Outcomes of hybrid closed-loop insulin delivery activated 24/7 vs evening and night in free-living prepubertal children with type 1 diabetes: A multicentre, randomized clinical trial
Diabetes, Obesity and Metabolism Dec 07, 2021
Renard E, Tubiana-Rufi N, Bonnemaison E, et al. - In free-living children with type 1 diabetes, the Tandem Control-IQ system is proved to be safe and efficacious for both evening and night (E/N) and 24/7 use; 24/7 use confers better results, sustained for up to 36 weeks with no safety issues.
A total of 122 prepubertal children (age, 8.6 ± 1.6 years; diabetes duration, 5.2 ± 2.3 years; insulin pump use, 4.6 ± 2.5 years; HbA1c 7.7% ± 0.7%/61 ± 5 mmol/mol) were randomly assigned for 24/7 vs E/N activation of the Tandem Control-IQ system for 18 weeks.
The % of time spent in the 70-180 mg/dL glucose range (TIR) was assessed (primary outcome).
In the 24/7 vs the E/N mode, a greater increase in TIR from baseline was evident (52.9% ± 9.5% to 67.3% ± 5.6% [+14.4%] vs 55.1% ± 10.8% to 64.7% ± 7.0% [+9.6%]).
Mean % time below range was similarly decreased, from 4.2% and 4.6% to 2.7%, and the mean % time above range reduced more in the 24/7 mode (41.9% to 30.0% vs 39.8% to 32.6%).
TIR rose always more with 24/7 use, and extension phase revealed maintained outcomes in those initially on 24/7 use and improvement of results in those with initial E/N use up to those with 24/7 use.
Ketoacidosis or severe hypoglycaemia did not occur.
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