Postprandial ultra-fast insulin versus mealtime fast-acting insulin in adults with cystic fibrosis-related diabetes: A randomized multicentre crossover trial.
Luc Rakotoarisoa, Pauline Mulette, Raphael Chiron et al.
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In 30 seconds
This open-label, multicentre, randomized phase IV crossover trial compared postprandial ultra-fast-acting insulin (PP-UFI) with standard mealtime fast-acting insulin (MT-FI) in adults with cystic fibrosis-related diabetes. Thirty-eight participants were enrolled, and 34 were included in the intention-to-treat analysis. Over 3-month treatment periods, the estimated difference in time in range between MT-FI and PP-UFI was +1.1 percentage points (95% CI: -1.1 to +3.3; p = 0.316), with no statistically significant difference. Formal equivalence was not demonstrated; other glucose metrics, HbA1c, and insulin doses were comparable.
Key findings
- The estimated MT-FI versus PP-UFI difference in time in range was +1.1 percentage points (95% CI: -1.1 to +3.3; p = 0.316).
- Formal equivalence between the insulin regimens was not demonstrated.
- Other CGM metrics, HbA1c, and insulin doses were comparable between treatments.
Why it matters
Post-meal insulin administration may offer flexibility for adults with CFRD, while this trial found no statistically significant difference in time in range compared with mealtime insulin. However, the absence of a significant difference does not establish equivalence. The findings help frame PP-UFI as a potential option while underscoring the limits of the evidence for assuming interchangeable glycaemic control.
What to keep in mind
The trial was open-label, and formal equivalence was not demonstrated.