Automated insulin delivery in free-life shows better glucose control when used 24/7 vs evening and night in pre-pubertal children with type 1 diabetes: the Free-life Kid AP Study
In children, 24/7 use is more effective in maintainingTIRcompared to evening + night use only, and improves TIR independently of baseline TIR or HbA1c level.
There were no adverse events with 24/7 use of the closed-loop insulin delivery system.
Young children have higher variability of insulin requirements as seen from observations on hybrid closed-loop insulin delivery systems.1
Diabetes management in young children is complicated by higher variability in insulin requirements, supporting fast-track clinical practice adoption of closed-loop in this vulnerable population.1
The main benefit of closed-loop insulin delivery in children may be expected at nighttime, while its use during daytime may raise safety issues when children are away from home.1
How was this study conducted?
This study assessed the efficacy and safety of 24/7 vs. evening + night use hybrid closed-loop insulin delivery in free-life in pre-pubertal kids with type 1 diabetes.
122 children were randomised to 24/7 vs. evening + night use hybrid closed-loop insulin delivery.
The primary outcome was % time in target range (TIR; 70-180 mg/dL).
Average change in TIR was +9.5% for evening + night and +14.6% for 24/7 (p = 0.001).
During the day, % TIR range changed from 55.7% to 58.4% for evening + night, and from 54.3% to 62.6% for 24/7 (p = 0.001 for evening + night vs. 24/7).
During the night, % TIR range changed from 54.2% to 77.2% for evening + night, and from 50.2% to 77.2% for 24/7 (p = 0.047 for evening + night vs. 24/7).
% TIR increased to a similar extent across all baseline HbA1c levels in both groups.
There were no safety issues in either group.
Perspectives
How does this study impact clinical practice?
24/7 use is more effective in keeping glucose in target range than use at evening + night only.
Closed-loop insulin delivery improves % TIR whatever baseline % TIR or HbA1c level.
The closed-loop insulin delivery system operated in auto-mode for 93.6% of time over 18 weeks when used 24/7 in pre-pubertal children with T1D.
The closed-loop insulin delivery system is safe with no harmful events when used 24/7 in this population.
24/7 closed-loop used in the study population for the extension phase will assist 36-week sustainability of the benefits of glucose control.
Dovc K, Boughton C, Tauschmann M, et al. Young children have higher variability of insulin requirements: observations during hybrid closed-loop insulin delivery. Diabetes Care. 2019 Jul;42(7):1344-7.
This is a highlights summary of an oral session given at the EASD 2020 Virtual Meeting and presented by:
Eric M. Renard, MD, PhD
Dept. of Endocrinology, Diabetes, Nutrition, and INSERM 1411 Clinical Investigation Centre, Montpellier University Hospital, INSERM, University of Montpellier, France
The presenting authors of the original session had no part in the creation of this conference highlights summary.
The content is produced by Infomedica. The summary text was drafted by Patrick Moore, PhD, and reviewed by Marco Gallo, MD, an independent external expert, and approved by Florian Toti, MD, the scientific editor of the program.
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