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
Authors' conclusion
In adults with T1DM, markedly elevated HbA1c, and substantial psychological burden, myLoop CamAPS FX significantly improved glycaemic control compared with standard therapy.
Study context
- Population
- Adults with T1D, HbA1c ≥ 9.0% and psychological vulnerability; mean age 32.7 ± 12.8 years, diabetes duration 13.3 ± 8.5 years, baseline HbA1c 10.5% ± 1.3%, time in range (TIR) 29.6% ± 18.9%randomised
- Participants
- 30 adults
- Comparison
- myLoop CamAPS FX hybrid closed-loop (HCL) vs optimised pre-study insulin therapy with Dexcom G6
- Primary endpoint
- Between-group differences in changes in HbA1c and TIR
- Follow-up
- 3 months
Methodological detailsmulticentre, open-label, parallel-group
- Multicentre
- Open-label
- Parallel-group
Primary result
As reported in the abstract
Each group vs controlEstimate (95% CI)
myLoop CamAPS FX
adjusted difference (HbA1c) −1.7 %(−2.6 to −0.8)
myLoop CamAPS FX
adjusted difference (TIR) 28.8 %(16.8–40.9)
- Mean HbA1c change, myLoop CamAPS FX
- −2.5%
- Mean TIR change, myLoop CamAPS FX
- +27.4%
- Mean HbA1c change, control
- −0.9%
- Mean TIR change, control
- −2.7%
Further findings
| Outcome | myLoop CamAPS FX | P value |
|---|---|---|
| Diabetes burnout (within-group change) · baseline to 3 monthsWithin-group change | median 3.5-2.0 | P = 0.012 |
| Psychological well-being (WHO-5, within-group change) · baseline to 3 monthsWithin-group change · exploratory | 12.0-14.0 | P = 0.031 |
- Diabetes burnout (within-group change): exploratory; not based on formal between-group efficacy testing
Diabetes burnout (within-group change) · baseline to 3 months
- Diabetes burnout decreased in both groups; only myLoop CamAPS FX moved from above to at or below the prespecified threshold
Anxiety, diabetes distress and depressive symptoms
- Anxiety-related symptoms decreased in both groups
- Changes in diabetes distress and depressive symptoms were modest; reductions in PHQ-9 and PAID scores observed only in the control group
- Exploratory
Original publication
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. Diabetes Obes Metab. Published 17 September 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →