Glycemic and safety outcomes of the insulin-only bionic pancreas in older adults and individuals with impaired awareness of Hypoglycemia: a post hoc analysis of a randomized pivotal trial
Authors' conclusion
In high-risk, clinically vulnerable populations, the BP system significantly improved glycemic control while maintaining safety parity with respect to hypoglycemia risk
Study context
- Population
- People with T1D aged ≥60 years and/or with impaired awareness of hypoglycemia (Clarke score ≥4)of 440 in trial
- Participants
- 96 people
- Comparison
- Bionic pancreas vs standard care
- BP-Asp/Lisn = 45
- BP-Fiaspn = 31
- Standard care (SC)n = 20reference
Methodological detailsrandomised, individual participant-level data
- Randomised
- Individual participant-level data
Primary result
As reported in the abstract
TIR (70-180 mg/dL) · 13 weeks
Each group vs SCDifference, % (95 % CI)
BP-Asp/Lis∼1.8 h/day
7.49(2.61–12.38)
BP-Fiasp∼2.0 h/day
8.28(3.15–13.41)
Safety
| Outcome | BP-Asp/Lis | BP-Fiasp | SC |
|---|---|---|---|
| Severe hypoglycemiaEvents = participants; measures = number of events | |||
| Events | 4 | — not stated in the abstract | 2 |
| DKADue to an infusion set failure | — not stated in the abstract | 1 events | — not stated in the abstract |
— not stated in the abstract
Hypoglycemia exposure
- No significant differences in hypoglycemia exposure
Original publication
Glycemic and safety outcomes of the insulin-only bionic pancreas in older adults and individuals with impaired awareness of Hypoglycemia: a post hoc analysis of a randomized pivotal trial. Diabetes Res Clin Pract. Published 30 August 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →