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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.

Accepted version
Peer-reviewed

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Type

Article

Change log

Authors

Allen, Janet M 
Boughton, Charlotte K  ORCID logo  https://orcid.org/0000-0003-3272-9544
Cezar, Alina 
Hartnell, Sara 

Abstract

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.

Description

Keywords

Artificial pancreas, Aspart, Closed-loop insulin delivery, Faster insulin aspart, Toddlers, Type 1 diabetes, Very young children, Humans, Child, Child, Preschool, Diabetes Mellitus, Type 1, Insulin Aspart, Hypoglycemic Agents, Cross-Over Studies, Blood Glucose, Insulin, Double-Blind Method

Journal Title

Diabetes Technol Ther

Conference Name

Journal ISSN

1520-9156
1557-8593

Volume Title

Publisher

Mary Ann Liebert Inc