Objectives: The goal was to implement a risk profile that would prospectively identify youth with T1D at risk of severe hypoglycemia (SH) over the course of 1 year. We hypothesized that subjects with specific risk factors such as prior SH, a high frequency of nocturnal hypoglycemia (NH), and impaired hypoglycemia awareness would have a high rate of SH within the following year. If confirmed, an accurate assessment can lead to efficient application of interventions to reduce future risk of SH.
Methods: 404 subjects were followed for 14 months for SH, defined as a seizure, coma or loss of consciousness in the setting of presumed hypoglycemia (ISPAD guidelines). Subjects completed a survey that queried about SH, NH, and hypoglycemia unawareness. Comparisons were made using Chi-squared or Fisher’s exact tests for categorical variables and Wilcoxon Rank-Sum tests for continuous variables.
Results: Of the 404 enrolled, 18 subjects had SH in 14 months (4.46%). In the univariate analysis, those who had SH had indicated SH on the enrollment questionnaire (p-value 0.0015) and hypoglycemia unawareness as always or often (p-value 0.0259). Subjects with SH were more likely to wear CGMs (p-value 0.0369). Subject characteristics, T1D management, insurance, and NH were not statistically significant. In addition, we evaluated the 13 subjects who indicated on their initial questionnaire SH in the prior three months. In the univariate analysis, those subjects had more NH defined as ≥2 nights in a 3 month period (P=0.006) and less hypoglycemia awareness (P=0.030). With regards to insulin management, they had a lower insulin sensitivity factor (P=0.012) and higher proportion of basal insulin (P=0.003).
Conclusions: In a diverse cohort of T1D, this study shows the ability to identify pediatric subjects at risk for SH with hypoglycemia unawareness and prior SH. As SH is a rare event, as this study is expanded, there is the opportunity for a scored risk questionnaire to capture T1D youth at risk for SH.
K. Cossen: None. J. Figueroa: None. A.B. Muir: None.