Hybrid Closed-Loop with Faster Insulin Aspart Compared with Standard Insulin Aspart in Very Young Children with Type 1 Diabetes: A Double-Blind, Multicenter, Randomized, Crossover Study
Primary result · Time in range 3.9-10.0 mmol/LResult — go to the resultMean difference −0.33 % 95% CI −2.13 to 1.47Authors' conclusion
Use of Fiasp with CamAPS FX HCL demonstrated no significant difference in glycemic outcomes compared with IAsp in very young children with T1D.
Study context
- Population
- Children aged 2–6 years with T1D; mean age 5.1 ± 1.3 years, baseline HbA1c 55 ± 9 mmol/molrandomized, crossover
- Participants
- 25 children
- Comparison
- Hybrid closed-loop (HCL) with faster insulin aspart (Fiasp) vs standard insulin aspart
- Primary endpoint
- Between-treatment difference in time in target range 3.9-10.0 mmol/L
Methodological detailsdouble-blind, multicenter, crossover
- Double-blind
- Multicenter
- Crossover
Primary result
Time in range 3.9-10.0 mmol/L
Mean difference
−0.33 %
95% CI −2.13 to 1.47
P = 0.71
By group
Fiaspvs IAsp
mean difference −0.33 % (95% CI −2.13 to 1.47); P = 0.71
As reported in the abstract
Further findings
- No significant difference in time with glucose <3.9 mmol/L
Safety
Severe hypoglycaemia or DKA · post-randomization
- No post-randomization severe hypoglycemia or DKA events occurred
Time with glucose <3.9 mmol/L
- No significant difference in time with glucose <3.9 mmol/L
Original publication
Hybrid Closed-Loop with Faster Insulin Aspart Compared with Standard Insulin Aspart in Very Young Children with Type 1 Diabetes: A Double-Blind, Multicenter, Randomized, Crossover Study. Diabetes Technol Ther. Published 29 May 2023. doi:10.
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