Beyond Glycaemia: Fear of Hypoglycaemia, Cognition and Functional Mobility After Advanced Hybrid Closed‐Loop Therapy in Older Adults With Type 1 Diabetes: A Prespecified Secondary Analysis of a Randomised, Single‐Centre Study
Authors' conclusion
In this small, selected cohort, AHCL therapy was associated with a nominally lower fear-of-hypoglycaemia score and better performance on selected mobility-related tests over 12 months. The fear-of-hypoglycaemia finding did not remain statistically significant after correction for multiple comparisons or additional adjustment for sex. Six-minute walk distance and Timed Up and Go remained statistically significant in the exploratory sex-adjusted sensitivity analyses, whereas the gait-speed difference did not. No measurable between-group deterioration in global cognition or processing speed was observed.
Study context
- Population
- Adults aged ≥ 65 years with long-standing T1D29 completed
- Participants
- 31 adults
- Comparison
- Advanced hybrid closed-loop (AHCL) therapy vs standard diabetes treatment
- Primary endpoint
- HFS-II score (baseline-adjusted primary analysis)
- Follow-up
- 12 months
Methodological detailsexploratory, single-centre, open-label, parallel-group, No formal sample-size calculation for these secondary outcomes
- Exploratory
- Single-centre
- Open-label
- Parallel-group
- No formal sample-size calculation for these secondary outcomes
Primary result
As reported in the abstract
Secondary outcomes
HFS-II score, exploratory model additionally adjusted for sex · 12 months
- Exploratory
6-min walk distance, sex-adjusted sensitivity analysis · 12 months
- Between-group difference in 6-min walk distance remained statistically significant
- 92.6 m (95% CI: 36.8 to 148.3; p = 0.002)
- Sex-adjusted sensitivity analysis
Timed Up and Go performance, sex-adjusted sensitivity analysis · 12 months
- Between-group difference in Timed Up and Go remained statistically significant
- −2.27 s (95% CI: −4.28 to −0.27; p = 0.028)
- Sex-adjusted sensitivity analysis
Gait speed, sex-adjusted sensitivity analysis · 12 months
- Between-group difference in gait speed not statistically significant
- 0.27 m/s (95% CI: −0.05 to 0.59; p = 0.099)
- Sex-adjusted sensitivity analysis
Diabetes distress, psychological well-being, global cognition and processing speed · 12 months
- Did not differ between groups
Fried frailty phenotype · 12 months
- AHCL: robust
- 12 of 14
- AHCL: pre-frail
- 2
- Control: robust
- 11 of 15
- Control: pre-frail
- 4
- Frail at follow-up
- 0
Original publication
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