Adherence to app‐based dose guidance for once‐weekly insulin icodec in insulin‐naive individuals with type 2 diabetes: Post hoc analysis of ONWARDS 5
Authors' conclusion
Greater adherence to app-based dose guidance was associated with greater estimated improvements in pre-breakfast SMBG and higher weekly insulin dose. Trends indicated HbA1c improvements in all adherence subgroups. Findings support app use for real-world insulin titration.
Study context
- Population
- Insulin-naive T2D participants randomized to once-weekly insulin icodec with a dosing guide app to assist titration in ONWARDS 5541 with app data
- Participants
- 542 participants
- Comparison
- 'Medium' and 'high' vs 'low' adherence to app-based dose guidance
- Lown = 52reference
- Mediumn = 215
- Highn = 239
Methodological detailsphase 3a, 52-week
- Phase 3a
- 52-week
Primary result
As reported in the abstract
Estimated mean pre-breakfast self-measured blood glucose (SMBG) and estimated mean weekly insulin dose · 52 weeks of app use
- Medium vs Low: P < 0.0001
- High vs Low: P < 0.0001
- Modelling analyses
Further findings
Administered icodec doses differing from app guidance (changed by participant)
- Doses differing from app guidance
- 1053/21 244; 5.0%
Health care professional overrides of app guidance
- Participants with ≥1 override (of 541 with app data)
- 56.7%
- Overrides that were increases to app-recommended dose
- 81.9%
Observed mean HbA1c · baseline to week 52
- Observed mean HbA1c decreased from baseline across all adherence subgroups
Safety
- Clinically significant hypoglycaemia rates were low across adherence subgroups
- No severe hypoglycaemia observed
Original publication
Adherence to app‐based dose guidance for once‐weekly insulin icodec in insulin‐naive individuals with type 2 diabetes: Post hoc analysis of ONWARDS 5. Diabetes Obes Metab. Published 13 August 2025. doi:10.
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