Janet M Allen, United Kingdom
Wellcome-MRC Institute of Metabolic Science University of CambridgeAuthor Of 1 Presentation
OP040 - HYBRID CLOSED-LOOP WITH FASTER INSULIN ASPART COMPARED WITH STANDARD INSULIN ASPART IN VERY YOUNG CHILDREN WITH TYPE 1 DIABETES: A DOUBLE-BLIND, MULTICENTRE, RANDOMISED, CROSSOVER STUDY (ID 815)
Abstract
Background and Aims
Type 1 diabetes (T1D) remains challenging to manage in very young children, and performance of ultra-rapid insulins with hybrid closed-loop therapy has not been assessed in this age-group. We evaluate the use of hybrid closed-loop insulin delivery with faster insulin aspart (Fiasp) in very young children with T1D.
Methods
In a double-blind, multicentre, randomised, crossover study, very young children aged 2-6 years with T1D using insulin pump therapy were recruited. Participants underwent two 8-week periods comparing hybrid closed-loop using CamAPS FX with Fiasp and hybrid closed-loop using CamAPS FX with standard insulin aspart in random order. Primary endpoint was the between-group difference in time in target glucose range 3.9 to 10.0mmol/L at 8 weeks. Analysis was by intention-to-treat.
Results
We randomised 25 participants: mean (±SD) age 5.1±1.3 years, baseline HbA1c 55.5±8.5mmol/mol. The proportion of time sensor glucose was in the target range was not different between interventions (64±9% vs 64±9% for hybrid closed-loop with Fiasp vs hybrid closed-loop with standard insulin aspart; mean adjusted difference -0.31% [95% CI -2.13, 1.51; p=0.74]). There was no difference in time with sensor glucose <3.9mmol/L and >16.7mmol/L, and no difference in mean sensor glucose or glucose variability. Total daily insulin requirements did not differ (0.74 [IQR 0.68, 0.83] vs 0.71 [0.68, 0.83] units/kg/day; p=0.06). No severe hypoglycaemia or DKA events occurred.
Conclusions
Use of Fiasp in the CamAPS FX hybrid closed-loop system demonstrated no difference in glycaemic outcomes compared with standard insulin aspart in very young children with T1D.