Introduction & Objective: In ONWARDS 5, a 52-week, phase 3a trial, participants in the insulin icodec (icodec) group used a dosing guide app to assist titration. This post hoc analysis assessed adherence to app-based dose guidance and its association with prebreakfast self-measured blood glucose (SMBG).
Methods: The app provided weekly algorithm-driven icodec dose guidance based on prebreakfast SMBG. Regardless, investigators could suggest manual dose changes. Estimated mean prebreakfast SMBG over time was compared across app-based guidance adherence subgroups (Figure).
Results: On average 5.0% of administered icodec doses differed from app guidance (dose change by participant). Of 541 participants assessed, 56.7% had ≥1 manual dose change during the trial; most changes (82%) were increases to the dose recommended by the app. Estimated mean prebreakfast SMBG improved from baseline irrespective of adherence to app guidance. Medium/high adherence subgroups had statistically significantly lower mean prebreakfast SMBG (p<0.0001) with earlier achievement of target level (80-130 mg/dL) than the low adherence subgroup (Figure).
Conclusion: Most administered icodec doses were adherent with app guidance; medium/high vs low adherence to app guidance was associated with improved estimated SMBG. The findings support the use of dose guidance apps to assist real-world insulin titration.
H.S. Bajaj: Research Support; Abbott, Amgen Inc., Anji Pharmaceuticals, Boehringer-Ingelheim, Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc. A.M. Donatsky: Employee; Novo Nordisk A/S. S. Engberg: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. J.H.J. Martiny: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. A.G. Vianna: Board Member; Abbott, Lilly Diabetes, Novo Nordisk, Medtronic. Speaker's Bureau; AstraZeneca, Novo Nordisk. Research Support; Novo Nordisk, Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Research Support; Servier Laboratories. I. Lingvay: Consultant; Altimmune, Astra Zeneca, Bayer, Biomea, Boehringer-Ingelheim, Carmot, Cytoki Pharma, Eli Lilly, Intercept, Janssen/J&J, Mannkind, Mediflix, Merck, Metsera, Novo Nordisk, Pharmaventures, Pfizer, Sanofi. Research Support; NovoNordisk, Sanofi, Mylan, Boehringer-Ingelheim. Consultant; TERNS Pharma, The Comm Group, Valeritas, WebMD, and Zealand Pharma.
Novo Nordisk A/S