definition wording on severe hypoglycaemia history assessment

Diabet Med. 2025 Jan 11:e15513. doi: 10.1111/dme.15513. Online ahead of print.

Abstract

Aim: Several wordings of the definition of severe hypoglycaemia (SH) exist. This study aims to evaluate how different SH definition wordings affect SH history assessment.

Methods: In this cross-sectional study, surveys were emailed to registrants of the T1D Exchange, a U.S. national type 1 diabetes patient registry. Participants' demographic information was collected. Six-month SH history was evaluated with questionnaires including SH definition wordings from either (1) professional societies, (2) a diabetes community website, or (3) a hypoglycaemia research questionnaire. Analyses included the McNemar test, pairwise Wilcoxon signed-rank test, logistic regression analysis, Kappa statistics, and Spearman correlation.

Results: A total of 1580 valid responses were obtained from participants (52% female; mean ± SD age: 46 ± 15 years; 95% White; mean ± SD diabetes duration: 25 ± 16 years). Questionnaires with four different SH definition wordings yielded significant variations in the prevalence of SH (i.e., having developed at least one episode of SH) and the number of SH episodes: the ADA/ENDO 2013 definition wording yielded the highest results on both metrics, whereas HypoA-Q and ADA 2023 yielded the lowest. Among participants reporting at least one SH episode, the number of episodes identified with the different SH definition wordings was poorly correlated (Rs: 0.09-0.37; p < 0.001). Race, education level, and household income were associated with higher odds of discrepancies in SH history (p < 0.05).

Conclusion: This U.S. national survey with individuals living with type 1 diabetes demonstrated significant discrepancies in SH history when assessed with different SH definition wordings. Race and socioeconomic status were associated with these discrepancies.

Keywords: clinical trial; epidemiological studies; hypoglycaemia; type 1 diabetes mellitus.