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

Background: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. Methods: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. Results: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,P < 0.0001) with no mean change in insulin doses or basal/bolus insulin ratios. For patients with sufficient available iscCGM data (n = 92): time in range (TIR; 3.9-10.0 mmol/L) increased from 46.9% to 50.1% (P = 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,P = 0.026) and 20.4% to 17.9% (>13.9 mmol/L,P = 0.013), corresponding to 43.5 (P = 0.024) and 35.6 (P = 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 (P = 0.035) and 11.9 to 11.0 mmol/L (P = 0.002), respectively. Conclusion: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.

Automated summary

The study showed that switching to faster aspart in adults with T1D on MDI improved HbA(1c), increased time in range, and decreased time in hyperglycemia, with no significant change in time spent in hypoglycemia.