Real-World Evidence Analysis of a Hybrid Closed-Loop System
Authors' conclusion
Glycemic outcomes from the present real-world evidence are comparable to results obtained from previous randomized controlled studies and confirm the efficacy of this hybrid closed-loop system in real-world settings.
Study context
- Population
- Users of all age groups from 15 countries who used the mylife CamAPS FX HCL system between May 9, 2022, and December 3, 2022, with ≥30 days of CGM data and ≥30% closed-loop usage
- Participants
- 1,805 users
- Outcome
- TIR (3.9-10 mmol/L)
Methodological details15 countries, ≥30 days of CGM data and ≥30% closed-loop usage
- 15 countries
- ≥30 days of CGM data and ≥30% closed-loop usage
Main finding
As reported in the abstract
Mylife CamAPS FX
72.6
mean · SD 11.5 · %
- TIR, users ≤6 years old (mean ± SD)
- 66.9 ± 11.7%
- TIR, users ≥65 years (mean ± SD)
- 81.8 ± 8.7%
Further findings
Time in hypoglycaemia (<3.9 mmol/L)
- Time in hypoglycaemia (<3.9 mmol/L), median [IQR]
- 2.3% [1.3, 3.6]
Mean glucose and GMI
- Mean glucose (mean ± SD)
- 8.4 ± 1.1 mmol/L
- GMI
- 6.9%
Time using closed-loop
- Time using closed-loop, median [IQR]
- 94.7% [90.0, 96.9]
TIR (3.9-10 mmol/L) by age
- Users ≤6 years old (mean ± SD)
- 66.9 ± 11.7%
- Users ≥65 years (mean ± SD)
- 81.8 ± 8.7%
- TIR increased by age
Original publication
Real-World Evidence Analysis of a Hybrid Closed-Loop System. J Diabetes Sci Technol. Published 8 July 2023. doi:10.
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