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

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 & GE;30 days of continuous glucose monitor data, and & GE;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 & PLUSMN; 11.5% (mean & PLUSMN; SD) for all users and increased by age from 66.9 & PLUSMN; 11.7% for users & LE;6 years old to 81.8 & PLUSMN; 8.7% for users & GE;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 & PLUSMN; 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.

Automated summary

We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system. Users from 15 countries across different age groups who used the system between May 9, 2022, and December 3, 2022, were included in the analysis (N = 1805). The results showed that glycemic outcomes from this real-world evidence are comparable to previous randomized controlled studies, confirming the efficacy of this hybrid closed-loop system in real-world settings.