Trial reportDiabetes, obesity & metabolism2025
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.
Trial report in Diabetes, obesity & metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04760626 (Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting
Who cites it
2 citing papers in PubMed.
- 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, obesity & metabolism · 2025Trial
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
aimsIn ONWARDS 5 (NCT04760626), a 52-week, Phase 3a trial in insulin-naive type 2 diabetes, 542/1085 participants were randomized to once-weekly insulin icodec with a dosing guide app to assist titration (icodec with app). This post hoc analysis of the icodec with app group assessed titration behaviours and associations between app-based dose guidance adherence and outcomes. MATERIALS AND
methodsApp-based dose guidance and manual overrides were assessed. App guidance adherence was defined as dose guidance being requested and followed, and that automatic dose titration was possible; adherence subgroups were defined by mean fraction of weeks adherent across all weeks with app usage (per 4 weeks: 'low', ≤1 [n = 52]; 'medium', >1-≤3 [n = 215]; 'high', >3 [n = 239]). Observed glycated haemoglobin (HbA1c; baseline to week 52) and hypoglycaemia were described. Modelling analyses assessed associations between app adherence and estimated pre-breakfast self-measured blood glucose (SMBG) and weekly insulin dose.
resultsFew administered icodec doses (1053/21 244; 5.0%) differed from app guidance (dose changed by participant). Across 541 participants with app data, 56.7% had ≥1 app guidance override by a health care professional; most overrides (81.9%) were increases to app-recommended dose. Observed mean HbA1c decreased from baseline across all adherence subgroups. Across 52 weeks of app use, 'medium' and 'high' versus 'low' adherence was associated with significantly lower estimated mean pre-breakfast SMBG and higher estimated mean weekly insulin dose (both p < 0.0001). Clinically significant hypoglycaemia rates were low across subgroups, with no severe hypoglycaemia observed.
conclusionsGreater 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.