This single-arm, observational, non-interventional study assessed the effectiveness and safety of fast-acting insulin aspart (Novo Nordisk’s Fiasp) in a real-world cohort of people with type 1 diabetes in Germany. A total of 241 adults with type 1 diabetes on multiple daily injections who switched their bolus insulin to fast aspart and who were established users of flash glucose monitoring were followed up at treatment initiation and 12 and 24 weeks thereafter.
Over the follow-up, mean HbA1c fell significantly, from 64.8 to 62.8 mmol/mol, while postprandial glucose levels fell by 0.8 mmol/L. Among the 92 participants who had sufficient glucose monitoring data, time in range increased from 46.9% to 50.1% at the final follow-up. This was driven by a reduction in time spent in hyperglycaemia, while hypoglycaemia rates were unchanged. Safety analysis of the whole cohort did not reveal any unexpected findings.
The authors conclude that these real-world results reflected the findings in the ONSET phase 3 clinical trials of fast-acting aspart, highlighting the improved glycaemic control via reduced hyperglycaemia, without any changes in basal insulin or mean insulin dose.
Danne T, Schweitzer MA, Keuthage W et al (2020) 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. Diabetes Technol Ther 21 Oct [epub ahead of print]. https://doi.org/10.1089/dia.2020.0360