Severe hypoglycemia (SH) is an acute complication of diabetes with potentially adverse clinical and psychosocial consequences. There is little published literature in terms of SH-related adverse events (AEs) in patients with type 1 diabetes (PwT1D) in a real-world setting. We recruited PwT1D who had recently started using the Tandem t:slim X2 insulin pump with Basal-IQ Predictive Low Glucose Suspend (PLGS). Amongst other measures, PwT1D reported SH-related AEs at baseline and then again at 6 months post-assessment (PA). Pre-Post differences were analyzed using Fisher’s exact test. In all, 665 PwT1D were included in the analysis (19% of these were <18 years old, mean age=37.11 years, female=55.5%, mean HbA1c=7.2%). Overall, 14.9% used multiple daily injections (MDIs) while 85.2% used insulin pumps as baseline therapy method. Nearly 91% of the sample reported using CGM at baseline. At PA, number of participants who reported to have 1 or more paramedic visits due to SH had significantly decreased from 35 to 19 (p<0.001), emergency room (ER) visits dropped to 9 (vs. 39 at baseline, p<0.001), and hospital admissions were reduced to 6 (vs. 24 at baseline, p<0.05) for the entire sample. These differences were observed irrespective of the baseline therapy method (MDIs vs. pump users) although the largest differences were noticed for MDIs (reduction of -9.47% (paramedic visits), -10.53% (ER visits), and -8.42% (hospital admissions). Risk-ratio assessment for AEs overall, per 100 person years showed a drop at PA for all 3 AE categories (paramedic visits, 21.98 vs. 7.33; ER visits, 19.24 vs. 4.27; hospital admissions, 11.30 vs. 2.75). The Basal-IQ PLGS technology demonstrated remarkable reductions in self-reported SH-related AEs for both pediatric and adult PwT1D.
H. Singh: Employee; Self; Tandem Diabetes Care. M.L. Manning: Employee; Self; Tandem Diabetes Care. M. McElwee-Malloy: Employee; Self; Tandem Diabetes Care. S. Habif: Employee; Self; Tandem Diabetes Care.