Six months of hybrid closed-loop therapy improves diabetes-specific positive well-being, and reduces diabetes distress and fear of hypoglycemia: secondary analysis of a randomized controlled trial
Authors' conclusion
These findings imply that HCL offers important psychological benefits. In particular, improvement in diabetes-specific positive well-being was observed 13 weeks after HCL initiation and maintained at 26 weeks. Reduction in the perceived frequency of hyperglycemia was also apparent by 26 weeks. Adjusted analyses showed significant reductions in diabetes distress and fear of hypoglycemia at 26 weeks, suggesting these benefits were apparent for people with particular characteristics.
Study context
- Population
- Adults with T1D; mean age 44±12 yearsrandomized
- Participants
- 120 adults
- Comparison
- Hybrid closed-loop (HCL) vs standard therapy
- HCLn = 61
- Standard therapyn = 59reference
- Primary endpoint
- Diabetes-specific psychological outcomes:
- Awareness and fear of hypoglycemia
- Diabetes-specific positive well-being
- Diabetes distress
- Treatment satisfaction
- Diabetes-specific QoL
- Follow-up
- Enrollment, mid-trial and end-trial
Methodological detailsmulticenter, open-label, parallel-group
- Multicenter
- Open-label
- Parallel-group
Primary result
As reported in the abstract
Δ
0.9
P = 0.042
unadjusted; better with HCL
Δ
1.0
P = 0.023
adjusted; better with HCL
Further findings
| Outcome | Δ | P value |
|---|---|---|
| Diabetes-specific positive well-being · 13 weeksHCL vs Standard therapy · unadjusted; better with HCL | 1.0 | P = 0.025 |
| Diabetes-specific positive well-being · 13 weeksHCL vs Standard therapy · adjusted; better with HCL | 1.1 | P = 0.01 |
| Diabetes distress · 26 weeksAdjusted; less with HCL | −6.4 | P = 0.039 |
| Fear of hypoglycemia: "maintain high" · 26 weeksAdjusted; less with HCL | −0.8 | P = 0.034 |
| Fear of hypoglycemia: "worry" · 26 weeksAdjusted; less with HCL | −1.8 | P = 0.048 |
| Perceived "unacceptably high glucose levels" · 26 weeksHCL vs Standard therapy · unadjusted; less with HCL | −1.1 | P < 0.001 |
| Perceived "unacceptably high glucose levels" · 26 weeksHCL vs Standard therapy · adjusted; less with HCL | −1.1 | P < 0.001 |
Treatment satisfaction, diabetes-specific quality of life (QoL), hypoglycemia awareness, perceived frequency of unacceptably low glucose
- HCL did not improve diabetes treatment satisfaction, diabetes-specific QoL, hypoglycemia awareness, or perceived frequency of unacceptably low glucose levels
Original publication
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