A Randomized Closed-loop Trial in Very Young Children with Type 1 Diabetes

Julia Ware, Janet M Allen, Charlotte K Boughton, Malgorzata E Wilinska, Sara Hartnell, Ajay Thankamony, Carine Carine de Beaufort, Ulrike Schierloh, Elke Froehlich- Reiterer, Julia K Mader, Thomas M Kapellen, Birgit Rami-Merhar, Martin Tauschmann, Katrin Nagl, Sabine E Hofer, Fiona Campbell, James Yong, Korey Hood, Julia Lawton, Stephane RozeJudy Sibayan, Laura Bocchino, Craig Kollman, Roman Hovorka*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

ABSTRACT
Background
The possible advantage of hybrid closed-loop therapy as compared with sensor-augmented pump therapy in very young children with type 1 diabetes is unclear.

Methods
This multi-center, randomized crossover trial, recruited children aged 1 to 7 years with type 1 diabetes on insulin pump therapy from seven centers across the UK, Austria, Luxembourg and Germany. Participants underwent two 16-week periods comparing the CamAPS FX closed-loop application with sensor-augmented pump therapy (control) in random order. Primary endpoint was the between-treatment difference in time in target glucose range (70 to 180mg/dL) measured by sensor glucose levels. Analysis was by intention-to-treat.

Results
We randomized 74 participants (mean±SD age 5±2 years, baseline HbA1c 7.3±0.7% [57±7mmol/mol]). The proportion of time with glucose in target range was 8.7 percentage points (95% CI 7.4 to 9.9) higher during closed-loop compared to control period (p<0.001). Time with glucose >180mg/dL was 8.5 percentage points lower (95% CI 7.1 to 9.9; p<0.001), mean glucose 12.6mg/dL lower (95% CI 9.0 to 14.4; p<0.001), and glycated hemoglobin 0.4% ([3.9mmol/mol], 95% CI 0.3 to 0.5 [2.9 to 4.9]; p<0.001) lower with closed-loop than with control therapy. Time in hypoglycemia (<70mg/dL) was similar between periods (p=0.74). Median (IQR) closed-loop usage was 95% (92, 97) over 16-weeks. One severe hypoglycemia event occurred during closed-loop period. One non-treatment related serious adverse event occurred.

Conclusions
In the present study a hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing time in hypoglycemia.
Original languageEnglish
Pages (from-to)209-219
Number of pages11
JournalNew England Journal of Medicine
Volume386
Issue number3
DOIs
Publication statusPublished - 20 Jan 2022

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