Journal
DIABETES TECHNOLOGY & THERAPEUTICS
Volume 25, Issue 6, Pages 431-436Publisher
MARY ANN LIEBERT, INC
DOI: 10.1089/dia.2023.0042
Keywords
Type 1 diabetes; Artificial pancreas; Aspart; Faster insulin aspart; Closed-loop insulin delivery; Very young children; Toddlers
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This study evaluated the use of hybrid closed-loop (HCL) insulin delivery with faster insulin aspart (Fiasp) in very young children with type 1 diabetes (T1D). The results showed that there was no significant difference in glycemic control between HCL with Fiasp and standard insulin aspart (IAsp) in children aged 2-6 years with T1D.
We evaluated the use of hybrid closed-loop (HCL) insulin delivery with faster insulin aspart (Fiasp) in very young children with type 1 diabetes (T1D). In a double-blind, multicenter, randomized, crossover study, children aged 2-6 years with T1D underwent two 8-week periods of HCL using CamAPS FX with Fiasp and standard insulin aspart (IAsp), in random order. Primary endpoint was between-treatment difference in time in target range 3.9-10.0 mmol/L. We randomized 25 participants: mean (+/- standard deviation) age 5.1 +/- 1.3 years, baseline HbA1c 55 +/- 9 mmol/mol. Time in range was not significantly different between interventions (64% +/- 9% vs. 65% +/- 9% for HCL with Fiasp vs. IAsp; mean difference -0.33% [95% confidence interval: -2.13 to 1.47; P = 0.71]). There was no significant difference in time with glucose <3.9 mmol/L. No post-randomization severe hypoglycemia or diabetic ketoacidosis events occurred. Use of Fiasp with CamAPS FX HCL demonstrated no significant difference in glycemic outcomes compared with IAsp in very young children with T1D. Clinical trials registration: NCT04759144.
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