Safety and Functionality of a Novel Clinical Decision-Support Algorithm with Insulin Efsitora Alfa in Adults with Type 2 Diabetes: Early Feasibility Study
Authors' conclusion
The novel CDS algorithm showed promising clinical performance and favorable investigator confidence as determined by a low rate of dose overrides.
Study context
- Population
- Adults with T2D with or without basal insulin, dosed with once-weekly insulin efsitora via a novel clinical decision-support (CDS) algorithm
- Participants
- 68 adults2 sequential cohorts
- Comparison
- Cohort 1 basal-switch vs Cohort 1 insulin-naïve vs Cohort 2 basal-switch vs Cohort 2 insulin-naïve
- Outcome
- CDS dose recommendation overrides (% of injections)
- Follow-up
- 16 weeks
Methodological details16-week, multicenter, open-label, two sequential cohorts, Investigators requested an efsitora dose from the CDS algorithm and either overrode or accepted the recommendation
- 16-week
- Multicenter
- Open-label
- Two sequential cohorts
- Investigators requested an efsitora dose from the CDS algorithm and either overrode or accepted the recommendation
Main finding
As reported in the abstract
CDS dosing recommendation overrides (% of injections)
Further findings
Baseline mean HbA1c
- Basal-switch participants, both cohorts: mean HbA1c range
- 7.9% to 8.5%
- Insulin-naïve participants: mean HbA1c range
- 8.1% to 8.3%
HbA1c change · baseline to Week 16
- HbA1c significantly reduced in both subgroups for both cohorts
- P < 0.05
Fasting blood glucose within targets · baseline to Week 16
- Proportion with fasting blood glucose within targets increased in both subgroups for both cohorts
Safety
- No level 3 hypoglycemia observed
Original publication
Safety and Functionality of a Novel Clinical Decision-Support Algorithm with Insulin Efsitora Alfa in Adults with Type 2 Diabetes: Early Feasibility Study. Diabetes Technol Ther. Published 12 May 2025. doi:10.
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