Metabolic and Psychological Effects of Mylife CamAPS FX Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes, Markedly Elevated HbA1c, and Psychological Vulnerability: The Hi-Loop Randomised Clinical Trial.
Abstract
Objective
To evaluate whether the myLoop powered by CamAPS FX hybrid closed-loop (HCL) system improves glycaemic control and to explore selected psychological outcomes in adults with Type 1 diabetes (T1DM), markedly elevated HbA1c, and predefined psychological burden. RESEARCH
Design
AND
Methods
In a 3-month multicentre, open-label, randomised, controlled, parallel-group clinical trial, adults with T1DM, HbA1c ≥ 9.0%, and psychological vulnerability were randomly assigned to myLoop CamAPS FX or optimised pre-study insulin therapy with Dexcom G6. Primary outcomes were between-group differences in changes in HbA1c and time in range (TIR) at 3 months. Psychological outcomes were prespecified as descriptive, exploratory within-group changes using validated questionnaires.
Results
Thirty participants were randomised (mean age 32.7 ± 12.8 years; diabetes duration 13.3 ± 8.5 years; baseline HbA1c 10.5% ± 1.3%, TIR 29.6% ± 18.9%). From baseline to 3 months, mean HbA1c and TIR changed by -2.5% and +27.4% in the myLoop CamAPS FX group and by -0.9% and -2.7% in the control group, with adjusted differences of -1.7% (95% CI: -2.6; -0.8) for HbA1c and 28.8% (95% CI: 16.8; 40.9) for TIR in favour of myLoop CamAPS FX. Diabetes burnout decreased in both groups, but only the myLoop CamAPS FX group moved from above to at or below the prespecified study threshold (median 3.5-2.0; p = 0.012). Psychological well-being increased in the mylife CamAPS FX group (World Health Organization Five Well-Being Index [WHO-5]: 12.0-14.0; p = 0.031), while anxiety-related symptoms decreased in both groups. Changes in diabetes distress and depressive symptoms were modest; reductions in PHQ-9 and PAID scores were observed only in the control group. These psychological findings are exploratory and are not based on formal between-group efficacy testing.
Conclusion
In adults with T1DM, markedly elevated HbA1c, and substantial psychological burden, myLoop CamAPS FX significantly improved glycaemic control compared with standard therapy. During HCL use, decreases in diabetes burnout and anxiety-related symptoms and an improvement in psychological well-being were observed; these exploratory psychological findings require confirmation in adequately powered between-group analyses.