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primary studies published RCT

Postprandial ultra-fast insulin versus mealtime fast-acting insulin in adults with cystic fibrosis-related diabetes: A randomized multicentre crossover trial.

  • Year: 2026
  • Date:
  • Author: Rakotoarisoa L
Source

Diabetes Res Clin Pract. 2026 Sep 1:113544. doi: 10.1016/j.diabres.2026.113544.

Study design (if review, criteria of inclusion for studies)

Open-label, multicentre, randomized phase IV crossover trial with a two-sequence, four-period design.

Participants

38 Adults with cystic fibrosis-related diabetes (CFRD); mean age: 33 ± 11 years; 56% receiving CFTR modulators

Interventions

Postprandial administration of ultra-fast-acting insulin (PP-UFI)vs standard mealtime fast-acting insulin (MT-FI).

Outcome measures

Glycaemic control. The primary endpoint was time in range (TIR: 70-180 mg/dL).

Main results

Baseline TIR was 74% [68-83], time below range (<70 mg/dL) was 4.1% [1.9-6.7], and ppFEV1 was 71 ± 25%. The estimated difference 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 observed. Formal equivalence was not demonstrated. Other CGM metrics, HbA1c, and insulin doses were comparable between treatments.

Authors' conclusions

These findings support the potential of postprandial ultra-fast-acting insulin as a flexible treatment option for adults with CFRD.

Keywords: Diabetes Mellitus; Gastrointestinal Diseases; Hypoglycemic Agents; Insulin; Oral; Pancreatic Diseases; pharmacological_intervention;