Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study

Abstract

<b><i>Background:</i></b> The GoBolus study investigated the real-world effectiveness of faster aspart in patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems. <b><i>Methods:</i></b> This 24-week, multicenter, single-arm, noninterventional study investigated adults with T1D (HbA_1c, 7.5%-9.5%) receiving multiple daily injections (MDI) of insulin and using iscCGM within local healthcare settings for ≥6 months before switching to faster aspart at study start (week 0; baseline). Primary endpoint was HbA_1c change from baseline to week 24. Exploratory endpoint was change in iscCGM metrics from baseline to week 24. <b><i>Results:</i></b> Overall, 243 patients were included (55.6% male), with mean age/diabetes duration, 49.9/18.8 years; mean HbA_1c, 8.1%. By week 24, HbA_1c had decreased by 0.19% (-2.1 mmol/mol, <i>P</i> < 0.0001) with no mean change in insulin doses or basal/bolus insulin ratios. For patients with sufficient available iscCGM data (<i>n</i> = 92): "time in range" (TIR; 3.9-10.0 mmol/L) increased from 46.9% to 50.1% (<i>P</i> = 0.01), corresponding to an increase of 46.1 min/day; time in hyperglycemia decreased from 49.1% to 46.1% (>10.0 mmol/L, <i>P</i> = 0.026) and 20.4% to 17.9% (>13.9 mmol/L, <i>P</i> = 0.013), corresponding to 43.5 (<i>P</i> = 0.024) and 35.6 (<i>P</i> = 0.015) fewer minutes per day on average spent in these ranges, respectively; no change for time in hypoglycemia (<3.9 and <3.0 mmol/L). Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (<i>P</i> = 0.035) and 11.9 to 11.0 mmol/L (<i>P</i> = 0.002), respectively. <b><i>Conclusion:</i></b> Real-world switching to faster aspart in adults with T1D on MDI improved HbA_1c, increased TIR, and decreased time in hyperglycemia without affecting time in hypoglycemia. The GoBolus study: NCT03450863.