Glycemic and Psychosocial Outcomes of Advanced Hybrid Closed-Loop Therapy in Youth With High HbA1c: A Randomized Clinical Trial
Authors' conclusion
AHCL should be encouraged in youth with suboptimal glycemia, as AHCL improves glycemia. However, psychological support remains vital, as technology alone may not be able to reduce the burden of diabetes care in this subgroup.
Study context
- Population
- Youth with T1D on continuous subcutaneous insulin infusion (CSII) with or without continuous glucose monitoring (CGM), mean and most recent HbA1c >8.5% (65 mmol/mol); mean (SD) age 16.2 (2.5) years, HbA1c 9.8 (1.1)%randomized
- Participants
- 42 participants
- Comparison
- Advanced hybrid closed-loop vs treatment as usual
- Primary endpoint
- Between-group difference in HbA1c
- Follow-up
- 24 weeks
Methodological detailsmulticenter, 1:1 randomisation
- Multicenter
- 1:1 randomisation
Primary result
As reported in the abstract
HbA1c · study end (24 weeks)
Each group vs CSII ± CGMMean adjusted group difference, % (95% CI)P value
AHCL
−0.77(−1.45 to −0.09)
P = 0.027Each group vs CSII ± CGMMean adjusted group difference, mmol/mol (95% CI)P value
AHCL
−8.4(−15.8 to −1.0)
P = 0.027Secondary outcomes
| Outcome | Difference (%) (95% CI) | |
|---|---|---|
| TIR 70-180 mg/dL (masked CGM) | 19.1 (11.1–27.1) | |
| Time >180 mg/dL (masked CGM) | −17.7 (−26.6 to −8.8) | |
| −40−2002040Difference, % (linear scale) |
Psychosocial outcomes (PAID, quality of life, anxiety, depression, hypoglycemia fear) · study end
- No evidence for difference between the two groups
Safety
| Outcome | Difference (%) (95% CI) | |
|---|---|---|
| Time <70 mg/dL (masked CGM)No increase with AHCL | −0.8 (−2.7 to 0.6) | |
| −4−202Difference, % (linear scale) |
Original publication
Glycemic and Psychosocial Outcomes of Advanced Hybrid Closed-Loop Therapy in Youth With High HbA1c: A Randomized Clinical Trial. Diabetes Care. Published 13 September 2024. doi:10.
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