Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Mar;24(3):511-521.
doi: 10.1111/dom.14605. Epub 2021 Dec 1.

Outcomes of hybrid closed-loop insulin delivery activated 24/7 versus evening and night in free-living prepubertal children with type 1 diabetes: A multicentre, randomized clinical trial

Eric Renard  1   2   3 , Nadia Tubiana-Rufi  4 , Elisabeth Bonnemaison  5 , Régis Coutant  6 , Fabienne Dalla-Vale  7 , Elise Bismuth  4 , Nathalie Faure  5 , Natacha Bouhours-Nouet  6 , Anne Farret  1   3 , Caroline Storey  4 , Aurélie Donzeau  6 , Amélie Poidvin  4 , Jessica Amsellem-Jager  6 , Jérôme Place  3 , Marc D Breton  8 ; Free-life Kid AP Study Group
Affiliations
Randomized Controlled Trial

Outcomes of hybrid closed-loop insulin delivery activated 24/7 versus evening and night in free-living prepubertal children with type 1 diabetes: A multicentre, randomized clinical trial

Eric Renard et al. Diabetes Obes Metab. 2022 Mar.

Abstract

Aim: To assess the safety and efficacy of hybrid closed-loop (HCL) insulin delivery 24/7 versus only evening and night (E/N), and on extended 24/7 use, in free-living children with type 1 diabetes.

Materials and methods: Prepubertal children (n = 122; 49 females/73 males; 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) from four centres were randomized for 24/7 versus E/N activation of the Tandem Control-IQ system for 18 weeks. Afterwards, all children used the activated system 24/7 for 18 more weeks. The primary outcome was the percentage of time spent in the 70-180 mg/dL glucose range (TIR).

Results: HCL was active 94.1% and 51.1% of the time in the 24/7 and E/N modes, respectively. TIR from baseline increased more in the 24/7 versus the E/N mode (52.9% ± 9.5% to 67.3% ± 5.6% [+14.4%, 95% CI 12.4%-16.7%] vs. 55.1% ± 10.8% to 64.7% ± 7.0% [+9.6%, 95% CI 7.4%-11.6%]; P = .001). Mean percentage time below range was similarly reduced, from 4.2% and 4.6% to 2.7%, and the mean percentage time above range decreased more in the 24/7 mode (41.9% to 30.0% [-11.9%, 95% CI 9.7%-14.6%] vs. 39.8% to 32.6% [-7.2%, 95% CI 5.0%-9.9%]; P = .007). TIR increased through the whole range of baseline levels and always more with 24/7 use. The results were maintained during the extension phase in those initially on 24/7 use and improved in those with initial E/N use up to those with 24/7 use. Neither ketoacidosis nor severe hypoglycaemia occurred.

Conclusions: The current study shows the safety and efficacy of the Tandem Control-IQ system in free-living children with type 1 diabetes for both E/N and 24/7 use; 24/7 use shows better outcomes, sustained for up to 36 weeks with no safety issues.

Keywords: children; clinical trial; closed-loop; glucose control; type 1 diabetes.

PubMed Disclaimer

References

REFERENCES

    1. Foster NC, Beck RW, Miller KM, et al. State of type 1 diabetes management and outcomes from the T1D exchange in 2016-2018. Diabetes Technol Ther. 2019;21(2):66-72.
    1. Karageorgiou V, Papaioannou TG, Bellos I, et al. Effectiveness of artificial pancreas in the non-adult population: a systematic review and network meta-analysis. Metabolism. 2019;90:20-30.
    1. Thabit H, Hovorka R. Coming of age: the artificial pancreas for type 1 diabetes. Diabetologia. 2016;59(9):1795-1805.
    1. Lal RA, Ekhlaspour L, Hood K, Buckingham B. Realizing a closed-loop (artificial pancreas) system for the treatment of type 1 diabetes. Endocr Rev. 2019;40(6):1521-1546.
    1. Boughton CK, Hartnell S, Allen JM, Hovorka R. The importance of prandial insulin bolus timing with hybrid closed-loop systems. Diabet Med. 2019;36(12):1716-1717.

Publication types