Real-World Evidence Analysis of a Hybrid Closed-Loop System.

Alwan, Heba; Wilinska, Malgorzata E; Ruan, Yue; Da Silva, Julien; Hovorka, Roman (2023). Real-World Evidence Analysis of a Hybrid Closed-Loop System. (In Press). Journal of diabetes science and technology, p. 19322968231185348. Diabetes Technology Society 10.1177/19322968231185348

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BACKGROUND

We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system.

METHODS

Users from 15 countries across different age groups who used the system between May 9, 2022, and December 3, 2022, and who had ≥30 days of continuous glucose monitor data, and ≥30% of closed-loop usage were included in the current analysis (N = 1805).

RESULTS

Time in range (3.9-10 mmol/L) was 72.6 ± 11.5% (mean ± SD) for all users and increased by age from 66.9 ± 11.7% for users ≤6 years old to 81.8 ± 8.7% for users ≥65 years. Time spent in hypoglycemia (<3.9 mmol/L) was 2.3% [1.3, 3.6] (median [interquartile range]). Mean glucose and glucose management indicator were 8.4 ± 1.1 mmol/L and 6.9%, respectively. Time using closed-loop was high at 94.7% [90.0, 96.9].

CONCLUSIONS

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.

Interest & Impact

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Citations

5 Citations in Web of Science ®
6 Citations in Scopus

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